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  Biopharmaceuticals

  Branded Formulations

  - Oncology
  - Nephrology
  - Cardiology
  - Diabetology

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Oncology:

BIOMAb EGFR™

Composition:
Recombinant Humanized IgG1 Monoclonal Antibody

Mechanism of Action:
BIOMAb EGFR™ (Nimotuzumab) is a monoclonal antibody that specifically binds to the extracellular domain of the Epidermal Growth Factor Receptor (EGFR) and prevents signal transduction.

Indications:
Used in the treatment of advanced squamous cell carcinoma of the head and neck region with concurrent chemotherapy and / or radiotherapy. Also being globally studied in a range of solid tumor types, including colorectal cancer, lung cancer, glioma and pancreatic cancer.

NUFIL™ (Pre-filled Syringe)

Composition:
Recombinant Human-Granulocyte Colony Stimulating Factor (GCSF); filgrastim 300 µg

Mechanism of Action:
Filgrastim (produced in E. coli) is a nonglycosolated recombinant G-CSF used to stimulate the bone marrow to produce granulocytes and stem cells. G-CSF then stimulates the bone marrow to release them into the blood. It also stimulates the survival, proliferation, differentiation, and function of neutrophil precursors and mature neutrophils.

Indications:
Cancer patients receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; cancer patients receiving bone-marrow transplant (BMT); patients with severe chronic neutropenia; peripheral blood progenitor cell (PBPC) collection and therapy in cancer patients

NUFIL™ is incorporated with Ultrasafe Passive® Delivery System which enables protection from needle stick injuries and provides enhanced patient comfort.

Abraxane® for injectable suspension

Composition:
100 mg paclitaxel; 900 mg albumin; No Surfactants/Solvents

Mechanism of Action:
ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

nab™ Technology is the drug delivery platform for Abraxane. Nanoparticle albumin-bound (nab™) technology is a patented novel nanotechnology-based drug delivery platform developed by Abraxis Bioscience, USA

Nab technology exploits the natural properties of albumin to achieve safe, solvent-free, efficient and targeted drug delivery.

Indications:
ABRAXANE for Injectable Suspension is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
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Nephrology:

ERYPRO safe ( Prefilled Syringe)

Composition:
Recombinant Human Erythropoietin Alpha 2000IU/4000IU/10000IU

Mechanism of Action:
Erythropoietin stimulates red blood cell production in the bone marrow.

Indications:
- Used in the treatment of anemia associated with chronic kidney   disease, including end stage renal disease (ESRD), in patients   on dialysis or without dialysis.

- ERYPRO safe incorporates a unique technology which enables   safety from needle stick injuries and enhanced comfort to   patients.

TACROGRAF

Composition:
Tacrolimus 0.5mg/ 1mg/ 2mg/ 5mg capsules

Mechanism of Action:
Tacrolimus inhibits cellular mediated and antibody mediated immune response against a transplanted organ by preventing the activation of immune cells. This reduces the risk of rejection of transplanted organ and improves graft survival and function.

Indications:
Used as prophylaxis to prevent allograft rejection in organ transplantation.

RAPACAN

Composition:
Sirolimus 1mg film coated tablets

Mechanism of Action:
Inhibits the cellular and antibody mediated immune response against transplanted organ by preventing the proliferation of immune cells. Along with other immunosuppressants, it reduces the risk of rejection of transplanted organ.

Indications:
Used in prevention of rejection and rescue therapy in organ transplantation. Recommended in patients developing chronic allograft nephropathy with other immunosuppressants.

CYCLOPHIL ME

Composition:
Cyclosporine 25mg/ 50mg/100mg soft gel capsules
& Oral Solution with 100mg/ml in 50ml bottle

Mechanism of Action:
Inhibits the cellular and antibody mediated immune response against transplanted organ by preventing the activation of immune cells. Along with other immunosuppressants, it reduces the risk of rejection of transplanted organ and improves graft survival and function.

Indications:

Used as prophylaxis to prevent allograft rejection in organ transplantation.

RENODAPT

Composition:
Mycophenolate Mofetil 250mg capsules and 500mg tablets

Mechanism of Action:
It inhibits the cellular and antibody mediated immune response against transplanted organ by preventing the proliferation of immune cells. Along with other immunosuppressants, it reduces the risk of rejection of transplanted organ and improves graft survival and function.

Indications:
Used in prevention of rejection and rescue therapy in organ transplantation.

RENODAPT - S

Composition:
Mycophenolate Sodium 360 mg tablets

Mechanism of Action:
It inhibits the cellular and antibody mediated immune response against transplanted organ by preventing the proliferation of immune cells. Along with other immunosuppressants, it reduces the risk of rejection of transplanted organ and improves graft survival and function.

Indications:
Used in prevention of rejection and rescue therapy in organ transplantation. Recommended in patients who have gastrointestinal intolerability to Mycophenolate Mofetil.

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Cardiology:

STATIX

Composition:
Atorvastatin 10 & 20 mg tablets

Mechanism of Action:
Atorvastatin belongs to the category of Statins which inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Synthesis of mevalonic acid is impeded, which is a rate-limiting step in cholesterol biosynthesis. This results in a decrease in intracellular cholesterol leading to an increase in the number of synthesis of LDL receptors and increased clearance of LDL cholesterol in plasma. HMG-CoA reductase inhibitors may also lower plasma cholesterol levels by decreasing hepatic production of VLDL and LDL cholesterol.

Indications:
- Treatment of dyslipidemia (lipid disorders)

- Tablets taken orally to control cholesterol levels

STATIX-F

Composition:
Atorvastatin 10 mg + Fenofibrate (micronised) 200 mg tablets

Mechanism of Action:

Atorvastatin
Atorvastatin belongs to the category of Statins, which inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Synthesis of mevalonic acid is impeded, which is a rate-limiting step in cholesterol biosynthesis. This results in a decrease in intracellular cholesterol leading to an increase in the number of synthesis of LDL receptors and increased clearance of LDL cholesterol in plasma. HMG-CoA reductase inhibitors may also lower plasma cholesterol levels by decreasing hepatic production of VLDL and LDL cholesterol.

Fenofibrate
Fenofibrate activates peroxisome proliferator-activated receptors (PPAR-a), which induce an increase in LP lipase activity, a reduction in Apo C-III, an increase in Apo A-I, as well as a reduction in cholesterol ester transfer protein activity. These result in triglyceride level reduction, redistribution of LDL particle size from small dense to large buoyant and an HDL cholesterol increase.

Indications:
- Treatment of dyslipidemia (lipid disorders)

- Controls high LDL and triglyceride levels

- More suited for patients with Diabetes

STATIX-EZ

Composition:

Atorvastatin 10 mg + Ezetimibe 10 mg tablets

Mechanism of Action:


Atorvastatin
Atorvastatin belongs to the category of Statins, which inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Synthesis of mevalonic acid is impeded, which is a rate-limiting step in cholesterol biosynthesis. This results in a decrease in intracellular cholesterol leading to an increase in the number of synthesis of LDL receptors and increased clearance of LDL cholesterol in plasma. HMG-CoA reductase inhibitors may also lower plasma cholesterol levels by decreasing hepatic production of VLDL and LDL cholesterol.

Ezetimibe

Ezetimibe is a selective cholesterol absorption inhibitor, which potently and selectively prevents absorption of cholesterol from dietary and biliary sources by preventing transport of cholesterol through the intestinal wall. This reduces the overall delivery of cholesterol to the liver, thereby promoting the synthesis of LDL receptors and a subsequent reduction in serum LDL-C. Ezetimibe does not affect the absorption of fat-soluble vitamins.

Indications:

- Treatment of dyslipidemia (lipid disorders)

- Controls very high LDL levels

CLASPRIN

Composition:
Aspirin 75mg + Clopidogrel 75mg tablets

Mechanism of Action:

Aspirin

Aspirin inhibits the formation of thromboxane A2 in the platelets. This inhibits platelet aggregation and coagulation. This action lasts until enzyme cyclo-oxygenase is regenerated in the platelets.

Clopidogrel
Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of glycoprotein GP IIb/IIIa complex, thereby inhibiting platelet aggregation.

Indications:

- Prevention of ischemic events, myocardial infarction (heart   attacks, stroke and cardiovascular death in patients with acute   coronary syndrome)

- Prevents formation of blood clots in an intact artery

TELMISAT

Composition:

Telmisartan 20, 40 & 80mg tablets

Mechanism of Action:
Telmisartan is angiotensin II receptor antagonist which is very potent in inhibiting angiotensin II - AT1 receptor subtype with high selectivity.

Angiotensin II is the principal pressor agent that causes vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.

At doses of 20, 40, and 80 mg, the antihypertensive effect of once daily administration of telmisartan is maintained for the full 24-hour dose interval.

Indications:

Treatment of mild to moderate hypertension. Used individually or in combination with any other antihypertensive agents.

TELMISAT H

Composition:
Telmisartan 40 mg + Hydrochlorothiazide12.5 mg

Mechanism of Action:

Telmisartan
Telmisartan is angiotensin II receptor antagonist which is very potent in inhibiting angiotensin II - AT1 receptor subtype with high selectivity. Its action is independent of the pathways for angiotensin II synthesis. Telmisartan does not bind to or block other hormone receptors or ion channels which have a role in cardiovascular regulation.

Hydrochlorothiazide
Hydrochlorothiazide is a thiazide type diuretic. Thiazides affect renal tubular mechanism of electrolyte reabsorption and increase excretion of sodium and chloride in approximately equivalent amounts. Natriuresis causes a secondary loss of potassium.

Indications:
Treatment of moderate to severe hypertension when blood pressure is not adequately controlled with telmisartan alone

TELMISAT R 2.5 & 5

Composition:
TELMISAT R 2.5
Telmisartan 40 mg + Ramipril 2.5 mg

TELMISAT R 5
Telmisartan 40 mg + Ramipril 5 mg

Mechanism of Action:

Telmisartan
Telmisartan is angiotensin II receptor antagonist which is very potent in inhibiting angiotensin II - AT1 receptor subtype with high selectivity. Its action is independent of the pathways for angiotensin II synthesis.

Ramipril
Competitively inhibits angiotensin converting enzyme (ACE), resulting in prevention of angiotensin I conversion to angiotensin II, a potent vasoconstrictor.

Indications:
- Treatment of diabetic and non- diabetic nephropathy

- Treatment of Congestive Heart Failure

- Treatment of high-risk patients with hypertension

ZARGO

Composition:

Losartan 25 & 50 mg tablets

Mechanism of Action:

Losartan is an oral medication that belongs to a class of drugs called angiotensin receptor blockers (ARBs). Angiotensin, formed in the blood by the action of angiotensin converting enzyme (ACE), a powerful chemical that attaches to angiotensin II receptors found in many tissues but primarily on smooth muscle cells of blood vessels.

Angiotensin's attachment to the receptors causes the blood vessels to narrow (vasoconstriction) which leads to an increase in blood pressure (hypertension). Losartan (more specifically, the chemical formed when the liver converts the inactive losartan into an active chemical) blocks the angiotensin receptor. By blocking the action of angiotensin II, losartan dilates blood vessels and thereby reduces blood pressure.

Indications:

- Treatment of mild to moderate hypertension

- Indicated in decreasing the risk of stroke in patients with high   blood pressure and a condition called left ventricular   hypertrophy (LVH)

- Also indicated to treat diabetic nephropathy


ZARGO H


Composition:

Losartan 50 mg + Hydrochlorothiazide 12.5 mg tablets

Mechanism of Action:


Losartan
Losartan the first of a new class of anti-hypertensives. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland)

Hydrochlorothiazide
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect renal tubular mechanism of electrolyte reabsorption and increase excretion of sodium and chloride in approximately equivalent amounts. Natriuresis causes a secondary loss of potassium.

Indications:
- Used as an anti-hypertensive agent for the management of   hypertension that is not controlled by treatment with single   anti-hypertensive agent.

ZIGPRIL

Composition:

Ramipril 2.5 & 5 mg tablets

Mechanism of Action:
Competitively inhibits angiotensin converting enzyme, resulting in prevention of angiotensin I conversion to angiotensin II, a potent vasoconstrictor.

Clinical consequences include decrease in BP and indirect (by inhibiting aldosterone) decrease in sodium and fluid retention and increase in diuresis.

Indications:
- For the treatment of mild to moderate hypertension

- Used for the treatment of hypertension with heart failure, post   myocardial infarction, with renal impairment

- Also useful in reduction of myocardial infarction, stroke and   death from cardiovascular causes
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Diabetology:

INSUGEN R

Composition:
Soluble/ Regular Insulin - 10ml vials of 40iu/ml strength

Mechanism of Action:
Insulin opens the cell receptors for glucose molecules to enter which in turn is utilized in the form of energy (ATP) to carry out the various activities by the body. It starts its action after 30 mins of injection and attains peak after 2 hrs, remaining in the body for upto 6-8 hrs.

Indications:
- All types of diabetes mellitus.

- For quick action and faster peak of insulin.

- Taken as subcutaneous injection to control post-meal surge in   blood glucose.

- Also used in the ICUs and wards as IV (intravenous). Only   insulin which can be given through IV.

INSUGEN N

Composition:
Isophane (NPH) insulin - 10ml Vials of 40iu/ml strength

Mechanism of Action:

Insulin opens the cell receptors for glucose molecules to enter which in turn is utilized in the form of energy (ATP) to carry out the various activities by the body. Used to maintain the basal level of insulin in the body. Starts working after approx 1-2 hrs of injection, gets the slight peak after 6-8 hrs and remains in the body for about 10-12 hrs.

Indications:
-
All types of diabetes mellitus.

- Used to maintain fasting blood glucose level.

- Also known as bed time insulin.

- Taken as subcutaneous injection only.

INSUGEN 30/70

Composition:
Insulin biphasic, 30% Soluble and 70% NPH - 10ml vials of 40iu/ml strength.

Mechanism of Action:
Insulin opens the cell receptors for glucose molecules to enter which in turn is utilized in the form of energy (ATP) to carry out the various activities by the body. It starts its action after 30min-1 hr of injection. 30% soluble insulin achieves peak level after 2 hrs of injection and 70% of NPH achieves peak level after approx 6-8 hrs of injection, remaining in the body for about 10-12 hrs. Excretion is basically through the kidneys.

Indications:
- All types of diabetes mellitus.

- Taken as subcutaneous injection, can be given as once or    twice daily.

- To keep blood glucose levels under control.

INSUGEN 50/50

Composition:

50% soluble and 50% NPH - 10ml vials of 40iu/ml strength

Mechanism of Action:
Insulin opens the cell receptors for glucose molecules to enter which in turn is utilized in the form of energy (ATP) to carry out the various activities by the body. It starts its action after 30min-1 hr of injection. 30% soluble insulin gets its peak after 2 hrs of injection and 70% of NPH gets its peak after approx 6-8 hrs of injection, remaining in the body for about 10-12 hrs. Excretion is basically through the kidneys.

Indications:
- All types of diabetes mellitus.

- Taken as subcutaneous injection, can be given as once or   twice daily.

- To keep blood glucose levels under control.

BLISTO 1 & 2


Composition:
Glimepiride 1 mg & 2 mg tablets

Mechanism of Action:

A sulphonylurea, it reduces blood glucose by induing islet cells of the pancreas to secrete insulin. Glimepiride also has other beneficial effects on the metabolism.

Indications:
- In the treatment of type II Diabetes mellitus

- Used as a single drug or in combination with other drugs
  e.g. Metformin, Pioglitazone, etc. to control blood glucose   levels

BLISTO MF 1 & 2

Composition :

- Blisto 1MF-Glimepiride 1 mg + Metformin 500 mg tablets

- Blisto 2MF- Glimepiride 2 mg + Metformin 1000 mg tablets

Mechanism of Action:
Glimepiride acts by stimulating the release of insulin from functioning pancreatic beta cells. In addition, extra-pancreatic effects may also play a role in the activity of Glimepiride. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity.

Indications:
- In the treatment of type II diabetes mellitus

- Used when one anti-diabetes drug fails to control blood
   glucose level

Metadoze IPR

Composition:
Metformin 850 mg tablets with IPR (Immediate and Patterned Release technology)

Mechanism of Action:

Metformin, belonging to the class of anti-diabetes drugs, Biguanide, improves insulin sensitivity. Its extra pancreatic actions include reduction of hepatic glucose production, potentiation of insulin actions, increased peripheral utilisation of glucose and delayed intestinal absorption of sugars and starches.

Indications:
- In the treatment of type II diabetes mellitus

- Used as a single drug or in combination with other drugs       e.g. glimepiride, pioglitazone, etc. to control blood glucose   levels

Metadoze IPR incorporates a unique technology which enables immediate and sustained release of Metformin. This not only makes Metformin longer acting, but also improves absorption and reduces side effects.

PIODART


Composition:

Pioglitazone 15 mg & 30 mg tablets

Mechanism of Action:

Pioglitazone exerts its pharmacological effects by acting as a potent and highly selective agonist for the peroxisome proliferators activated receptor-gamma. Activation of these receptors promotes the transcription of several insulin responsive genes that help control lipid metabolism and glucose levels. It also reduces insulin resistance in the periphery and in the liver of patients.

Indications:
- In the treatment of type II diabetes mellitus

- Improved Insulin action as well has favorable effects on lipid   levels

PIODART MF


Composition:
Pioglitazone 15 mg + metformin 500 mg tablets

Mechanism of Action:


Pioglitazone
Pioglitazone exerts its pharmacological effects by acting as a potent and highly selective agonist for the peroxisome proliferators activated receptor-gamma. Activation of these receptors promotes the transcription of several insulin responsive genes that help control lipid metabolism and glucose levels. It also reduces the insulin resistance in the periphery and in the liver of patients.

Metformin
Metformin decreases hepatic glucose production and intestinal absorption of glucose while improving insulin sensitivity.

Indications:

- In the treatment of type II diabetes mellitus

- Used when one anti-diabetes drug fails to control blood   glucose level. This combination effectively reduces insulin   resistance both at liver and peripheral tissues.

TriGPM

Composition:
- TriGPM 1 (Glimepiride 1mg + Pioglitazone 15mg + Metformin
500 mg tablets)

- TriGPM 2 (Glimepiride 2mg + Pioglitazone 15mg + Metformin
500 mg tablets

Mechanism of Action:

Glimepiride

The primary mechanism of action of glimepiride in lowering blood glucose appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. In addition, extrapancreatic effects may also play a role in the activity of sulphonylureas such as glimepiride.

Pioglitazone

Pioglitazone is a thiazolidinedione anti-diabetic agent that depends on the presence of insulin for its mechanism of action. Pioglitazone decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Unlike sulphonylureas, pioglitazone is not an insulin secretagogue. Pioglitazone is a potent and highly selective agonist for peroxisome proliferator-activated receptor- γ (PPAR- γ ). PPAR receptors are found in tissues important for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPAR- γ nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism.

Metformin
Metformin is an oral anti-hyperglyacemic drug used to improve glucose tolerance in patients with type II diabetes (NIDDM), lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Indications:
- In the treatment of type II diabetes mellitus.

- Used as second/ third-line therapy when diet, exercise and   single agents/dual therapy do not result in adequate glycaemic   control in patients with type II diabetes.


ZUKER – MF

Composition:
Gliclazide 80 mg + Metformin 500 mg tablets.

Mechanism of Action:
Belongs to the class of antidabetic- sulphonyurea. Stimulates insulin secretion through pancreatic beta cells. In the long term, reduces hepatic gluconeogenesis and increases insulin effects by acting as receptor or post receptor sites.

Indications:
- In the treatment of type II diabetes mellitus

- Used when a single anti-diabetes drug fails to control blood   glucose level

GABIL

Composition:

Gabapentin 300 mg + Methylcobalamin 500 mcg tablets

Mechanism of Action:

Gabapentin
Action is potentially via binding to the alpha 2 delta subunits of voltage gated calcium channels and inhibition of glutamide release presynaptically and postsynaptically in the CNS. It also stabilizes the nerve membrane by inhibiting calcium ion channel, therefore minimizing abnormal synthesis / firing of impulses.

Methylcobalamin

Methylcobalamin, through its myelin sheath and nerve regeneration action, prevents progressive nerve damage.

Indications:
- Controlling pain of neuropathy of all types, especially diabetes.

- Useful as symptomatic therapy.


GMAB Plus


Composition:
GLA 100mg + Methylcobalamin 1500 mcg + ALA 100 mg + Benfothiamine 100 mg + Ele. Zinc 15mg - Hard gelatin capsules

Mechanism of Action:
It is a multivitamin with mineral which acts as a secondary preventive agent.

Indications:
As a dietary/nutritional supplement in patients suffering from diabetes and cardiovascular diseases.

OLISAT

Composition:
Orlisat 60 mg & 120 mg capsules.

Mechanism of Action:

Orlistat works by blocking the action of enzymes which break down fat. Fats in our diet cannot be absorbed unless broken down in to smaller components known as fatty acids. Orlistat prevents this breakdown of fat and the undigested fat is passed in the stool. This drug does not suppress appetite. It works within the gut and is not absorbed into the bloodstream.

Indications:
- Obesity management, including weight loss and weight   maintenance when used in conjunction with a reduced-calorie   diet

- To reduce the risk for weight regain after prior weight loss

- For obese patients with an initial body mass index (BMI) = 30   kg/m2 or = 27 kg/m2 in the presence of other risk factors   (e.g., hypertension, diabetes, dyslipidemia)

- Olisat 120 for obese patients and Olisat 60 for overweight patients


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