Medical Products : Plasma Proteins

AlbuRel (Albumin) ImmunoRel (Immunoglobulin) ReliSeal (Fibrin Sealants) HemoRel A (Anti - Hemophilic Factor)

Recombinant Proteins

ReliFeron (Recombinant Interferon ) ReliPoietin (Erythropoietin) ReliGrast (GCSF) MIRel (Recom Reteplase- tissue plasminogen activator) FostiRel (Follicle stimulating hormone) ReliBeta (Recombinant Interferon beta-1a)

Pharmaceutical Formulations

TemoRel (Temozolomide) ReliCitabine (Capecitabine) ReliTrexed (Permetrxed) ImatiRel (Imatinib mesytate)

Stem Cell Therapies

ReliNethra (Autologous limbal stem cells graft) ReliNethra C CardioRel (Autologous cardiomyocytes) ReliCord (KIT - embryonic stem cells)

Tissue Engineering Products

ReliHeal - G (Biopolymer wound management product)

Molecular Medicine Services

Relix (Service- diagnosing diseases and genetic disorders)

Temozolomide is a prodrug, orally administered alkylating agent of the imidazotetrazine class, rapidly and completely absorbed and, at physiological pH, spontaneously hydrolyzed into the active metabolite. Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e. patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. TemoRel is available as capsules of 20, 100 and 250 mg. Product literature -------------------------ImmunoRel is a solvent detergent treated, chromatographically purified immunoglobulin G(IgG) derived from pooled human plasma. The approved indications include Primary Immunodeficiency (PID), Kawasaki disease, Idiopathic Thrombocytopenic Purpura, B-cell Chronic lymphocytic leukaemia, Paediatric HIV 1 infection and Hemopoietic stem cell transplantation in elderly. The clinical experience has also shown efficacy in GB syndrome, Multifocal Motor Neuropathy, CIDP, Lambert Eaton Myasthenic syndrome, Myasthenia Gravis, Neonatal Sepsis, Polymyositis, Dermatomyositis and few others. The normal immunoglobulin is meant for intravenous use. ImmunoRel is available in 5% concentrations in 10 ml, 20 ml, 50 ml and 100 ml pack sizes.

ReliSeal is biological glue and haemostatic agent, which can be used in a variety of surgical procedures to arrest bleeding, seal tissues and as an adjunct to wound healing. A quick acting surgical fibrin sealant derived from human blood plasma, with haemostatic sealing and adhesive properties, ReliSeal mimics the final stage of the natural clotting mechanism. The kit is available in 0.5 ml and 1 ml pack size.

HemoRel A is a 250 IU and 500 IU preparation of clotting factor VIII. HemoRel A is indicated for replacement of factor VIII in patients, who have factor VIII deficiency i.e. patients diagnosed with haemophilia A. Factor VIII replacement is the therapy of choice for clotting disorder in haemophilia A. HemoRel A is purified Factor VIII manufactured by ion exchange chromatography. It contains intact Factor VIII complex i.e. F VIII:C and von Willebrand Factor (vWF) and fibrinogen is below detection levels. HemoRel A is made virus safe by Double Viral Inactivation: by Solvent-Detergent method and Heat treatment. The product pack is user-friendly and kit includes one 20 ml syringe, two needles, water for injection, syringe filter and spirit swab.

ReliFeron belongs to the class of interferons (IFNs) which are natural proteins produced by the cells of the immune system in response to foreign agents such as viruses, bacteria, parasites and tumor cells. Interferons are produced in body primarily from leukocyte, fibroblast and immune cell and the important ones are Interferons assist the immune response by activating natural killer cells and macrophages, promoting antigen presentation to lymphocytes and thus inducing the resistance of host cells against foreign agents. Interferons also have direct antiviral effects. Recombinant IFN-a is now approved worldwide in over 40 countries for the treatment of more than 14 malignancies and viral diseases, including adjuvant therapy in metastatic melanoma, condyloma acuminata, Kaposi's sarcoma and most importantly hepatitis B and C. Interferon-a has been shown to be effective in suppressing viral replication and in inducing remission of liver disease caused by chronic hepatitis B and hepatitis C virus infection.

ReliFeronis a purified sterile human recombinant interferon product classified as an alpha interferon. It has 165 amino acids, with a molecular weight of 19 kDa. ReliFeron is obtained by recombinant technology using Escherichia coli with an interferon alpha 2b gene from human leukocytes. It is used in the form of parenteral injection. Each vial of ReliFeroncontains 3 or 5 million IU recombinant human interferon alpha 2b in 0.5 mL of aqueous buffer. Product literature

Erythropoietin (EPO) belongs to the class of Erythropoiesis Stimulating Agents, i.e it work as a growth hormone and stimulates production of red blood cells from the hematopoietic stem cells in the bone marrow. It is solely produced by the kidney cells, and thus, any functional damage to the kidneys can result in EPO deficiency and reduction in production of RBC pool that eventually leads to anemia. ReliPoietin is erythropoietin alpha, conventionally used to reverse anemic condition that is arising because of body's inability to produce required amount of erythropoietin, and thus, reduced pool of red blood cells. It is used as a support therapy in the treatment of Acute, chronic and end-stage renal failure; in cancerinduced and chemotherapy-related anemia; in patients undergoing major surgeries; and in AIDS patients on zidovudine treatment. The aim of therapy is to reduce the number of dialysis required by the renal failure patients, better tolerance of chemotherapy and reduced number of blood transfusions in case of cancer patients; and overall improved quality of life in these patients. ReliPoietin, is a glycoprotein containing 165 amino acids. The molecular weight is 30 kD, with 40% glycosylation. The upstream processing including the cell lines (Chinese Hamster Ovary) used and the downstream processing yields erythropoietin that is exactly similar to the innovator's product. Even the isoform distribution, which is one of the determinants of efficacy, is same as that of the innovator's product and the biological reference protein. ReliPoietin is available as pre-filled syringes in the strengths of 2000, 3000, 4000, 6000, 10,000 and 40,000 IU Product literature
Medical Products

ReliGrast is human recombinant Granulocyte Colony Stimulating Factor (G-CSF), which is a specific growth factor known to stimulate production of neutrophils, a type of white blood cells in the body that are essential for fighting infections. It is active during the normal course of hematopoiesis and the hematopoietic stem cells get differentiated into white blood cells in the presence of G-CSF. G-CSF is a protein having 175 amino acids, and has no glycosylation. E.coli is used for commercial manufacturing of recombinant G-CSF as a biosimilar. ReliGrast can be therapeutically used for reversing neutropenic conditions due to various reasons. It can be used in chemotherapy induced neutropenia, AIDS-associated neutropenia, congenital, cyclic idiopathic neutropenia. In the clinical trials conducted, ReliGrast has demonstrated efficacy in reducing the duration of Neutropenia (compared to 9 days) and recovery after ANC Nadir. The reduction in the incidence of Febrile Neutropenia, Grade 4 Neutropenia and Infection is also significant. ReliGrastis available in the strength of 300 mcg/0.5 ml, as a pre-filled syringe. Product literature MIRel (Reteplase) is a single chain deletion mutant of alteplase that is expressed in Escherichia coli and, therefore, is expressed as an unglycosylated protein (355 amino acids) with a total molecular weight of 39 kDa. The molecule consists of cringle 2 and the protease domain of the alteplase molecule. Because of the deletion of the fibronectin finger region, the binding of reteplase to fibrin is significantly reduced in comparison with that of alteplase. Although kringle 2 (known to stimulate protease in the presence of fibrin) is part of the reteplase molecule, reteplase is stimulated in the presence of fibrin to a lower extent than alteplase, suggesting that the fibronectin finger is involved in the stimulation of the protease as well. Reteplase, in comparison with alteplase, is characterised by reduced fibrin selectivity. In the abscence of fibrin, reteplase and alteplase do not differ with respect to their activity as plasminogen activators, nor do they differ with respect to their inhibition by the plasminogen activator inhibitor type 1 (PAI-1). The elimination of reteplase from the circulating plasma predominantly occurs in the liver. Because of the deletion of the fibronectin finger region, the epidermal growth factor domain and kringle 1, as well as the carbohydrate side chains, the hepatic elimination of the molecule is reduced. Consequently, plasma half life is increased to 1418 minutes (versus 3-4 minutes with alteplase). This allows reteplase to be administered as boli (versus as an initial bolus followed by an infusion, as with alteplase). The best results have been obtained with a double bolus of 10 U each 30 minutes apart in the case of an acute myocardial infarction. Reteplase was superior to alteplase (administered over three hours) with respect to patency of the infarct related coronary artery. With reteplase patency was reached earlier

and more frequently than with alteplase. Each kit of MIRel contains two vials of 10 units of Reteplase each, sterile water for injection, two syringes and four needles Product literature Clinical trial synopsis

MIRel (Reteplase) is a single chain deletion mutant of alteplase that is expressed in Escherichia coli and, therefore, is expressed as an unglycosylated protein (355 amino acids) with a total molecular weight of 39 kDa. The molecule consists of cringle 2 and the protease domain of the alteplase molecule. Because of the deletion of the fibronectin finger region, the binding of reteplase to fibrin is significantly reduced in comparison with that of alteplase. Although kringle 2 (known to stimulate protease in the presence of fibrin) is part of the reteplase molecule, reteplase is stimulated in the presence of fibrin to a lower extent than alteplase, suggesting that the fibronectin finger is involved in the stimulation of the protease as well. Reteplase, in comparison with alteplase, is characterised by reduced fibrin selectivity. In the abscence of fibrin, reteplase and alteplase do not differ with respect to their activity as plasminogen activators, nor do they differ with respect to their inhibition by the plasminogen activator inhibitor type 1 (PAI-1). The elimination of reteplase from the circulating plasma predominantly occurs in the liver. Because of the deletion of the fibronectin finger region, the epidermal growth factor domain and kringle 1, as well as the carbohydrate side chains, the hepatic elimination of the molecule is reduced. Consequently, plasma half life is increased to 14-18 minutes (versus 3-4 minutes with alteplase). This allows reteplase to be administered as boli (versus as an initial bolus followed by an infusion, as with alteplase). The best results have been obtained with a double bolus of 10 U each 30 minutes apart in the case of an acute myocardial infarction.

Reteplase was superior to alteplase (administered over three hours) with respect to patency of the infarct related coronary artery. With reteplase patency was reached earlier and more frequently than with alteplase. Each kit of MIRel contains two vials of 10 units of Reteplase each, sterile water for injection, two syringes and four needles Product literature Clinical trial synopsis

MIRel (Reteplase) is a single chain deletion mutant of alteplase that is expressed in Escherichia coli and, therefore, is expressed as an unglycosylated protein (355 amino acids) with a total molecular weight of 39 kDa. The molecule consists of cringle 2 and the protease domain of the alteplase molecule. Because of the deletion of the fibronectin finger region, the binding of reteplase to fibrin is significantly reduced in comparison with that of alteplase. Although kringle 2 (known to stimulate protease in the presence of fibrin) is part of the reteplase molecule, reteplase is stimulated in the presence of fibrin to a lower extent than alteplase, suggesting that the fibronectin finger is involved in the stimulation of the protease as well. Reteplase, in comparison with alteplase, is characterised by reduced fibrin selectivity. In the abscence of fibrin, reteplase and alteplase do not differ with respect to their activity as plasminogen activators, nor do they differ with respect to their inhibition by the plasminogen activator inhibitor type 1 (PAI-1). The elimination of reteplase from the circulating plasma predominantly occurs in the liver. Because of the deletion of the fibronectin finger region, the epidermal growth factor domain and kringle 1, as well as the carbohydrate side chains, the hepatic elimination of the molecule is reduced. Consequently, plasma half life is increased to 14-18 minutes (versus 3-4 minutes with alteplase). This allows reteplase to be administered as boli (versus as an initial bolus followed by an infusion, as with alteplase). The best results have been obtained with a double bolus of 10 U each 30 minutes apart in the case of an acute myocardial infarction. Reteplase was superior to alteplase (administered over three hours) with respect to patency of the infarct related coronary artery. With reteplase patency was reached earlier and more frequently than with alteplase. Each kit of MIRel contains two vials of 10 units of Reteplase each, sterile water for injection, two syringes and four needles

Product literature Clinical trial synopsis

FostiRel is recombinant follitropin beta stimulating hormone (r-FSH). FSH is a fertility hormone that is responsible for folliculogenesis and ovulation in females . It also indicated for spermatogenesis in males Amongst females with infertility, ovulatory problems like anovulation are responsible for around 25% of cases, while in case of males, azoospermia or oligzoospermia are most prominent contributing reasons. Recombinant FSH, since it is a pure protein product, containing only FSH and no contaminants, subcutaneous administration is advocated. In this case, the pharmacokinetics does not seem to be affected. Subcutaneous administration, in fact, improves the patient compliance. FostiRel is available as multi dose vials in strengths of 300 IU, 900 IU and 1200 IU. Multiple tests prove the product to be exactly similar to the innovator, in terms of product identity and purity. Product literature

Interferons are a family of naturally occurring proteins and glycoproteins that are produced by eukaryotic cells in response to viral infection and other biological inducers. Interferon beta, a member of interferon family, is produced by various cell types including fibroblasts and macrophages. Recombinant interferon beta-1a is a glycosylated protein with a single N-linked glycosylation site, similar to the natural interferon beta-1a. Interferon beta exerts its biological effects by binding to specific receptors on the surface of human cells. This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers. The actions of interferon beta have the net effect of reducing the immune response that is directed against central nervous system myelin in people with MS. ReliBeta (recombinant Interferon beta-1a) is a 166 amino acid glycoprotein with a molecular weight of approximately 22 kD. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of ReliBeta is identical to that of natural human interferon beta.

ReliBeta is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. ReliBeta is a sterile, preservative-free, clear colourless liquid for intramuscular injection. ReliBeta is available as a ready for use pre-filled glass syringe with 0.5 ml fill volume. Each 0.5 ml in a pre-filled glass syringe contains 30 g of interferon-beta-1a in sodium acetate aqueous buffer containing L-arginine hydrochloride and polysorbate 20.

Temozolomide is a prodrug, orally administered alkylating agent of the imidazotetrazine class, rapidly and completely absorbed and, at physiological pH, spontaneously hydrolyzed into the active metabolite. Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e. patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. TemoRel is available as capsules of 20, 100 and 250 mg. Product literature

Capecitabine is a fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug which is converted to 5-fluorouracil. Capecitabine is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. It is also indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred and in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. ReliCitabine is available as 500 mg tablets. Product literature

Medical Products

Pemetrexed disodium heptahydrate is chemotherapeutic agent and it falls in the class of anti-metabolites. It is supplied as a sterile lyophilized powder for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of ReliTrexed contains pemetrexed disodium equivalent to 100 mg pemetrexed or 500 mg. Pemetrexed is indicated in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer. It is indicated as a single-agent for the treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy and in combination with cisplatin is indicated for the treatment of patients with malignant mesothelioma whose disease is unresectable or who are otherwise are not candidates for curative surgery. ReliTrexed is available in 100 and 500 mg vials. Product literature

Imatinib mesylate is an orally administered, synthetic tyrosine kinase inhibitor (three known targets are ABL, c-kit, PDGF receptor). It is rapidly absorbed , and is highly bioavailable. Most of imatinib is eliminated as metabolites, only 25% of it is eliminated unchanged. The half-lives of imatinib and its main metabolite are 18 and 40 hours respectively. It is used in the treatment of chronic myeloid leukaemia (CML) and GIST. It is also approved as a single agent for the treatment of dermatofibrosarcoma protuberans (DFSP), myelodysplastic / myeloproliferative diseases (MDS/MPD), aggressive systemic mastocytosis (ASM), hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL), and relapsed/refractory Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL). ImatiRel is available as 100 and 400 mg tablets. Product literature