PSM ProductsHIV/AIDS List

LIST OF ARV PHARMACEUTICAL PRODUCTS
classified according to the Global Fund Quality Assurance Policy
Edition: Version 131 - 22nd December 2016
The list is an overview of pharmaceutical products subject to the Global Fund Quality Assurance Policy that are listed in National and/or WHO standard treatment guidelines
and classified according to the various options (A, B, and ERP reviewed) defined in the Global Fund Quality Assurance Policy (July 2009, amended in December 2010). The
list is developed as a tool to assist Principal Recipients (PR) of Global Fund grants to identify the status of finished pharmaceutical products according to the Global Fund
Quality Assurance Policy.
The pharmaceutical products are classified based on the following information
A classified product - Listed on WHO prequalification list;

B classified product - Stringent NDRA Registration letter/Marketing Authorization;
ERP reviewed product- Permitted for time-limited procurement based on advice by the Expert Review Panel (ERP);
Please note that the list is not an exhaustive list. A PR can procure product(s) not listed in the current list as long as PR demonstrates that the product
is compliant with the Global Fund Quality Assurance Policy.
The Global Fund list includes the following information:
- "Important Notes" for helpful information;

- A, B, and ERP reviewed products;
- Period validity of the ERP reviewed products;
- "+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product ( i.e. co-blister)
- [A+B]+C means A and B are in fixed-dose formulation and C is co-packaged
YELLOW signifies a new entry; PINK signifies modification of an existing entry.
For more information, please look at:

http://www.theglobalfund.org/en/about/procurement/list/
Edition: Version 131, 22nd December 2016 List of AIDS drugs classified according to the GF QA Policy 1/49
Expert Review Panel (ERP): Expert Review Panel is an independent technical body composed of external technical experts, hosted by WHO Department of Essential
Medicines and Pharmaceutical Policies, to review the potential risks/benefits associated with the use of FPPs that are not yet WHO-prequalified or SRA-authorized and to
advise the Global Fund in its decision on whether to allow grant funds to be used to procure FPP. ERP reviewed products can be procured for a limited time (maximum 12
months). However, under certain circumstances, it is possible to extend the recommendation period. Contracts to supplier/manufacturer for an ERP reviewed products
should not be longer than the validity period of the recommendation of that product. For detail information on ERP process and Quality Assurance information, please look at
http://www.theglobalfund.org/en/procurement/quality/?lang=en
Procurement of ERP Reviewed Products: Principal Recipients (PRs) must inform the concerned Fund Portfolio Manager (FPM) at the Global Fund in writing by filling
the Notification Form ( available on website) if they intend to procure
ERP-reviewed product(s). The Global Fund Secretariat will review the notification request and upon issuing a no objection letter to the PR for the requested selection,
procurement can only proceed.
Important Notes
This List may be used by Principal Recipients of Global Fund grants when considering options with respect to procurement of pharmaceutical products pharmaceutical
products subject to the Global Fund Quality Assurance Policy. The list aims at providing countries with information that will assist them in their procurement options. Please
note that the list is not designed to be a basis for countries to select medicines to be included in their National Treatment Guidelines or to replace any applicable and legally
required procurement processes. The Global Fund requires its grant recipients to comply with applicable procurement laws and provides the list only for the identification
of products/manufacturers that comply with the Global Funds quality assurance policy. It is important to note that there is no strict requirement to procure
according to the list, as long as the Principal Recipients can ensure that the product selected is compliant with the Quality Assurance policy criteria. Furthermore, the
Principal Recipient should not rely solely on the information provided in the list but should obtain evidence of products compliance with the Quality Assurance policy. For the
above reasons, we strongly encourage users to ensure they are using the most recent version on our website when conducting procurement.
The Lists will be updated regularly based on evidence received by the Global Fund. Interested parties are invited to supply information and evidence of
products meeting the policy criteria on an ongoing basis. For the above reasons, we strongly encourage users to ensure they are using the most recent version on
our website when conducting procurement.
According to the Global Fund QA policy, if there are two or more A or B classified manufacturers available for any given product AND the product is
available from these manufacturers (available-means that the manufacturer can supply the selected product within 90 days after receiving the
Purchase Order), then such product must be procured from A or B classified product manufacturers. The PR must notify by writing to the Global
Fund Secretariat (Fund Portfolio Manager) and recieve the "No Objection" letter from GF secretariat before procuring any products complying with
option " ERP Reviewed".
For ease of reference, each "product" has been identified in this list with a unique "Product reference number" (Column A). Please see examples
below.
Several different dosage forms may be grouped under the same Product Reference Number and therefore will be considered the same type of products when identifying the
number of available manufacturers for the application of this policy. These products share the same dosing protocol, target the same population, and there are no fundamental
differences among them. For example, within solid forms, some capsules will have same reference number as tablets while within liquids, oral solution and suspension are
grouped together.Similarly, the entero coated tablet or dispersible tablet will not share the same reference number as non entero coated or dispersible tablets.
Produc WHO Pre-

International Global Fund
t Strength Dosage form Supplier/Manufacturer qualified/ Manufacturing site Country Material Pack
Non-proprietary name QA Standard
Ref.No SRA
XYZ 50mg Tablet "Pharma Company A-B Yes "Pharmaville" Country A HDPE bottle 60
16
A"
100mg Tablet "Pharma Company A-B Yes "Pharmaville" Country B HDPE bottle 60
17
B"
The example above shows 2 different variants of the same medicine. Because the strength is different, it is considered 2 different products (there are two different reference
numbers 16 and 17). If the strength had been the same but the dosage form had been different (i.e. tablet and liquid) it would also have been considered two different
"products".
Produc WHO Pre-

International Global Fund
t Strength Dosage form Supplier/Manufacturer qualified/ Manufacturing site Country Packaging
Non-proprietary name QA Standard
Ref.No SRA
ABC 150mg
"Pharma Company A-B Tablet
Yes "Pharmaville" Country A Blister, 10, 60
25
A" HDPE bottle
Capsules "Pharma Company A-B Yes "Pharmaville" Country B HDPE 60, 10
B" Bottle,
In this second example both products have same reference number (25) because both manufacturers are supplying the same strength and the dosage forms are considered
similar as per explanation above.
Disclaimer:
The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose, including in regard of its safety and/or efficacy in the treatment of
HIV/AIDS, HCV,tuberculosis or malaria. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal
Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to make a
purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Funds quality assurance policy. The Global Fund
does not warrant or represent that the products listed have obtained regulatory approval for use of treatment of any disease in any particular country of the world, or that their
use is otherwise in accordance with the national laws and regulations of any country, including, but not limited to, intellectual property laws. The Global Fund disclaims any
and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement,
distribution and use of any product included in the list.
List of A or B products:
If there are two or more A or B products available, then the product must be procured from one of the A or B products.
Note: if the product intended for selection is not listed in this list , please refer to the List of ERP ( Expert Review Panel) Reviewed Products which are
permitted for time limited procurement:
WHO
Global
International Non- Supplier/ Prequalifi
Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack
proprietary name Manufacturer(s) cation/
o Standard
SRA
1 Abacavir (ABC) 20 mg / ml Oral solution ViiV HealthCare A Yes Mississauga, Ontario Canada HDPE bottle 240ml
Cipla Limited, L-139
Oral 240ml,
Abacavir (ABC) as sulfate 20 mg / ml Cipla Ltd. A -B Yes to L-146 Verna Goa; India HDPE Bottle
Solution 100ml
Indore
Oral Meditabs
Abacavir (ABC) as sulfate 20 mg / ml A Yes Satara, Maharastra India PET Bottle 100ml
Solution Specialities Pvt Ltd
Unit III 22-110

Industrial
Oral development Area
Abacavir (ABC) as sulfate 20 mg / ml Hetero labs limited A Yes India HDPE Bottle 240ml
Solution Jeedimetla,
Hyderabad Andhra
Pradesh, India
Unit III, Survey No.

313 &314 Bachupally,
Oral Aurobindo Pharma
Abacavir (ABC) 20 mg / ml B Yes Quthubullapur India HDPE Bottle 240ml
Solution Ltd
Mandal Hyderabad,
Andhra Pradesh
Dispersible A-33, MIDC

2 Abacavir (ABC) as sulfate 60 mg Cipla Ltd. A -B Yes India HDPE Bottle 60
Tablet Patalganga
Mylan Laboratories Sinnar, Nashik,
Abacavir (ABC) as sulfate 60 mg Tablet A -B Yes India HDPE 60
Ltd Maharashtra
A-23, MIDC HDPE
3 Abacavir (ABC) 300 mg Tablet Cipla Ltd. A-B Yes India 60
Patalganga Bottle,
Glaxo Operations UK,
Ltd, Ware,
Herthfordshire, UK;
Abacavir (ABC) 300 mg Tablet ViiV HealthCare A-B Yes UK Blister 60
GSK, Poznan
(packaging and
release), Poland
WHO
Global
o Standard
SRA
HDPE
Mylan Laboratories Sinnar,Nashik, 60;
Abacavir (ABC) 300 mg Tablet A-B Yes India Bottle;
Ltd Maharashtra 6*10
Blister
Sun HDPE
Paonta Sahib, 60;
Abacavir (ABC) 300 mg Tablet Pharmaceutical A Yes India Bottle;
Himachal Pradesh 6*10
Industries Ltd Blister
36/7,
HDPE
Film coated Strides Arcolab Suragajakkanahalli 60;
Abacavir (ABC) as sulfate 300 mg A-B Yes India Bottle;
Tablet Limited Indlavadi cross Anekal 6*10
Blister
Taluk Bangalore
Unit III 22 - 110,

Industrial HDPE
60, 100,
development Area, Bottle;
Abacavir (ABC) 300 mg Tablet Hetero labs limited A-B Yes India 500;
Jeedimetla, Blister Film
10
Hyderabad -500 055 Package
Andhra Pradesh,
Unit III, Survey No

313 Bachyupally,
Quthubullapur
Aurobindo Pharma Mandal Hyderabad, HDPE
Abacavir (ABC) 300 mg Tablet B Yes India 60 ;
Ltd Andhra Pradesh Bottle;
Unit-VII (SEZ),
Mahaboob Nagar
(DT), Andhra Pradesh

313 and 314,
HDPE
Aurobindo Pharma Bachupally 30, 60;
4 Abacavir + Lamivudine 60 mg + 30 mg Tablet B Yes India Bottle;
Ltd Quthubullapur 10*10
Blister
Mandal Hyderabad,
Andhra Pradesh
Abacavir (as Sulfate)+ Mylan Laboratories Sinnar,Nashik,

60 mg + 30 mg Tablet A-B Yes India HDPE bottle 30, 60
Lamivudine Ltd Maharashtra
WHO
Global
o Standard
SRA
Hetero Labs Limited

Unit V HDPE bottle
30
SEZ Unit I in APIIC
Abacavir+Lamivudine 60 mg + 30 mg Tablet Hetero labs limited B Yes
SEZ Polepally Village, India Alu-Alu
10X10
Jadcherla Mandal blisters
Mahaboob Nagar
Tablets for HDPE

Abacavir Sulfate + A-33, MIDC 60, 120;
5 60 mg + 30 mg oral Cipla Ltd. A-B Yes India container;
Lamivudine Patalganga 10
suspension Blister
Tablets for
Abacavir Sulfate + Mylan Laboratories Sinnar,Nashik,
60 mg + 30 mg oral B Yes India HDPE bottle 60
Lamivudine Ltd Maharashtra
suspension
Abacavir and Lamivudine Tablets for
Mylan Laboratories Waluj, Aurangabad,
6 Tablets for Oral 120 mg / 60 mg Oral B Yes India HDPE bottle 30, 2000
Ltd Maharashtra,
Suspension Suspension
Unit - III Survey No.

313 & 314, Bachupally, HDPE
600 mg + 300 Aurobindo Pharma 30;
7 Abacavir + Lamivudine Tablet B Yes Quthubullapur India Bottle;
mg Ltd 10
Mandal Hyderabad, Blister
Andhra Pradesh
Ware,Hertfordshire; 30
HDPE Bottle
Aranda de Duero,
600 mg + 300 Tablet Film Glaxo SmithKline UK, Spain,
Abacavir + Lamivudine B Yes Burgos;
mg coated Ltd. USA
Research Triangle 30
Blister
Park, NC
HDPE
Abacavir Sulfate+ 600 mg + 300 A-33, MIDC 30;
Tablet Cipla Ltd. B Yes India Bottle;
Lamivudine mg Patalganga, 3*10
Blister
600 mg + 300 Mylan Laboratories Sinnar,Nashik,
Abacavir + Lamivudine Tablet A-B Yes India HDPE Bottle 28; 30
mg Ltd Maharashtra
Hetero Labs Limited,
Unit-V SEZ Unit I
600 mg + 300 HDPE Bottle 30
Abacavir + Lamivudine Tablet Hetero labs limited B Yes Survey No. 439, 440, India
mg Blister 10's x 10
441 & 458 Mahaboob
Nagar.
WHO
Global
o Standard
SRA
Abacavir (as Sulfate)+
60 mg + 30 mg + Mylan Laboratories Sinnar,Nashik,
8 Lamivudine + Tablet A Yes India HDPE 60
60 mg Ltd Maharashtra
Zidovudine
Sun
Abacavir + Lamivudine + 300 mg + 150 mg Paonta Sahib,
9 Tablet Pharmaceutical A Yes India HDPE bottle 60
Zidovudine + 300 mg Himachal Pradesh
Industries Ltd
Ltd, Ware,
Abacavir + Lamivudine + 300 mg + 150 mg Hertfordshire, UK; HDPE Botte 60;
Tablet ViiV HealthCare A-B Yes UK
Zidovudine + 300 mg GSK, Poznan Blister, 40; 60
(packaging and
release), Poland
Abacavir (as Sulfate)+
300 mg + 150 mg Mylan Laboratories Sinnar,Nashik,
Lamivudine + Tablet A-B Yes India HDPE Bottle 60
+ 300 mg Ltd Maharashtra
Zidovudine
Blister Card
Unit III, Survey 313 &
Contains:
314, Bachupally, PVC / PVdC
Abacavir + [Lamivudine 300 mg + 150 mg Aurobindo Pharma 10 + 10
Tablet B Yes Quthubullapur India / Aluminum
+ Zidovudine] + 300 mg Ltd Each Carton
Mandal, Hyderbad, Foil
Contains:
Andhra Pradesh,
60 + 60
Bristol-Myers Bottle
10 Atazanavir 50 mg / 1.5g Oral powder B Yes Hounslow UK 180g
Squibb (HDPE)
Bottle
Hard Bristol-Myers 60,
11 Atazanavir 100 mg B Yes Hounslow UK (HDPE)
Capsule Squibb 60
Blister (alu)
Emcure
HDPE
Atazanavir 100 mg Capsule Pharmaceuticals B Yes Hinjwadi, Pune India 60;
bottle;
Limited
Unit-VII (SEZ), 60,500
Aurobindo Pharma HDPE bottle
Atazanavir 100 mg Capsule B Yes Mahaboob Nagar India
Ltd Blister
(DT), Andhra Pradesh 10
Evansville, Indianna,
Bristol-Myers Mount Vernon,
12 Atazanavir 150 mg Capsule A Yes USA HDPE bottle 60
Squibb Indianna (primary
packaging)
WHO
Global
o Standard
SRA
Bottle
Capsule Bristol-Myers 60
Atazanavir 150 mg B Yes Hounslow UK (HDPE)
Hard Squibb 60
Blister (alu)
Emcure
HDPE
bottle;
Limited
Sinnar, Nashik
District, Maharashtra,
Mylan Laboratories India;
Atazanavir ( as Sulfate) 150 mg Capsule A -B Yes India HDPE Bottle 30, 100
Ltd Waluj, Aurangabad,
Maharashtra,
India
Unit-VII (SEZ),
Aurobindo Pharma HDPE bottle 60,180, 500
Atazanavir ( as Sulfate) 150 mg Capsule B Yes Mahaboob Nagar India
Ltd Blister 10
Bottle
Capsule Bristol-Myers 60,
13 Atazanavir 200 mg B Yes Hounslow UK (HDPE)
Hard Squibb 60
Blister (alu)
Emcure
HDPE
bottle;
Limited
Unit-VII (SEZ),
Aurobindo Pharma HDPE bottle 60,180, 500
Atazanavir 200 mg Capsule B Yes Mahaboob Nagar India
Ltd Blister 10
Bristol-Myers
14 Atazanavir ( as Sulfate) 300 mg Capsule B Yes Evansville, Indiana, USA HDPE Bottle 30
Squibb
Emcure
Atazanavir ( as Sulfate) 300 mg Capsule Pharmaceuticals B Yes Hinjwadi, Pune India HDPE Bottle 30
Limited
WHO
Global
o Standard
SRA
Sinnar, Nashik
Mylan Laboratories India;
Atazanavir ( as Sulfate) 300 mg Capsule A- B Yes India HDPE Bottle 30, 100
Ltd Waluj, Aurangabad,
Maharashtra,
India
Unit-VII (SEZ), 30, 90,500

Aurobindo Pharma HDPE bottle
Atazanavir ( as Sulfate) 300 mg Capsule B Yes Mahaboob Nagar India
Ltd Blister
(DT), Andhra Pradesh 10
Mylan Laboratories Sinnar,Nashik,
15 Atazanavir+ Ritonavir 300mg + 100mg Tablet A-B Yes India HDPE Bottle 30, 90, 120
Ltd Maharashtra
Emcure
Tablet
Atazanavir+Ritonavir 300mg+100mg Pharmaceuticals B Yes Hinjwadi, Pune India HDPE Bottle 30
(FDC)
Limited
Cartons containing 5
blister packs
(consisting of
PVC/Aclar film and
[Atazanavir Sulfate+ [300 mg / 100
co-packaged Mylan Laboratories Sinnar, Nashik District coated aluminum
16 Ritonavir] +[Lamivudine mg] +[150 mg / B Yes India PVC blister foil), each containing
Tablets Ltd 422 113, Maharashtra two 1-day cards, for a
and Zidovudine] 300 mg] 10 day supply. Three
cartons are further
packaged together for
a 30 day supply
Astra Zeneca, Indiana

17 Daclatasvir 30mg Tablet BMS Pharma UK A-B Yes Batch release:BMS USA Blister 28 (2x14's)
Italy
Astra Zeneca, Indiana

18 Daclatasvir 60mg Tablet BMS Pharma UK A-B Yes Batch release:BMS USA Blister 28 (2x14's)
Italy
WHO
Global
o Standard
SRA
Janssen Ortho LLC,
Gurabo, Puerto Rico,
Janssen Infectious United States
Diseases - (Manufacturing and
Darunavir (as
19 75 mg Tablets Diagnostics BVBA/ A-B Yes release testing); Puerto Rico HDPE Bottle 480
Ethanolate)
Pharmacare South Janssen-Cilag SpA,
Africa Latina, Italy (Testing
and final QC release
and packaging)
Plot No. 15B, Phase 1
Darunavir (as A, Verna Industrial
75 mg Tablets Lupin Limited B Yes India HDPE Bottle 480
Ethanolate) Area, Verna, Salcette
Goa - 403722
Janssen Ortho LLC,
Janssen Infectious United States
Diseases - (Manufacturing and
Darunavir (as
20 150 mg Tablets Diagnostics BVBA/ A-B Yes release testing); Puerto Rico HDPE Bottle 240
Ethanolate)
Pharmacare South Janssen-Cilag SpA,
Africa Latina, Italy (Testing
and final QC release
and packaging)
Goa - 403722
Goa - 403722
Janssen Infectious
Diseases -
Jansen Ortho LLc,
21 Darunavir 400 mg Tablets Diagnostics BVBA/ B Yes Puerto Rico HDPE Bottle 60
Gurabo
Pharmacare South
Africa
WHO
Global
o Standard
SRA
Hetero Labs
Darunavir 400mg Tablet B Yes UNIT-III, Hyderabad India HDPE Bottle 60
limited

400mg Tablet Lupin Limited B Yes India HDPE Bottle 60
Goa - 403722
Janssen Infectious
Diseases -
Jansen Ortho LLc,
22 Darunavir 600 mg Tablets Diagnostics BVBA/ B Yes Puerto Rico HDPE Bottle 60
Gurabo
Pharmacare South
Africa
Janssen Ortho LLC,

USA (manufacturing
and release testing);
Janssen Infectious
Janssen-Cilag SpA,
Diseases -
Latina, Italy
Darunavir 600 mg Tablets Diagnostics BVBA/ A Yes USA HDPE Bottle 60
(packaging, testing
Pharmacare South
and QC release);
Africa
Pharmacare Limited,
Korsten, Port
Elizabeth, South Africa
(QC release)
Hetero Labs
Darunavir 600mg Tablet B Yes UNIT-III, Hyderabad India HDPE Bottle 60
limited

600mg Tablet Lupin Limited B Yes India HDPE Bottle 60
Goa - 403722
800mg Tablet Lupin Limited B Yes India HDPE Bottle 30 & 90
Goa - 403722
WHO
Global
o Standard
SRA
Mount Vernon,
Powder for Indiana, USA; Anagni
Bristol-Myers
23 Didanosine (ddI) 2g Oral A Yes (Secondary packaging USA Glass Bottle 2g
Squibb
Solution and batch release),
Italy
Powder for
Bristol-Myers Meymac France
24 Didanosine (ddI) 10 mg / ml Oral B Yes HDPE bottle 2g
Squibb Evansville, Indiana, USA
Solution
Bristol-Myers
25 Didanosine (ddI) 25 mg Tablet A Yes Emcure, New jersy USA HDPE bottle 60
Squibb
Bristol-Myers
26 Didanosine (ddI) 50 mg Tablet A-B Yes Emcure, New jersy USA HDPE bottle 60
Squibb
Bristol-Myers
27 Didanosine (ddI) 100 mg Tablet A Yes Emcure, New jersy USA HDPE bottle 60
Squibb
Capsule
Mylan Laboratories Sinnar,Nashik, HDPPE
28 Didanosine (ddI) 125 mg Delayed A-B Yes India 30, 500
Ltd Maharashtra Bottle
release

Capsule 313 & 314, Bachupally,
Aurobindo Pharma HDPE bottle 30, 500;
Didanosine (ddI) 125 mg Delayed B Yes Quthubullapur India
Ltd Blister 14
release Mandal Hyderabad,
Andhra Pradesh
Bristol-Myers
29 Didanosine (ddI) 150 mg Tablet A-B Yes Emcure, New jersy USA HDPE bottle 60
Squibb
Capsule
30 Didanosine (ddI) 200 mg Delayed A-B Yes India HDPE bottle 30, 500
Ltd Maharashtra
release
Capsule
Barr Laboratories,
Didanosine (ddI) 200 mg Delayed B Yes Pomona, NY USA Bottle 30
Inc.
release

Capsule 313 & 314, Bachupally,
Aurobindo Pharma HDPE Bottle 30, 500;
Didanosine (ddI) 200 mg Delayed B Yes Quthubullapur India
Ltd Blister 10
release Mandal Hyderabad,
Andhra Pradesh
WHO
Global
o Standard
SRA
Capsule
31 Didanosine (ddI) 250 mg Delayed A-B Yes India HDPE Bottle 30, 500
Ltd Maharashtra
release
Mount Vernon,
Indiana, USA;
Bristol-Myers Anagni (Primary and
Didanosine (ddI) 250 mg Capsule A Yes USA Blister 30
Squibb secondary packaging
and batch release),
Italy
Capsule
Barr Laboratories,
Inc.
release

Capsule 313 & 314, Bachupally, HDPE
Aurobindo Pharma 30, 500
Didanosine (ddI) 250 mg Delayed B Yes Quthubullapur India bottle;
Ltd 10
release Mandal Hyderabad, Blister
Andhra Pradesh
Capsule
32 Didanosine (ddI) 400 mg Delayed A-B Yes India HDPE Bottle 30, 500
Ltd Maharashtra
release
Mount Vernon,
Indiana, USA;
Bristol-Myers Anagni (Primary and
Didanosine (ddI) 400 mg Capsule A Yes USA Blister 30
Squibb secondary packaging
and batch release),
Italy
Capsule
Barr Laboratories,
Inc.
release

Capsule 313 & 314, Bachupally, HDPE
Aurobindo Pharma 30, 500;
Didanosine (ddI) 400 mg Delayed B Yes Quthubullapur India bottle;
Ltd 5
release Mandal Hyderabad, Blister
Andhra Pradesh
WHO
Global
o Standard
SRA
Glaxo Operations UK
Ltd, Hertfordshire
(manufacturing and
Dolutegravir (as sodium quality control), UK;
33 50mg Tablets ViiV Healthcare A Yes UK Bottle 30
salt) Glaxo Wellcome S.A.,
Burgos (primary and
secondary packaging,
batch release), Spain
Aurobindo Pharma
Ltd, Unit VII, SEZ,
TSIIC, Plot No. S1,
Survey No.s 411, 425,
434, 435 & 458, Green
Dolutegravir (as sodium Aurobindo Pharma ANDA
50mg Tablets B Industrial Park, India HDPE bottle 30
salt) Ltd 208355
Polepally village,
Jedcherla Mandal,
Mahaboob Nagar
District, Telangana
State
Patheon Inc.
Oral Merck Sharp & Canada
34 Efavirenz (EFV) 30 mg / ml A-B Yes Mississauga, Ontario HDPE Bottle 180ml
Solution Dohme Limited Netherlands
Harlem
Merck Sharp & Manati, Puerto Rico
35 Efavirenz (EFV) 50 mg Capsule A Yes HDPE bottle 30
Dohme Limited Harlem Netherlands
Efavirenz (EFV) 50 mg Capsule Microlabs Ltd B Yes Verna, Goa India Bottle 30, 60, 90

Quthubullapur
HDPE
Aurobindo Pharma Mandal Hyderabad, 30
Efavirenz (EFV) 50 mg Capsule B Yes India bottle;
Ltd Andhra Pradesh 10
Blister
Unit-VII (SEZ),
Mahaboob Nagar
WHO
Global
o Standard
SRA
South Granville,
BN Haarlem
Merck Sharp &
36 Efavirenz (EFV) 50 mg Tablet A Yes (packager, responsible Australia HDPE bottle 30
Dohme Limited
for batch release in the
EU)
Efavirenz (EFV) 50 mg Tablet B Yes India HDPE Bottle 30, 90
Ltd Maharashtra
37 Efavirenz (EFV) 100mg Tablet B Yes India HDPE Bottle 30, 90
Ltd Maharashtra
313 &314 Bachupally, HDPE
Aurobindo Pharma 30, 500;
Efavirenz (EFV) 100mg Tablet B Yes Quthubullapur India Bottle;
Ltd 10
Andhra Pradesh
Sun
Dispersible
38 Efavirenz (EFV) 100mg Pharmaceutical A Yes Mohali, Punjab India HDPE Bottle 30
Tablet
Industries Ltd
Plot No. L-147, L147-1,
39 Efavirenz (EFV) 200 mg Capsule Cipla Ltd. A-B Yes India HDPE Bottle 90, 1000
Verna Goa,
Merck Sharp & Manati, Puerto Rico
Efavirenz (EFV) 200 mg Capsule A Yes HDPE bottle 90
Dohme Limited Harlem Netherlands
Sun HDPE
Paonta Sahib, 90;
Efavirenz (EFV) 200 mg Capsule Pharmaceutical A Yes India bottle;
Himachal Pradesh 90

Quthubullapur
HDPE
Aurobindo Pharma Mandal Hyderabad, 30, 90;
Efavirenz (EFV) 200 mg Capsule B Yes India bottle;
Blister
Unit-VII (SEZ),
Mahaboob Nagar
Efavirenz (EFV) 200 mg Capsule Microlabs Ltd B Yes Verna, Goa India Bottle 30,60,90
WHO
Global
o Standard
SRA
36/7,
Film coated Strides Arcolab Suragajakkanahalli
40 Efavirenz (EFV) 200 mg A-B Yes India HDPE bottle 90
Tablet Limited Indlavadi cross Anekal
Taluk Bangalore
South Granville,
BN Haarlem
Merck Sharp &
Efavirenz (EFV) 200 mg Tablet A Yes (packager, responsible Australia HDPE bottle 90
Dohme Limited
for batch release in the
EU)
Efavirenz (EFV) 200 mg Tablet B Yes India HDPE Bottle 30, 90
Ltd Maharashtra
Bristol-Myers Squibb
Pharma, Manati,
Puerto Rico;
Merck Sharp & Dohme
Australia Pty. Ltd,
Puerto Rico
South Granville,
Merck Sharp & Australia
41 Efavirenz (EFV) 600 mg Tablet A Yes Australia; HDPE bottle 30
Dohme Limited Netherlands
Merck Sharp &
China
Dohme, BV Haarlem,
The Netherlands;
Zhejiang Huahai
Pharmaceutical Co.,
Ltd, Zhejiang, China
Sun
Paonta Sahib, HDPE bottle 30;
Efavirenz (EFV) 600 mg Tablet Pharmaceutical A Yes India
Himachal Pradesh Blister; 30
Industries Ltd
Unit III Survey No.

313, Bachupally,
Quthubullapur
HDPE
Tablet Film Aurobindo Pharma Mandal, Hyderabad, 30,
Efavirenz (EFV) 600 mg B Yes India Bottle;
coated Ltd Andhra Pradesh 10
Blister
Unit-VII (SEZ),
Mahaboob Nagar
WHO
Global
o Standard
SRA
HDPE 28, 30;
Efavirenz (EFV) 600 mg Tablet A-B Yes India bottle;
Ltd Maharashtra
Blister 10
L-139 to L-146, Verna
Goa
India HDPE bottle 30, 500
Efavirenz (EFV) 600 mg Tablet Cipla Ltd. A-B Yes Quality Chemical
Uganda Blister 10
Industries Ltd,
Kampala
36/7,
Film coated Strides Arcolab Suragajakkanahalli
Efavirenz (EFV) 600 mg A-B Yes India HDPE bottle 30
Taluk Bangalore
Unit-III, Jeedimetla,
Hyderabad, Andhra
Tablet Film Pradesh, India; HDPE
Efavirenz (EFV) 600 mg Hetero labs limited A-B Yes India 28, 30, 250
coated Unit-V, Mahaboob Container
Nagar, Andhra
Pradesh, India
Macleods
HDPE
Efavirenz (EFV) 600 mg Tablet Pharmaceuticals A-B Yes Himachal Pradesh India 30
container
Limited
Emcure HDPE
30, 60;
Efavirenz (EFV) 600 mg Tablet Pharmaceuticals B Yes Hinjwadi, Pune India bottle;
3*10
Limited Blister
HDPE
30,60,90
Efavirenz (EFV) 600 mg Tablet Microlabs Ltd B Yes Verna, Goa India bottle;
10
Blister
Aspen Port Elizabeth ,
Pharmacare (Pty) Ltd, Korsten Port Layflat laminat
Bag(PET/Alu/ 30
Efavirenz (EFV) 600 mg Tablet Ltd.(trading as A HA649 Elizabeth, South Africa LLDPE) 30
Aspen Pharmacare) South Africa HDPE Bottle
Edict
HDPE
Efavirenz (EFV) 600 mg Tablet Pharmaceuticals B Yes Chennai India 30
container
Private Limited
WHO
Global
o Standard
SRA
Unit - III Survey No. 6 blisters

313 & 314, Bachupally, PVC/PE/Acl per box
Efavirenz + [Lamivudine 600 mg + [150 Aurobindo Pharma
42 Tablet B Yes Quthubullapur India ar-Al foil ; Each blister
+ Zidovudine] mg + 300 mg] Ltd
Mandal Hyderabad, Carton has 5 x
Andhra Pradesh (2+1)
36/7,
Efavirenz + [Lamivudine 600 mg + [150 Strides Arcolab Suragajakkanahalli
Tablet B Yes India HDPE bottle 30 + (60)
+ Zidovudine] mg + 300 mg] Limited Indlavadi cross Anekal
Taluk Bangalore
10-day supply (5 two-

Efavirenz + [Lamivudine 600 mg + [150 Co packed Mylan Laboratories Sinnar, Nashik District Blister day blister cards
B Yes India consisting of
+ Zidovudine] mg + 300 mg] Tablet Ltd 422 113, Maharashtra cards. PVC/PvDC film and
coated aluminum foil)
Patheon Inc.
Mississauga, Ontario
Efavirenz + Emtricitabine 600 mg + 200 Merck Sharp &
43 Tablet A Yes MSD BV Haarlem ( Canada HDPE bottle 30
+ Tenofovir mg + 300 mg Dohme Limited
packaging and batch
release site)
Sinnar,Nashik,
Maharashtra,
Efavirenz + Emtricitabine Waluj, Aurangabad,
600 mg + 200 Mylan Laboratories
+ Tenofovir Disoproxil Tablet A-B Yes Maharashtra; India HDPE bottle 28, 30, 100
mg + 300 mg Ltd
Fumarate Mylan Pithambur,
Dhar Dist., Madhya
Pradesh
Efavirenz + Emtricitabine 600 mg + 200 Plot No. L-147, L147-1,

Tablet Cipla Ltd. A Yes India HDPE Bottle 30
+ Tenofovir mg + 300 mg Verna Goa,
Unit-VII (SEZ),
Efavirenz + Emtricitabine 600 mg + 200 Aurobindo Pharma
Tablet B Yes Mahaboob Nagar India HDPE Bottle 30, 100
+ Tenofovir mg + 300 mg Ltd
WHO
Global
o Standard
SRA
Hetero Labs Limited,
Unit-V SEZ Unit I
Efavirenz + Emtricitabine 600 mg + 200 HDPE 28's, 30's
Tablet Hetero labs limited A-B Yes Survey No. 439, 440, India
+ Tenofovir mg + 300 mg Bottle and 500's,
441 & 458 Mahaboob
Nagar.
Shasun
Sun
Efavirenz + Emtricitabine 600 mg + 200 Pharmaceuticals Ltd,
Tablet Pharmaceutical A Yes India HDPE Bottle 30
+ Tenofovir mg + 300 mg Periyakalapet,
Industries Ltd
Pondicherry, India
Macleods
Efavirenz + Emtricitabine 600 mg + 200
Tablet Pharmaceuticals A-B Yes Kachigam, Damam India HDPE Bottle 30
+ Tenofovir mg + 300 mg
Limited
Efavirenz + Emtricitabine 600 mg + 200 Strides Arcolab Anekal Taluk,

Tablet A Yes India HDPE Bottle 30
+ Tenofovir mg + 300 mg Limited Bangalore, India
Bristol-Myers
Efavirenz + Emtricitabine 600 mg+200 Carrigtohill, County
Tablet Squibb and Gilead B Yes Ireland HDPE Bottle 30
+ Tenofovir Disoproxil mg+300 mg Cork
Sciences Ltd
Efavirenz + Emtricitabine 600 mg+200 Gilead Sciences, Patheon Inc.
Tablet B Yes Canada HDPE Bottle 30
+ Tenofovir Disoproxil mg+300 mg Inc. Mississauga, Ontario
Sinnar,Nashik,
Maharashtra;
Efavirenz+ Lamivudine + H-12 & H-13, M.I.D.C,
600 mg + 300 Mylan Laboratories
44 Tenofovir Disoproxil Tablet A- B Yes Waluj, Aurangabad India HDPE Bottle 30, 100
mg + 300 mg Ltd
Fumarate Maharastra; Mylan
Pithambur, Dhar Dist.,
Madhya Pradesh
WHO
Global
o Standard
SRA
Aurobindo Pharma
Efavirenz+ Lamivudine +
600 mg + 300 Aurobindo Pharma Limited Unit-VII 30, 100 &
Tenofovir Disoproxil Tablet B Yes India HDPE Bottle
mg + 300 mg Ltd (SEZ) Mahaboob 500
Fumarate
Nagar (Dt) AP;
Efavirenz+ Lamivudine +
600 mg + 300
Tenofovir Disoproxil Tablet Cipla Ltd. A-B Yes UNIT-II-Patalganga India HDPE Bottle 30
mg + 300 mg
Fumarate
Macleods
Efavirenz+ Lamivudine + Macleods Pharmaceuticals
600 mg + 300
Tenofovir Disoproxil Tablet Pharmaceuticals A-B Yes Limited India HDPE Bottle 30
mg + 300 mg
Fumarate Limited Baddi, District Solan,
Himachal Pradesh
Gilead Sciences,
45 Emtricitabine 10 mg/ml oral solution B Yes Country Cork Ireland Bottle 170ml
Inc.
Plot No. L-147, L147-1,
46 Emtricitabine 200 mg Capsule Cipla Ltd. A-B Yes India HDPE Bottle 30, 1000
Verna Goa,

313 & 314, Bachupally, HDPE
Aurobindo Pharma 30, 500
Emtricitabine 200 mg Capsule B Yes Quthubullapur India Bottle,
Ltd 10
Andhra Pradesh
HDPE
Mylan Laboratories Sinnar,Nashik, 30, 100;
Emtricitabine 200 mg Capsule A-B Yes India Bottle;
Ltd Maharashtra 2*10, 3*10
Blister
Gilead Sciences, HDPE
Emtricitabine 200 mg Capsule B Yes Foster City USA 30
Inc. Bottle,
(1+2) per
(Emtricitabine + Tablets co- Mylan Laboratories Sinnar,Nashik, Alu/Alu blister, 3
47 (200+200)+ 300 A Yes India
Nevirapine) +Tenofovir packed Ltd Maharashtra blister blisters in a
carton
Emtricitabine + Tablet Film Gilead Sciences, Granta Park Abington, Bottle
48 200 mg + 245 mg B Yes UK 30
Tenofovir coated Inc. Cambridge (HDPE)
WHO
Global
o Standard
SRA
Altana Pharma,
Oranienburg GmbH,
Germany
Emtricitabine + 200 mg + 300 Gilead Sciences, Patheon Inc.
Tablet A Yes Canada HDPE bottle 30
Tenofovir mg Inc. Mississauga, Ontario
South Africa
Aspen Pharmacare,
Port Elizabeth,

313 & 314, Bachupally,
Quthubullapur
Emtricitabine +
200 mg + 300 Aurobindo Pharma Mandal Hyderabad,
Tenofovir disoproxil Tablet B Yes India HDPE bottle 30
mg Ltd Andhra Pradesh
fumarate
Unit-VII (SEZ),
Mahaboob Nagar
Emtricitabine + HDPE
200 mg + 300 Mylan Laboratories Sinnar,Nashik, 28, 30,100;
Tenofovir Disoproxil Tablet A-B Yes India bottle;
mg Ltd Maharashtra 10
Fumarate blister
Emtricitabine +
200 mg + 300 Plot No. L-147, L147-1,
Tenofovir Disoproxil Tablet Cipla Ltd. A-B Yes India HDPE Bottle 30
mg Verna Goa,
Fumarate
Unit III 22 - 110,
Emtricitabine + Industrial
200 mg + 300 28, 30, 56 &
Tenofovir Disoproxil Tablet Hetero labs limited A-B Yes development Area, India HDPE bottle
mg 60
Fumarate Jeedimetla,
Hyderabad-500055
36/7,
Emtricitabine +
200 mg + 300 Strides Arcolab Suragajakkanahalli
Tenofovir Disoproxil Tablet A-B Yes India HDPE bottle 30
mg Limited Indlavadi cross Anekal
Fumarate
Taluk Bangalore
HDPE
Emtricitabine + Macleods
200 mg + 300 bottleAlu/Al 30;
Tenofovir Disoproxil Tablet Pharmaceuticals A Yes Kachigam, Daman, India
mg u 10 x 10
Fumarate Limited
blister
WHO
Global
o Standard
SRA
Emtricitabine + (Pty) Ltd, Korsten Port
200 mg + 300
Tenofovir Disoproxil Tablet Pharmacare Ltd A HA601 Elizabeth, South Africa HDPE bottle 30
mg
Fumarate South Africa
Shasun
Emtricitabine + Sun Pharmaceuticals
200 mg + 300
Tenofovir Disoproxil Tablet Pharmaceutical A Yes Limited, India HDPE bottle 30
mg
Fumarate Industries Ltd Periyakalapet,
Puducherry, India
Cartons containing 5
blister packs
(consisting of
[Emtricitabine + 200 mg /300 mg aluminum-aluminum
Co packed Mylan Laboratories Sinnar, Nashik District Blister blisters), each
49 Tenofovir Disoproxil co-packaged with B Yes India containing two 1-day
Tablet Ltd 422 113, Maharashtra cards. cards, for a 10 day
Fumarate]+Nevirapine 200 mg supply. Three cartons
are further packaged
together for a 30 day
supply
[Emtricitabine + 200 mg /300 mg Macleods

Co packed Alu/Alu (1 + 2)
Tenofovir Disoproxil co-packaged with Pharmaceuticals A Yes Kachigam, Daman, India
Tablet blister combipack
Fumarate]+Nevirapine 200 mg Limited
60+60 vials
Hoffmann-La
50 Enfuvirtide 90mg/ml Injection B Yes Basle Switzerland Vials of water for
Roche Inc.
inj+syringe
Janssen-Cilag
Janssen-Cilag SpA,
51 Etravirine 25mg Tablet International NV, A-B Yes Italy HDPE Bottle 120
Latina, Italy
Belgium
Borgo San Michele,
Latina
Janssen Infectious
Janssen-Cilag SpA,
Diseases -
Latina, Italy
52 Etravirine 100mg Tablet Diagnostics BVBA/ A-B Yes Italy HDPE Bottle 120
(Manufacturing,
Pharmacare South
packaging, release
Africa
testing and final QC
release)
Janssen-Cilag
Janssen-Cilag SpA,
53 Etravirine 200mg Tablet International NV, A-B Yes Italy HDPE Bottle 60
Latina, Italy
Belgium
Glaxo SmithKline Glaxo Wellcome
54 Fosamprenavir (FPV) 700 mg Tablet B Yes UK HDPE bottle 60
Ltd. Operations
WHO
Global
o Standard
SRA
Capsule Merck Sharp & Hertford Road, 180,270,
55 Indinavir (IDV) 200 mg B Yes UK HDPE Bottle
Hard Dohme Limited Hertfordshire 360
Hetero Labs Al/Al strip; 10;
57 Indinavir (IDV) 400 mg Capsule A Yes Hyderabad, Andhra India
Limited HDPE bottle 180
Pradesh, India
Merck Sharp &
Indinavir (IDV) 400 mg Capsule A Yes Elkton, Virgina USA HDPE bottle 180
Dohme Limited
Capsule Merck Sharp & Hertford Road, Bottle
Indinavir (IDV) 400 mg B Yes UK 18, 90, 180
Hard Dohme Limited Hertfordshire (HDPE)
Oral
56 Lamivudine (3TC) 10 mg / ml ViiV HealthCare A Yes Mississauga, Ontario Canada HDPE bottle 240ml
Solution
Cipla Limited L-139 to
L-146, Verna Goa,
Oral PET bottle; 100ml;
Lamivudine (3TC) 10 mg / ml Cipla Ltd. A-B Yes Indore, SEZ, India
Solution HDPE bottle 240ml
Pithampur, Dist Dhar
(M.P.)
Unit-III 22-110,
Industrial
Oral
Lamivudine (3TC) 10 mg / ml Hetero labs limited B Yes Development Area India HDPE Bottle 240ml
Solution
Jeedimetla,
Hyderabad
Macleods
Oral Solan, Himachal
Lamivudine (3TC) 10 mg / ml Pharmaceuticals A Yes India HDPE Bottle 240ml
Solution Pradesh, India
Limited
57 Lamivudine (3TC) 30mg Tablet Cipla Ltd. A Yes Goa India HDPE Bottle 60
PVC/PVdC/ 10
Lamivudine (3TC) 30mg Tablet Microlabs Ltd A Yes Verna, Goa India Alu blister ; 60,100,500,
HDPE bottle 1000
Sun
Paonta Sahib,
58 Lamivudine (3TC) 30mg Disp Tablet Pharmaceutical A Yes India HDPE Bottle 60
Himachal Pradesh
Industries Ltd
Tablet Film Glaxo SmithKline Blister;
58 Lamivudine (3TC) 100 mg B Yes Ware, Hartfordshire UK 28, 84
coated Ltd. Bottle
Macleods HDPE
Tablet Film Kachigam, Daman 60;
60 Lamivudine (3TC) 150 mg Pharmaceuticals A-B Yes India Bottle;
Coated Baddi, H.P. 6*10
Limited Blister
WHO
Global
o Standard
SRA
36/7,
HDPE
Film coated Strides Arcolab Suragajakkanahalli 30, 60;
Lamivudine (3TC) 150 mg A-B Yes India bottle;
Tablet Limited Indlavadi cross Anekal 10
Blister
Taluk Bangalore
Metallised
Aspen Pharmacare Port Elizabeth,
Lamivudine (3TC) 150 mg Tablet A Yes South Africa lay flat pack, 60
Ltd. Korsten
PP bottle
Goa;
Lamivudine (3TC) 150 mg Tablet Cipla Ltd. A Yes Meditab Specialities India HDPE Bottle 30, 60
Ltd, Goa
Unit III Survey No.

313, Bachupally,
Quthubullapur
HDPE
Aurobindo Pharma Mandal, Hyderabad, 60;
Lamivudine (3TC) 150 mg Tablet B Yes India Bottle;
Ltd Andhra Pradesh, 10
Blister
Unit-VII (SEZ),
Mahaboob Nagar

Ltd, Ware,
Hertfordshire, UK;
Tablet Film GSK, Poznan UK
Lamivudine (3TC) 150 mg ViiV HealthCare A-B Yes HDPE bottle 60
coated (packaging and South Africa
release), Poland
Pharmacare (ASPEN),
Port Elizabeth,
Hyderabad, Andhra
Pradesh, India;
India HDPE Bottle 60, 600
Lamivudine (3TC) 150 mg Tablet Hetero labs limited A-B Yes STADA-VN Joint
Vietnam Blister, 10;
Venture Co, Ltd,
Duong Province,
Vietnam
WHO
Global
o Standard
SRA
Alu/PVC/Pv
6x10
Lamivudine (3TC) 150 mg Tablet Microlabs Ltd A HA644 Verna, Goa India dC blister
60
HDPE Bottle
Sun HDPE
Paonta Sahib, 60,
Lamivudine (3TC) 150 mg Tablet Pharmaceutical A-B Yes India Bottle,
Himachal Pradesh 10
Alkem Laboratories
Lamivudine (3TC) 150 mg Tablet B Yes Amaliya, Daman India HDPE Bottle 60
Ltd
HDPE bottle 30, 60, 90
Lamivudine (3TC) 150 mg Tablet Microlabs Ltd B Yes Verna, Goa India
Blister 10
Centaur Biotech Park
Lamivudine (3TC) 150 mg Tablet Pharmaceutical B Yes Hinjewadi Phase II India HDPE bottle 60
Private Limited Pune, Maharashtra
HDPE
61 Lamivudine (3TC) 300 mg Tablet A -B Yes India Bottle;
Ltd Maharashtra 6*10
Blister
Unit III Survey No.
313, Bachupally, HDPE
Aurobindo Pharma 30;
Lamivudine (3TC) 300 mg Tablet B Yes Quthubullapur India Bottle;
Ltd 10
Mandal, Hyderabad, Blister
Andhra Pradesh,
Lamivudine (3TC) 300 mg Tablet Cipla Ltd. A Yes Goa India HDPE Bottle 30,60
36/7,
Film coated Strides Arcolab Suragajakkanahalli HDPE
Lamivudine (3TC) 300 mg B Yes India 30; 60
Tablet Limited Indlavadi cross Anekal Bottle,
Taluk Bangalore
Macleods HDPE
30;
Lamivudine (3TC) 300 mg Tablet Pharmaceuticals A-B Yes Kachigam, Daman India Bottle;
3* 10; 6*10
Limited Blister
WHO
Global
o Standard
SRA
High density
Glaxo SmithKline polyethylene
Lamivudine (3TC) 300 mg Tablet B Yes Greenford, Middlesex UK 30
Ltd. (HDPE)
bottle
Unit III 22-110, I.D.A.,

Lamivudine (3TC) 300 mg Tablet Hetero labs limited B Yes Jeedimetla Jeedimeta, India HDPE bottle 30, 600
Hyderabad
HDPE bottle 30, 60, 90

Lamivudine (3TC) 300 mg Tablet Microlabs Ltd B Yes Verna, Goa India
Blister 10
Lamivudine + Nevirapine 30 mg + 50 mg + Dispersible Plot No. L-139, L146-
62 Cipla Ltd. A-B Yes India HDPE bottle 60, 1000
+ Stavudine 6 mg Tablet Verna, Goa
Lamivudine + Nevirapine 60 mg + 100 mg Dispersible Plot No. L-139, L146-
63 Cipla Ltd. A-B Yes India HDPE Bottle 60, 1000
+ Stavudine + 12 mg Tablet Verna, Goa
Kurkumbh India ,
Patalganga, India;
Plot
136,146(UNITIII&IV),
L147,L147-1 UNIT-VII-
Lamivudine + Nevirapine 150 mg +200 30; 60;
64 Tablet Cipla Ltd. A-B Yes Goa,; India HDPE bottle
+ Stavudine mg+ 30 mg 1000
Himachal Pradesh,
India;
Cipla Ltd Indore, SEZ,
(M.P.), India
Emcure
Lamivudine + Nevirapine 150 mg +200
Tablet Pharmaceuticals B Yes Hinjwadi, Pune India HDPE bottle 60
+ Stavudine mg+ 30 mg
Limited
Hyderabad, Andhra
Lamivudine + Nevirapine 150 mg +200 Pradesh, India;
Tablet Hetero labs limited A-B Yes India HDPE Bottle 60, 100, 500
+ Stavudine mg+ 30 mg Unit-V, Mahaboob
Nagar, Andhra
Pradesh, India
Lamivudine + Nevirapine 150 mg +200 Mylan Laboratories Sinnar,Nashik,
Tablet A Yes India HDPE Bottle 60
+ Stavudine mg+ 30 mg Ltd Maharashtra
WHO
Global
o Standard
SRA
Macleods
Tablet Pharmaceuticals B Yes Kachigam, Daman India HDPE Bottle 60
Limited
36/7,
Lamivudine + Nevirapine 150 mg +200 Strides Arcolab Suragajakkanahalli
Tablet B Yes India HDPE Bottle 60
+ Stavudine mg+ 30 mg Limited Indlavadi cross Anekal
Taluk Bangalore
Tablet Pharmacare Ltd. B Yes Strides Ltd, Banglore India HDPE Bottle 60
Sinnar, Nashik
Lamivudine + Nevirapine 30mg+ 50mg Dispersible Mylan Laboratories
65 A -B Yes India; India HDPE Bottle 60
+ Zidovudine +60mg Tablet Ltd
Waluj, Aurangabad,
Maharashtra, India
36/7,
Tablet for Suragajakkanahalli,
Lamivudine + Nevirapine 30mg+ 50mg Strides Arcolab
Oral A-B Yes Indlavadi cross, India HDPE Bottle 60
+ Zidovudine +60mg Limited
Suspension Anekal Taluk,
Bangalore
Plot No. L-147, L147-1
Tablet for (Unit VII), Verna
Lamivudine + Nevirapine 30mg+ 50mg
Oral Cipla Ltd. B Yes Industrial Estate, India HDPE Bottle 60, 1000
+ Zidovudine +60mg
Suspension Verna Salcette Goa,
403 722
Sinnar Nashik,
Maharastra;
Waluj, Aurangabad,
Maharashtra,
HDPE bottle
India; Mission
Lamivudine + Nevirapine 150 mg + 200 mg Mylan Laboratories ; 60;
66 Tablet A-B Yes Vivacare Limited, India
+ Zidovudine + 300 mg Ltd PVC/PVdC/ 6 X 10;
Pithampur, Dhar,
Alu blister;
M.P., India; Shasun
Pharmaceutical Ltd,
Periyakalapet,
Puducherry
WHO
Global
o Standard
SRA
Cipla Ltd, Goa,UNIT-
III & UNIT-IV India;
Cipla Ltd, Indore,
SEZ; Mylan
Pithambur, Dhar Dist.,
Lamivudine + Nevirapine 150 mg + 200 mg Madhya Pradesh; India
Tablet Cipla Ltd. A-B Yes HDPE bottle 30, 60, 500
+ Zidovudine + 300 mg Quality Chemical Uganda
Industries Ltd,
Kampala, Uganda;
Cipla Ltd Baddi,
Himachal Pradesh,
India
Hyderabad, Andhra
Lamivudine + Nevirapine 150 mg + 200 mg Pradesh, India; Blister; 10;
Tablet Hetero labs limited A-B Yes India
+ Zidovudine + 300 mg Unit-V, Mahaboob HDPE bottle 60, 100, 500
Nagar, Andhra
Pradesh
Paonta Sahib,
Sun Himachal Pradesh; HDPE Bottle
Lamivudine + Nevirapine 150 mg + 200 mg 60,
Tablet Pharmaceutical A Yes Shasun India /PVdc/PVC
+ Zidovudine + 300 mg 10
Industries Ltd Pharmaceutical Ltd, blister
Puducherry,
Macleods
Lamivudine + Nevirapine 150 mg + 200 mg Kachigam, Daman
Tablet Pharmaceuticals A-B Yes India HDPE Bottle 60
+ Zidovudine + 300 mg Baddi, H.P.
Limited

Quthubullapur
HDPE
Lamivudine + Nevirapine 150 mg + 200 mg Aurobindo Pharma Mandal Hyderabad, 60;
Tablet B Yes India Bottle;
+ Zidovudine + 300 mg Ltd Andhra Pradesh 10
Blister
Unit-VII (SEZ),
Mahaboob Nagar
WHO
Global
o Standard
SRA
36/7,
Lamivudine + Nevirapine 150 mg + 200 mg Film coated Strides Arcolab Suragajakkanahalli
A-B Yes India HDPE bottle 60
+ Zidovudine + 300 mg Tablet Limited Indlavadi cross Anekal
Taluk Bangalore
HDPE
Tablet for 30, 60,
L-139 to L-146, UNIT- bottle;
67 Lamivudine + Stavudine 30 mg + 6mg Oral Cipla Ltd. A-B Yes India 1000;
III & VI, Verna Goa Blister
Suspension 14
HDPE
Tablet for 30, 60,
L-139 to L-146, UNIT- bottle;
68 Lamivudine + Stavudine 60 mg + 12mg Oral Cipla Ltd. A-B Yes India 1000;
III & VI, Verna Goa Blister
Suspension 14
Patalganga,
60, 30,
69 Lamivudine + Stavudine 150 mg + 30 mg Tablet Cipla Ltd. A-B Yes L-139 to L-146, UNIT- India HDPE bottle
1000
III & VI, Verna Goa
36/7,
Strides Arcolab Suragajakkanahalli
Lamivudine + Stavudine 150 mg + 30 mg Tablet A Yes India HDPE Bottle 60
Limited Indlavadi cross Anekal
Taluk Bangalore
Macleods
Lamivudine + Stavudine 150 mg + 30 mg Tablet Pharmaceuticals B Yes Kachigam, Daman India HDPE Bottle 60
Limited
Unit III 22-110, I.D.A.,
30, 60, 100,
Lamivudine + Stavudine 150 mg + 30 mg Tablet Hetero labs limited B Yes Jeedimetla Jeedimeta, India HDPE Bottle
500
Hyderabad
Lamivudine + Stavudine 150 mg + 30 mg Tablet Pharmacare Ltd. B Yes Strides Ltd, Banglore India HDPE Bottle 60
WHO
Global
o Standard
SRA
Unit-III, 22-110,
Industrial
Development Area,
Jeedimetla,
Lamivudine + Tenofovir 300 mg + 300 30, 60, 100,
70 Tablet Hetero labs limited A-B Yes Hyderabad; India HDPE Bottle
disoproxil fumarate mg 500
and
Unit V Mahaboob
Nagar Dist, Andhra
Pradesh.
Lamivudine + Tenofovir 300 mg + 300 Mylan Laboratories Sinnar,Nashik,
Tablet A-B Yes India HDPE bottle 30, 100
disoproxil fumarate mg Ltd Maharashtra
Unit-VII (SEZ),
Lamivudine + Tenofovir 300 mg + 300 Aurobindo Pharma
Tablet B Yes Mahaboob Nagar India HDPE bottle 30
disoproxil fumarate mg Ltd
D-7 MIDC Kurkumbh;

Quality 30, 500
Lamivudine + Tenofovir 300 mg + 300 HDPE Bottle
Tablet Cipla Ltd. A- B Yes Chemical Industries India
disoproxil fumarate mg Blister
Ltd, Kampala, 10
Uganda
Sun
Lamivudine + Tenofovir 300 mg + 300 Shasun
Tablet Pharmaceutical A-B Yes India HDPE Bottle 30
disoproxil fumarate mg Pharmaceuticals Ltd
Industries Ltd
Macleods Kachigam- Daman
Lamivudine + Tenofovir 300 mg + 300 HDPE Bottle 30
Tablet Pharmaceuticals A-B Yes Baddi- Himachal India
disoproxil fumarate mg Blister 10
Limited Pradesh
Lamivudine + Tenofovir 300 mg + 300
Tablet Microlabs Ltd A Yes Verna, Goa India HDPE Bottle 30, 100
disoproxil fumarate mg
Alu/Alu (1+1+1) per
Capsules+ Sinnar,Nashik,
[Lamivudine+Tenofovir] [300mg+300mg] Mylan Laboratories Blister per coblister; 3
71 Tablets+ A Yes Maharashtra, India
+Atazanavir+ Ritonavir +300mg+100mg Ltd co packed blisters in a
Tablets
blister carton
Sinnar,Nashik, Alu/Alu (1+2) per
Tablets
[Lamivudine+Tenofovir] [300mg + Mylan Laboratories Maharashtra Blister; blister;
72 ( co- A- B Yes India
+Nevirapine 300mg] +200mg Ltd Village Theda, Post Blister in 3 blisters in
packaged)
Office Lodhimajra Carton a carton
WHO
Global
o Standard
SRA
1 Blister
Aurobindo Pharma
[Lamivudine+Tenofovir contains(4+
(300+300mg) + Co-Blistered Aurobindo Pharma Limited, Unit VII
disoproxil fumarate] + B Yes India Blister 2)
200mg tablets Ltd (SEZ)
Nevirapine 15 blisters in
Andhra Pradesh
a box.
Hetero Labs Limited 1 Blister
[Lamivudine+Tenofovir Unit III contains(1+
(300+300mg) + Co-Blistered
disoproxil fumarate] + Hetero labs limited B Yes 22-110, I D A, India Co Blister 2)
200mg tablets
Nevirapine Jeedimetla, 10 blisters
Hyderabad in a box.
one carton
contains one
[Lamivudine+Tenofovir Macleods
(300+300mg) + Co-Blistered Alu/Alu blister of
disoproxil fumarate] + Pharmaceuticals A Yes Kachigam, Damam India
200mg tablets blister one
Nevirapine Limited
lamivudine/
TDF tablet
Sinnar-Nashik,
Lamivudine + Dispersible Mylan Laboratories
73 30 mg + 60 mg A -B Yes Maharashtra India HDPE 60
Zidovudine Tablet Ltd
Waluj, Aurangabad
Sun
Lamivudine + Dispersible Paonta Sahib,
30 mg + 60 mg Pharmaceutical A Yes India HDPE Bottle 60
Zidovudine Tablet Himachal Pradesh
Industries Ltd
Tablet for HDPE
Lamivudine +
30 mg + 60 mg Oral Cipla Ltd. B Yes Unit VII, Verna, Goa. India bottle; 60
Zidovudine
Suspension Blister
Sinnar-Nashik,
Lamivudine + Mylan Laboratories
74 30 mg + 60 mg Tablet A -B Yes Maharashtra India HDPE 60
Zidovudine Ltd
Waluj, Aurangabad
UNIT III, Survey No.
313 and 314,
HDPE
Lamivudine + Aurobindo Pharma Bachupally 60, 1000;
30 mg + 60 mg Tablet B Yes India Bottle;
Zidovudine Ltd Quthubullapur 10
Blister
Mandal, Hyderabad,
Andhra Pradesh
HDPE
Lamivudine + L-139 to L-146, UNIT 60; 1000
30 mg + 60 mg Tablet Cipla Ltd. B Yes India bottle;
Zidovudine III-Verna Goa, 10
Blister
WHO
Global
o Standard
SRA
6 x 10;
PVC/PVdC/
Lamivudine +
30 mg + 60 mg Tablet Microlabs Ltd A Yes Verna, Goa India Alu blister
Zidovudine 60, 100,
HDPE
1000
Unit III Survey,
Hyderabad, Andhra HDPE
Lamivudine + Aurobindo Pharma 60;
75 150 mg + 300 mg Tablet B Yes Pradesh India bottle;
Zidovudine Ltd 10
Unit-VII (SEZ), Blister
Andhra Pradesh
Plot No. L-147, L147-1,
Verna Goa,
Indore, SEZ,
(M.P.), India;
Quality Chemical
HDPE bottle
Lamivudine + Industries Ltd, India 60, 1000 ;
150 mg + 300 mg Tablet Cipla Ltd. A-B Yes ;
Zidovudine Kampala, Uganda; Uganda 10, 14
Cipla Ltd Baddi,
Blister
Himachal Pradesh,
India
Meditab Specialities Pvt
Ltd, Kundaim,
Goa
Unit-III, 22-110,
Lamivudine + Hetero Labs Jeedimetla, HDPE bottle 60, 500
150 mg + 300 mg Tablet A-B Yes India
Zidovudine Limited Hyderabad Blister; 10;
Unit-V, Hyderabad
HDPE bottle
Lamivudine + Mylan Laboratories Sinnar,Nashik, 60;
150 mg + 300 mg Tablet A-B Yes India ;
Zidovudine Ltd Maharashtra 10
Blister
Ltd, Ware,
Lamivudine + Hertfordshire, UK; Bottle 60,
150 mg + 300 mg Tablet ViiV HealthCare A Yes UK
Zidovudine GSK, Poznan Blister, 60
(packaging and
release), Poland
WHO
Global
o Standard
SRA
HDPE
bottle;
Sun
Lamivudine + Paonta Sahib, Alu/PA/PVC 60;
150 mg + 300 mg Tablet Pharmaceutical A Yes India
Zidovudine Himachal Pradesh Blister; 10
Industries Ltd
PVdC/PVC
blister
36/7,
Lamivudine + Film coated Strides Arcolab Suragajakkanahalli
150 mg + 300 mg A-B Yes India HDPE bottle 60
Zidovudine Tablet Limited Indlavadi cross Anekal
Taluk Bangalore
Lamivudine + Universal
150 mg + 300 mg Tablet A Yes Kikuyu Kenya HDPE 60
Zidovudine Corporation
HDPE
Lamivudine + bottle; 30, 60, 90;
150 mg + 300 mg Tablet Microlabs Ltd A Yes Verna, Goa India
Zidovudine PVDC/PVC/ 10*10;
Alu blister;
Lamivudine + Port Elizabeth,
150 mg + 300 mg Tablet Pharmacare Ltd. B Yes South Africa Blister 60
Zidovudine Korsten
Macleods HDPE
Lamivudine + Kachigam, Daman 60;
150 mg + 300 mg Tablet Pharmaceuticals A -B Yes India Bottle;
Zidovudine Baddi, H.P. 6*10, 12*10
Limited Blister
Emcure
Lamivudine + HDPE bottle 60
150 mg + 300 mg Tablet Pharmaceuticals B Yes Hinjwadi, Pune India
Zidovudine Blister 10
Limited
Dhar, Pithampur,
Lamivudine +
150 mg + 300 mg Tablet Lupin A Yes Madhya Pradesh; India HDPE bottle 60
Zidovudine
Verna, Salcette Goa,
10 doses on
Unit III 22 - 110, one blister
[Lamivudine + Industrial PVC/Alu sheet and 6
Co packaged
76 Zidovudine] + [150mg+300mg] Hetero labs limited B Yes development Area, India Blister; sheets
Tablet
Nevirapine +200mg Jeedimetla, Blister included in
Hyderabad the carton
WHO
Global
o Standard
SRA
Each card
contains 6
[Lamivudine + Fairclough Road, lamivudine /
Co packaged Blister
77 Zidovudine] + [150mg+300mg] Pharmacare Ltd. B Yes Korsten, Port South Africa zidovudine
Tablet cards.
Nevirapine +200mg Elizabeth, 6020, tablets and 6
nevirapine
tablets.
36/7,
[Lamivudine +
Co packaged Strides Arcolab Suragajakkanahalli
Zidovudine] + [150mg+300mg] B Yes India HDPE Bottle (60)+60
Nevirapine +200mg
Taluk Bangalore
Lopinavir (LPV) + (80 mg + 20 mg) Oral Abbott 60ml,
78 A -B Yes Queensborough, Kent, UK PET bottle
Ritonavir (RTV) / ml Solution Laboratories Ltd. 160ml
Lopinavir (LPV) + (80 mg + 20 mg) Oral Abbott
B Yes North Chicago Illinois,USA PET bottle 160ml
Ritonavir (RTV) / ml Solution Laboratories Ltd.
Plot No. L-139, S-103 Amber
Lopinavir (LPV) + (80 mg + 20 mg) Oral & M-62, Verna coloured
Cipla Ltd. B Yes India 160ml
Ritonavir (RTV) / ml Solution Industrial Estate, PET Bottle
Verna Salcette, Goa,
Plot L147 to L-147-1,
Pellets in Verna Industrial
79 Lopinavir+Ritonavir 40mg/10mg Cipla Ltd. B Yes India HDPE Bottle 120
Capsule Estate,
Verna, Goa
Lopinavir (LPV) + Abbott

80 100 mg + 25 mg Tablet A Yes Ludwigshafen Germany HDPE bottle 60
Ritonavir (RTV) Laboratories Ltd.

100 mg + 25 mg Tablet B Yes North Chicago Illinois,USA HDPE bottle 60
Unit-8, Andhra
Lopinavir (LPV) + Mylan Laboratories
100 mg + 25 mg Tablet A Yes Pradesh (for premix), India HDPE Bottle 120
Ritonavir (RTV) Ltd
India
WHO
Global
o Standard
SRA
Unit III Survey No.
313 and 314
HDPE
Lopinavir (LPV) + Aurobindo Pharma Bachupally 60;
Ritonavir (RTV) Ltd Quthubullapur 6*10
Blister
Mandal, Hyderabad
Andhra Pradesh
Macleods
Lopinavir (LPV) + Solan, Himachal
100 mg + 25 mg Tablet Pharmaceuticals A Yes India HDPE bottle 60
Ritonavir (RTV) Pradesh
Limited
Hetero labs Limited
Lopinavir (LPV) + (Unit-III),
100 mg + 25 mg Tablet Hetero labs limited B India HDPE bottle 120
Ritonavir (RTV) Jeedimetla,Hyderabad-
500055
Lopinavir (LPV) + 133.3 mg + 33.3 Abbott
81 Capsule A Yes RP Scherer, Florida, USA HDPE bottle 90
Ritonavir (RTV) mg Laboratories Ltd.
Bottle
Lopinavir (LPV) + 133.3 mg + 33.3 Abbott
Capsule Soft B Yes Queenborough, Kent UK (HDPE) 90, 180
Ritonavir (RTV) mg Laboratories Ltd.
Bottle (PVC)
HDPE
Lopinavir (LPV) + Mylan Laboratories Sinnar,Nashik, 120;
82 200 mg + 50 mg Tablet A-B Yes India Bottle;
Ritonavir (RTV) Ltd Maharashtra 6. 12
Blister
200 mg + 50 mg Tablet A Yes Ludwigshafen, Germany HDPE bottle 120
Unit III Survey No.
313 and 314
HDPE
Lopinavir (LPV) + Aurobindo Pharma Bachupally 120;
Ritonavir (RTV) Ltd Quthubullapur 6*10
Blister
Mandal, Hyderabad
Andhra Pradesh
Lopinavir (LPV) + A-42, MIDC HDPE Bottle 120,

200 mg + 50 mg Tablet Cipla Ltd. B Yes India
Ritonavir (RTV) Patalganga Blister 10
Unit III 22 - 110, HDPE

Industrial Alu/Alu
Lopinavir (LPV) + 60, 120
200 mg + 50 mg Tablet Hetero labs limited A-B Yes development Area, India Blister
Ritonavir (RTV) 10
Jeedimetla, Alu/PVC/PV
Hyderabad dC blister
WHO
Global
o Standard
SRA
Macleods
Lopinavir (LPV) + Solan, Himachal
200 mg + 50 mg Tablet Pharmaceuticals A Yes India HDPE bottle 120
Ritonavir (RTV) Pradesh
Limited
HDPE
Oral Boehringer 240ml +
83 Nevirapine (NVP) 10 mg / ml A Yes Roxane, Columbus, USA bottle+
Suspension Ingelheim 5ml
syringe
Cipla Ltd, Goa, India;

Amber
Meditab Specialties
coloured
Pvt Ltd, Maharashtra, 100ml, 240
Oral PET Bottle
Nevirapine (NVP) 10 mg / ml Cipla Ltd. A Yes India; India
Suspension Amber
Indore, SEZ, 25ml, 10ml
coloured
glass bottle
(M.P.)
Unit III Survey No.
313 and 314
Oral Aurobindo Pharma Bachupally 240ml
Nevirapine (NVP) 50 mg /5 ml B Yes India HDPE bottle
Suspension Ltd Quthubullapur 100ml
Mandal, Hyderabad
Andhra Pradesh
Plot No: S-155 to S-

159, Phase III, HDPE bottle 30,60,90
84 Nevirapine 20mg Tablet Microlabs Ltd A Yes Verna Industrial India
Estate, Verna, Goa- Blister 10
403722
Unit III Survey No.

313 and 314
Tablet
Aurobindo Pharma Bachupally
85 Nevirapine (NVP) 50mg for Oral B Yes India HDPE bottle 30, 180
Ltd Quthubullapur
Suspension
Mandal, Hyderabad
Andhra Pradesh
Tablet 60, 1000
A-42, MIDC, HDPE bottle
Nevirapine (NVP) 50mg for Oral Cipla Ltd. A-B Yes India
Patalganga, Blister
Suspension 10
Sun
Dispersible Paonta Sahib,
Nevirapine (NVP) 50mg Pharmaceutical A Yes India HDPE bottle 60
tablet Himachal Pradesh,
Industries Ltd
WHO
Global
o Standard
SRA
HDPE bottle 30,60,90
159, Phase III,
86 Nevirapine 50mg Tablet Microlabs Ltd A Yes India
Verna Industrial
Blister 10
Estate, Verna, Goa-
Tablet 60, 1000
A-42, MIDC, HDPE bottle
87 Nevirapine (NVP) 100mg for Oral Cipla Ltd. A-B Yes India
Patalganga, Blister
Suspension 10
Sun
Dispersible Paonta Sahib,
Nevirapine (NVP) 100mg Pharmaceutical A Yes India HDPE bottle 60
tablet Himachal Pradesh,
Industries Ltd
HDPE bottle 30,60,90
159, Phase III,
88 Nevirapine 100mg Tablet Microlabs Ltd A Yes India
Verna Industrial
Blister 10
Estate, Verna, Goa-
Unit III Survey No.
313, Bachupally,
Quthubullapur
HDPE
Aurobindo Pharma Mandal, Hyderabad, 60;
89 Nevirapine (NVP) 200 mg Tablet B Yes India bottle;
Blister
Unit-VII (SEZ),
Mahaboob Nagar
Plot
136,146(UNITIII&IV),
L147,L147-1 UNIT-VII-
Goa;
HDPE
Meditab Specialties India 60, 1000 ;
Nevirapine (NVP) 200 mg Tablet Cipla Ltd. A-B Yes Bottle;
Pvt Ltd, Kundaim, Uganda 10
Blister
Goa,
Quality Chemical
Industries Ltd,
Kampala
60,
HDPE bottle 100,500,
Nevirapine (NVP) 200 mg Tablet Hetero labs limited A-B Yes Hyderabad, Andhra India
Blister; 1000
Pradesh
10;
HDPE
Nevirapine (NVP) 200 mg Tablet A-B Yes India bottle;
Ltd Maharashtra 10
Blister
WHO
Global
o Standard
SRA
Sun HDPE bottle
Paonta Sahib, 60, 1000;
Nevirapine (NVP) 200 mg Tablet Pharmaceutical A-B Yes India ;
Himachal Pradesh 10
36/7,
Strides Arcolab Suragajakkanahalli HDPE
Nevirapine (NVP) 200 mg Tablet A-B Yes India 60
Limited Indlavadi cross Anekal Container
Taluk Bangalore
Nevirapine (NVP) 200 mg Tablet A Yes South Africa Blister 10
Ltd. Korsten
Boehringer Ingelheim
Pharma GmbH & Co,
Boehringer Germany
Nevirapine (NVP) 200 mg Tablet A Yes KG, Ingelheim; Blister 60
Ingelheim Greece
Boehringer Ingelheim
Ellas A.E., Koropi
HDPE
Macleods
bottle; 60;
Nevirapine (NVP) 200 mg Tablet Pharmaceuticals A- B Yes Kachigam, Daman India
PVdC/PVC/ 6*10, 12*10
Limited
Alu Blister
Emcure HDPE 60;
Nevirapine (NVP) 200 mg Tablet Pharmaceuticals B Yes Hinjwadi, Pune India Bottle;
Limited Blister 10
Huahai Xunqiao, Linhai,
Nevirapine (NVP) 200 mg Tablet B Yes China HDPE Bottle 60
Pharmaceutical Zhejiang
HDPE 60
Nevirapine (NVP) 200 mg Tablet Microlabs Ltd A-B Yes Verna, Goa India
Blister 10
ScieGen
Nevirapine (NVP) 200 mg Tablet B Yes USA HDPE Bottle 30, 500
Pharmaceuticals
L138-147 L150 S103- HDPE 30;
90 Nevirapine (NVP) 400 mg Tablet Cipla Ltd. B Yes 105 S107-112 M61-63 India Bottle;
Verna, Salcette, GOA Blister 10
Elkton USA
Zhejiang Huahai China
91 Raltegravir 400mg Tablet Merck & Co, USA B Yes Bottle 60
Singapore Singapore
Harleem Netherlands
WHO
Global
o Standard
SRA
Unit III 22 - 110,
Industrial 60, 120
Bottle
Raltegravir 400mg Tablet Hetero labs limited B Yes development Area, India 10'sx10
Blister
Jeedimetla, 10'sx14
Hyderabad
Elkton USA
Chewable
92 Raltegravir 100mg Merck & Co, USA B Yes Bottle 60
tablet
Elkton USA
Chewable
93 Raltegravir 25mg Merck & Co, USA B Yes Bottle 60
tablet
Oral Abbott
94 Ritonavir (RTV) 80 mg / ml A Yes Queenborough, Kent UK PET bottle 90ml
Solution Laboratories Ltd.
A-42, MIDC,
95 Ritonavir (RTV) 25 mg Tablet Cipla Ltd. B Yes India HDPE Bottle 60
Patalganga,
Mylan Laboratories Sinnar, Nashik,
Ritonavir (RTV) 25 mg Tablet A Yes India HDPE Bottle 30
Ltd Maharashtra
A-42, MIDC,
96 Ritonavir (RTV) 50 mg Tablet Cipla Ltd. B Yes India HDPE Bottle 60
Patalganga,
HDPE
Abbott RP Scherer, Florida, USA 84,
97 Ritonavir (RTV) 100 mg Capsule A Yes bottle;
Laboratories Ltd. Beinheim France
Mylan Laboratories Sinnar,Nashik, HDPE
Ritonavir (RTV) 100 mg Tablet A Yes India 30, 120
Ltd Maharashtra Bottle
Abbott
Ritonavir (RTV) 100 mg Tablet A Yes Luwigshafen, Germany HDPE Bottle 30, 60
Laboratories Ltd.
A-42, MIDC,
Ritonavir (RTV) 100 mg Tablet Cipla Ltd. A-B Yes India HDPE Bottle 30
Patalganga,
F.Hoffman-La RP Scherer, Baden; Germany; 180;
98 Saquinavir 200mg Capsule A Yes HDPE bottle
Roche Basel Switzerland 270
F.Hoffman-La
99 Saquinavir 500mg Tablet A Yes Madrid Spain HDPE Bottle 120
Roche
Powder for
Bristol-Myers
100 Stavudine (d4T) 1 mg / ml Oral A Yes Evansville, Indiana, USA HDPE bottle 200ml
Squibb
Solution
WHO
Global
o Standard
SRA
Powder for
Bristol-Myers HDPE
Stavudine (d4T) 1 mg / ml Oral B Yes Meymac France 200ml
Squibb Container
Solution
Powder for
M-61, M-62, M-63,
Stavudine (d4T) 1 mg / ml Oral Cipla Ltd. A -B Yes India HDPE bottle 200ml
Verna Goa
Solution
Emcure
Pharmaceuticals USA,
New
Jersey (manufacturing
and primary
Bristol-Myers packaging), USA. USA HDPE bottle 60
101 Stavudine (d4T) 15 mg Capsule A Yes
Squibb Bristol-Myers Squibb, Blister 14
Anagni (Frosinone)
(secondary
packaging, testing and
batch release),
Italy.
Aurobindo Pharma
Stavudine (d4T) 15 mg Capsule B Yes Quthubullapur India HDPE bottle 60
Ltd
Mandal Hyderabad,
Andhra Pradesh
Unit-III, 22-110,
Industrial
60, 100,
Stavudine (d4T) 15 mg Capsule Hetero labs limited B Yes Development Area, India HDPE Bottle
1000
Jeedimetla,
Hyderabad
102 Stavudine (d4T) 20 mg Capsule A Yes South Africa Glass bottle 60
Ltd. Korsten
WHO
Global
o Standard
SRA
Emcure
New
and primary
Stavudine (d4T) 20 mg Capsule A Yes
Anagni (Frosinone)
(secondary
batch release),
Italy.
Aurobindo Pharma
Ltd
Mandal Hyderabad,
Andhra Pradesh
Unit-III, 22-110,
Industrial
60, 100,
Stavudine (d4T) 20 mg Capsule Hetero labs limited B Yes Development Area, India HDPE Bottle
1000
Jeedimetla,
Hyderabad
103 Stavudine (d4T) 30 mg Capsule A Yes South Africa Glass bottle 60
Ltd. Korsten
Macleods
Stavudine (d4T) 30 mg Capsule Pharmaceuticals A Yes Kachigam, Daman India HDPE Bottle 60
Limited
Aurobindo Pharma
Ltd
Mandal Hyderabad,
Andhra Pradesh
WHO
Global
o Standard
SRA
Emcure
New
and primary
Stavudine (d4T) 30 mg Capsule A-B Yes
Anagni (Frosinone)
(secondary
batch release),
Italy.
HDPE
Stavudine (d4T) 30 mg Capsule A-B Yes India Bottle;
Ltd Maharashtra 10
Blister
36/7,
Strides Arcolab Suragajakkanahalli
Stavudine (d4T) 30 mg Capsule A-B Yes India HDPE bottle 60
Limited Indlavadi cross Anekal
Taluk Bangalore
Unit-III, 22-110,
Industrial
Stavudine (d4T) 30 mg Capsule Hetero labs limited B Yes Development Area, India HDPE Bottle 60, 100, 500
Jeedimetla,
Hyderabad
40mg/gm( Eq to
Tenofovir Disoproxil 33mg/gm of Gilead Sciences, Takeda GmbH Germany
104 granule B Yes HDPE bottle 60g
Fumarate Tenofovir Inc. Country Cork Ireland
Disoproxil
Patheon Inc.
Tenofovir Disoproxil Tablet Film Gilead Sciences, Mississauga, Ontario Canada HDPE
105 300mg B Yes 30
Fumarate coated Inc. Nycomed Oranienburg Germany container
GmbH,
Tenofovir Disoproxil Plot No. L-147, L147-1,
300 mg Tablet Cipla Ltd. A-B Yes India HDPE bottle 30, 1000
Fumarate Verna Goa,
WHO
Global
o Standard
SRA
Patheon Inc.,
Mississauga,Ontario,
Canada;
Altana Pharma,
Oranienburg GmbH, Germany
Tenofovir Disoproxil Gilead Sciences,
300 mg Tablet A Yes Oranienburg, Canada HDPE bottle 30
Fumarate Inc.
Germany; South Africa
Aspen Pharmacare,
OSD Facility, Korsten,
Port Elizabeth, South
Africa
Sun
Tenofovir Disoproxil Paonta Shahib,
300mg Tablet Pharmaceutical A Yes India HDPE Bottle 30
Fumarate Himachal Pradesh
Industries Ltd
Tenofovir Disoproxil Gilead Sciences, Granta Park Abington, HDPE bottle
300 mg Tablet B Yes UK 30
Fumarate Inc. Cambridge Blister
HDPE
Tenofovir Disoproxil Mylan Laboratories Sinnar,Nashik, 30,100;
300 mg Tablet A-B Yes India Bottle;
Fumarate Ltd Maharashtra 2*10
Blister
36/7,
Tenofovir Disoproxil Strides Arcolab Suragajakkanahalli HDPE Bottle 30
300 mg Tablet A-B Yes India
Fumarate Limited Indlavadi cross Anekal Blister 10
Taluk Bangalore

313 & 314, Bachupally,
Quthubullapur
Tenofovir Disoproxil Aurobindo Pharma Mandal Hyderabad,
300 mg Tablet B Yes India HDPE bottle 30,
Fumarate Ltd Andhra Pradesh
Unit-VII (SEZ),
Mahaboob Nagar
WHO
Global
o Standard
SRA
Unit III 22-110
Industrial
Tenofovir Disoproxil 30, 60, 100,
300 mg Tablet Hetero labs limited A-B Yes development Area India HDPE Bottle
Fumarate 500, 1000
Jeedimetla,
Hyderabad
(Pty) Ltd, Korsten Port
Tenofovir Disoproxil Elizabeth,
300 mg Tablet Pharmacare Ltd. A HA588 South Africa HDPE Bottle 30
Fumarate South Africa
Macleods
Tenofovir Disoproxil Kachigam, Daman
300 mg Tablet Pharmaceuticals A Yes India HDPE bottle 30,
Fumarate Baddi, H.P.
Limited
PVC/PVdC/ 10x10
106 Zidovudine 60mg Tablet Microlabs Ltd A Yes South Africa India Alu blister 60, 100,
HDPE bottle 500, 1000
Sun
Dispersible Paonta Shahib, HDPE
107 Zidovudine 60mg Pharmaceutical A Yes India 60
Tablet Himachal Pradesh Bottle
Industries Ltd
Infusion Barnard Castle,
108 Zidovudine 10mg/ml ViiV HealthCare A Yes UK Glass vial 20ml
solution County Durham
109 Zidovudine 50mg/5ml Oral solution ViiV HealthCare A Yes Mississauga, Ontario, Canada PET bottle 200ml
PET
Combino Pharm 200ml +
Zidovudine 50mg/5ml Oral solution A Yes Medea, Barcelona Spain bottle+10ml
S.L. 10ml sy
syringe
Zidovudine 50mg/5ml Oral solution Hetero labs limited A Yes Hyderabad, Andhra India HDPE Bottle 240ml
Pradesh, India
Cipla Limited L-139 to
HDPE 100ml,
L-146, Verna Goa,
Zidovudine 50mg/5ml Oral solution Cipla Ltd. A-B Yes India bottle; 240ml
Meditab Specialities
PET Bottle 100ml;
Ltd
WHO
Global
o Standard
SRA
Meditabs
Zidovudine 50mg/5ml Oral solution A Yes Maharastra India PET Bottle 100ml
Specialities Pvt Ltd
Macleods
Solan, Himachal
Zidovudine 50mg/5ml Oral solution Pharmaceuticals A Yes India HDPE Bottle 240ml
Pradesh
Limited
Unit III Survey No. HDPE
313, Bachupally, bottle, with
Aurobindo Pharma
Zidovudine 50mg/5ml Oral solution B Yes Quthubullapur India dose 240ml
Ltd
Mandal, Hyderabad, delivery
Andhra Pradesh device
110 Zidovudine 100mg Tablet A-B Yes India HDPE Bottle 60
Ltd Maharashtra
L138-147 L150 s103-
105 VernaGoa;
111 Zidovudine 100mg Capsules Cipla Ltd. A-B Yes Indore, SEZ, India HDPE Bottle 100; 1000
Pithampur, District
Dhar (M.P.)
Combino Pharm
Zidovudine 100mg Capsules A Yes Medea, Barcelona, Spain Al Strip 100
S.L.
Unit III Survey No 313

and 314, Bachupally
Quthubullapur HDPE 100
Aurobindo Pharma Mandal Hyderabad, bottle;
Zidovudine 100mg Capsules B Yes India
Ltd Anda Pradesh
Unit-VII (SEZ), Blister 10
Mahaboob Nagar
S.C. Europharm, Bottle 100;

Zidovudine 100mg Capsules ViiV HealthCare A Yes Romania
Brasov, Blister 100
S. C. Europharm,
112 Zidovudine 250mg Capsules ViiV HealthCare A Yes , Romania Blister 40
Brasov
HDPE
Combino Pharm
Zidovudine 250mg Capsules A Yes Medea, Barcelona, Spain bottle; 40, 300
S.L.
Blister
WHO
Global
o Standard
SRA
Unit III Survey No.

313, Bachupally,
Quthubullapur,
HDPE
Aurobindo Pharma Hyderabad, Andhra 60;
113 Zidovudine 300mg Tablets B Yes India bottle;
Ltd Pradesh 10
Blister
Unit-VII (SEZ),
Mahaboob Nagar
Unit-III, 22-110,
Industrial
60, 500,
Zidovudine 300mg Tablets Hetero labs limited A-B Yes Development Area, India HDPE bottle
600
Jeedimetla,
Hyderabad
Ltd, Ware,
Hertfordshire, UK; UK Bottle 28
Zidovudine 300mg Tablets ViiV HealthCare A Yes
Glaxo Wellcome SA, Blister 28, 60;
Aranda (packaging
and release), Spain
Sun HDPE
Paonta Sahib, 60;
Zidovudine 300mg Tablets Pharmaceutical A -B Yes India bottle;
Himachal Pradesh, 10, 8
HDPE
Zidovudine 300mg Tablets A -B Yes India bottle;
Ltd Maharashtra 2 x 10
Blister
Combino Pharm Blister ;
Zidovudine 300mg Capsules A Yes Medea, Barcelona, Spain 60, 300
S.L. HDPE bottle
HDPE 30, 60,
Plot No. L-147, L147-1,
Zidovudine 300mg Tablets Cipla Ltd. A-B Yes India Bottle; 1000 ;
Verna Goa,
Blister 10
Sunshine Lake
Zidovudine 300mg Tablets HEC Pharma B Yes Pharma Co. Ltd, China HDPE Bottle 60
GuangDong
WHO
Global
o Standard
SRA
PVDC/PVC/
10;
Zidovudine 300mg Tablets Microlabs Ltd A yes Verna, Goa India Alu blister;
30, 60, 90
HDPE bottle
Macleods PVDC/PVC/
10;
Zidovudine 300mg Tablets Pharmaceuticals A yes Kachigam, Daman India Alu blister;
60
Limited HDPE bottle
End of A or B products List
LIST OF ARV PHARMACEUTICAL PRODUCTS
classified according to the Global Fund Quality Assurance Policy
Edition: Version 131 - 22nd December 2016
List of ERP ( Expert Review Panel) Reviewed Products which are permitted for time limited procurement:
If there is no or only one A or B product available ( supply of the product cannot be done within 90 days after the receipt of the Purchase Order by the manufacturer) ,
grant funds may be used to procure a ERP reviewed product eligible for procurement for limited time (12 months) period. The PR must send the notification form
(available at http://www.theglobalfund.org/en/procurement/quality/?lang=en) to the Global Fund and upon receiving the No Objection letter form the Global Fund,
the procurement can proceed. Please note that the QC test of the selected ERP product will be performed by the Global Fund.
Global Period
International Non- Dosage Supplier/
Ref. Strength/ Dose Fund QA Validity for Manufacturing site Country Material Pack
proprietary name form Manufacturer(s)
No Standard ERP Review
Disp. ERP Plot No A-33, A-2 HDPE

Abacavir (as Sulfate) + Lamivudine 120 mg / 60 mg Cipla Ltd. 17/10/2017 India 60
Tablet Reviewed MIDC Patalganga Bottle
HDPE
Plot No. A-42 (Unit II), 30
ERP Bottle
1 Atazanavir (as sulfate) + Ritonavir 300mg/100mg tablet Cipla 30/10/2016 MIDC, India
Reviewed Alu/Alu
Patalganga 10
Blister
(Unit II), MIDC,
ERP HDPE
2 Darunavir Ethanolate 400mg Tablet Cipla 30/11/2016 Patalganga India 60
Reviewed Bottle
(Unit II), MIDC,
ERP HDPE
3 Darunavir Ethanolate 600mg Tablet Cipla 30/11/2016 Patalganga India 60
Reviewed Bottle
End of ERP Reviewed products list
Edition: Version 131, 22nd December 2016 List of AIDS drugs classified according to the GF QA Policy
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LIST OF ARV PHARMACEUTICAL PRODUCTS

classified according to the Global Fund Quality Assurance Policy

Edition: Version 131 - 22nd December 2016

The pharmaceutical products are classified based on the following information

A classified product - Listed on WHO prequalification list;

The Global Fund list includes the following information:

- "Important Notes" for helpful information;

For more information, please look at:

Produc WHO Pre-

Produc WHO Pre-

Unit III 22-110

Unit III, Survey No.

Dispersible A-33, MIDC

Unit III 22 - 110,

Unit III, Survey No

Unit III, Survey No.

Abacavir (as Sulfate)+ Mylan Laboratories Sinnar,Nashik,

Hetero Labs Limited

Tablets for HDPE

Unit - III Survey No.

Unit-VII (SEZ), 30, 90,500

Astra Zeneca, Indiana

Astra Zeneca, Indiana

Plot No. 15B, Phase 1

Janssen Ortho LLC,

Plot No. 15B, Phase 1

Unit - III Survey No.

Unit - III Survey No.

Unit - III Survey No.

Unit - III Survey No.

Unit III, Survey No.

Unit III, Survey No.

Unit III Survey No.

Unit - III Survey No. 6 blisters

10-day supply (5 two-

Efavirenz + Emtricitabine 600 mg + 200 Plot No. L-147, L147-1,

Efavirenz + Emtricitabine 600 mg + 200 Strides Arcolab Anekal Taluk,

Unit - III Survey No.

Unit - III Survey No.

[Emtricitabine + 200 mg /300 mg Macleods

Unit III Survey No.

Glaxo Operations UK,

Unit III 22-110, I.D.A.,

HDPE bottle 30, 60, 90

Unit III, Survey No.

D-7 MIDC Kurkumbh;

Lopinavir (LPV) + Abbott

Lopinavir (LPV) + Abbott

Lopinavir (LPV) + A-42, MIDC HDPE Bottle 120,

Unit III 22 - 110, HDPE

Cipla Ltd, Goa, India;

Plot No: S-155 to S-

Unit III Survey No.

Unit - III Survey No.

Unit III Survey No 313

S.C. Europharm, Bottle 100;

Unit III Survey No.

Disp. ERP Plot No A-33, A-2 HDPE

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