PHARMIKA INDIA PVT LTD.
Lifesaving Drugs/Critical Care

Lifesaving Drugs/Critical Care

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Lifesaving Drugs

Critical care, a forefront arm of Pharmika plays an eminent role in the manufacturing of recently approved finished formulations of critical care products. The need for more advanced critical care has inspired pharmika to foster the technology and put the expertise of its researchers at work in the development of critical care products. We aim at including all the aspects of the disease and the medicines in development of critical care products that works on varied ailments – antibiotics, antifungals, antivirals, anti-infectives etc.

The production facility at Pharmika is developed taking into account various safety and quality standards. We adhere to various safety measures in order to safeguard the working environment and interests of our personnel. The ultra-modern production units at Pharmika include dedicated areas for research, production and packaging. These units are designed to match international standards.

The varied range of critical care products manufactured by Pharmika helps recover patients and to prevent and reduce the risks induced by high resistant infections for patients in critical care units, pre & post surgical complications & infectious diseases. The critical care production unit is into manufacturing of various injectable, dry powder inhaler, Lyophilized injections, tablets and prefilled syringes. Our team has been successful in developing next generation Carbapenems like Ertapenem, Doripenem. Our manufacturing includes some of the commonly used ICU products like Amoxcillin/Clavulanic acid, Azithromycin, Heparin, Paracetamol injections, Vancomycin etc.

S. NoProduct NameDosage FormStrength
1Azithromycin for injectionLyophilizate0.5 g
2Clarithromycin for injectionLyophilizate0.5 g
3Tigecycline for injectionLyophilizate50 mg
4Teicoplanin for injectionLyophilizate0.2 g & 0.4 g
5Polymyxin B for injectionLyophilizate25 mg & 50 mg
6Vancomycin + WFIDry powder injection0.5 g & 1 g
7Meropenem for injectionDry powder injection0.5 g & 1 g
8Imipenem & Cilastatin for injectionDry Powder injection0.5 g
9Doripenem for injectionDry Powder injection0.5 g
10Ertapenem for injectionLyophilizate1 g
11Enoxaparin PFSPFS20,40,60,80 & 100 mg
12Heparin PFSLiquid injection5000 IU
13Omeprazole for injectionLyophilizate20 mg
14LevosimendanIV infusion12.5 mg & 25 mg
15EptifibatideLiquid injection20 mg & 75 mg
16BivalirudinLyo injection250 mg
17Colistemethate Sodim for injectionLyophilizate1 M & 2 M IU
18Caspofungin for injectionLyophilizate50 mg & 70 mg
19Voriconazole for injectionLyophilizate0.2 g
20Daptomycin for injectionLyophilizate0.35 g & 0.5 g

Critical Care Product Information

S. NoProduct NameProduct information
1Clarithromycin
2Meropenem
3Piperacillin + Tazobactam
4Enoxaparin

Cephalosporins, a new class of antibiotics are an incredible part of the medicine world. Cephalosporins are developed to fight against bacteria and used as first line antibiotics to inhibit bacterial growth in human body. It is often used as an alternative for penicillin in fighting infections.

The line of production set for cephalosporin needs high level of precision and control. Pharmika holds a capacity to produce both oral and injectable cephalosporins. Our production capacity is designed, taking into account the globally accepted medical norms and regulations. We at Pharmika put in expert intelligence and modern technology in controlling the manufacturing of cephalosporins. We deliver consistent high quality and reliable products.

Cephalosporins unit have capacity to manufacture 25 million vials of sterile dry powder for injection per annum, 230 mln oral dosage of tablets and 160 mln oral dosage of capsules per annum.

Cephalosporin’s Product Information

S. NoProduct NameDosage FormStrength
1Ceftriaxone for injection USP + WFIDry Powder injection0.5 g & 1 g
2Cefepime for injection USP + WFIDry Powder injection0.5 g & 1 g
3Cefuroxime for injection USP + WFIDry Powder injection0.75 g & 1.5 g
4Cephalothin for injection USPDry Powder injection1 g
5Cefotaxime for injectionDry Powder injection0.5 g & 1 g
6Cefoperazone + Sulbactam for injectionDry Powder injection1g + 1g
7Ceftazidime for injection USPDry Powder injection0.5 g & 1 g
8Cefoxitin for injectionDry Powder injection2 g
9Cefazolin for InjectionDry Powder injection0.5 g & 1 g
10Cefpirome for InjectionDry Powder injection1 g
11Ceftriaxone + Tazobactum injectionDry Powder injection1 g + 0.125 g
12Cefepime + Sulbactum InjectionDry Powder injection0.5 g + 0.125 g
13Ceftazidime + Avibactam injectionDry Powder injection2 g + 0.5 g
14Cefamandole nafateDry Powder injection1gm

Product Description

PlasmaHep is a sterile, clear to opalescent, colourless to pale yellow solution. It contains not more than 180g/L human plasma proteins of which at least 90% is human immunoglobulins (mainly gamma globulins IgG), with Hepatitis B antibody titer of not less than 200IU/mL. PlasmaHep contains more than 90% of monomeric and dimeric IgG.

To increase margin of safety, effective steps in extensive testing protocols have been integrated into manufacturing and formulation process to ensure contamination free product from HBsAg, anti- HIV I & II, anti-HCV, HBV-DNA, HCV-RNA, HIV-RNA by PCR.

Indications

  • Acute Exposure to Blood Containing HBsAg
  • Perinatal Exposure of Infants Born to HBsAg-Positive Mothers
  • Sexual Exposure to an HBsAg-Positive Person
  • Household Exposure to Persons with Acute HBV Infection

Storage

  • Store below 10°C without freezing

Shelf-life

30 months from the date of manufacture

Product Name

PlasmaHep


Generic Name

Human Hepatitis-B Immune Globulin


Strengths Avaliable

100 I.U. in 0.5 mL

Product Description

PlasmaGlob is Normal Human Immunoglobulin for Intravenous use prepared from Indian Human Plasma from healthy voluntary donors, by Cohn Fractionation/ Chromatography process. Each unit of plasma is tested for all mandatory serological markers prescribed by National Regulatory Authority (NRA).

To increase safety profile of PlasmaGlob , the plasma used in its manufacturing and final product undergoes extensive testing from various protocols HBsAg, Ab-Ag HIV, anti-HCV by ELISA and for HBV-DNA, HCV-DNA, HAV-RNA, HIV-RNA, Parvovirus B19-DNA by NAT/PCR.

Only the non-reactive plasma units were used for manufacturing of PlasmaGlob. To further improve the margin of safety effective viral inactivation steps like solvent detergent treatment have been integrated into the manufacturing and formulation process. PlasmaGlob has undergone two steps of viral inactivation. As per the regulatory norms and Hemovigilance program, the record of plasma used in manufacturing of PlasmaGlob has been maintained for 10 years.

Indications

  • Primary Immune Deficiency Diseases (PIDDs)
  • Idiopathic Thrombocytopenic Purpura(ITP)
  • Kawasaki Disease(KD)
  • Guillain-Barré Syndrome(GBS)
  • Chronic Lymphocytic Leukemia (CLL)
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • Bone Marrow Transplantation (BMT) – for prevention of graft vs host disease

Storage

  • Store at 2 to 8°C
  • Protect from light
  • Do not freeze

Shelf-life

36 months from the date of manufacture

Product Name

PlasmaGlob


Generic Name

Human Intravenous Immunoglobulin 5%


Strengths Avaliable

5% in 10 mL, 50mL, 100 mL [0.5g, 2.5g, 5g]

Product Description

PlasmaGlob 10 is Normal Human Immunoglobulin, 10% in 50 mL & 100mL for Intravenous use prepared from Indian Human Plasma from healthy voluntary donors, by Cohn Fractionation/ Chromatography process. Each unit of plasma is tested for all mandatory serological markers prescribed by National Regulatory Authority (NRA).

To increase safety profile of PlasmaGlob 10, the plasma used in its manufacturing and final product undergoes extensive testing from various protocols HBsAg, Ab-Ag HIV, anti-HCV by ELISA and for HBV-DNA, HCV-DNA, HAV-RNA, HIV-RNA, Parvovirus B19-DNA by NAT/PCR.

Only the non-reactive plasma units were used for manufacturing of PlasmaGlob. To further improve the margin of safety effective viral inactivation steps like solvent detergent treatment have been integrated into the manufacturing and formulation process. PlasmaGlob has undergone two steps of viral inactivation. As per the regulatory norms and Hemovigilance program, the record of plasma used in manufacturing of PlasmaGlob has been maintained for 10 years.

PlasmaGlob 10 is Glycine stabilized IVIG, tested, developed, and documented in EU associates and other international markets and contains no preservatives.

Indications

  • Primary Immune Deficiency Diseases (PIDDs)
  • Idiopathic Thrombocytopenic Purpura(ITP)
  • Kawasaki Disease(KD)
  • Guillain-Barré Syndrome(GBS)
  • Chronic Lymphocytic Leukemia (CLL)
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • Bone Marrow Transplantation (BMT) – for prevention of graft vs host disease

Storage

  • Store at 2 to 8°C
  • Protect from light
  • Do not freeze

Shelf-life

36 months from the date of manufacture

Product Name

PlasmaGlob 10


Generic Name

Human Intravenous Immunoglobulin 10%


Strengths Avaliable

10% in 50 mL, 100 mL [5g, 10g]

Product Description

PlasmaRAB is a sterile, non-pyrogenic aqueous solution containing not less than 150 I.U./mL of anti-rabies immune globulin (human). PlasmaRAB is supplied in 2mL single dose vial.

The product is assayed with human rabies immunoglobulin reference standard that is calibrated against the WHO International Standard. The product contains at least 95% immunoglobulin G (IgG).

Indications

  • Transient post-exposure prophylaxis of rabies infection
  • To be used only in combination with a rabies vaccine as part of the post-exposure prophylaxis

Storage

  • Store at 2°C to 8°C
  • Do not freeze.

Shelf-life

30 months from the date of manufacture

Product Name

PlasmaRAB


Generic Name

Human Rabies Immune Globulin


Strengths Avaliable

300 I.U. in 2 mL [150 I.U./mL]

Product Description

PlasmaRho-D I.V. is a sterile non-pyrogenic aqueous solution, containing 150 μg /mL (1500 I.U. in 2mL) of immune globulin Anti-D. PlasmaRho-D I.V. is prepared from pooled Human venous plasma with a high content of Anti-D antibodies by ion-exchange column chromatography.

Each unit of plasma and each plasma pool used in the manufacture of this product has been tested and found to be negative / non-reactive to Hepatitis B surface Antigen (HBsAg), anti-HIV I-II and anti-HCV. Additionally, the plasma is tested by NAT method for HAV, HIV, HBV, and HCV and to contain <104 I.U. / mL Parvovirus B-19. Also, the manufacturing process includes a Solvent/Detergent step and Heat-treatment for inactivation of non-enveloped viruses.

Indications

  • Non-splenectomised Rho (D) – positive adults with chronic ITP, children with chronic or acute ITP, and patients with thrombocytopenia secondary to HIV infection
  • Clinical situations requiring an increase in platelet count to prevent excessive haemorrhage

Storage

  • Store at 2°C to 8°C
  • Do not freeze.

Shelf-life

36 months from the date of manufacture

Product Name

PlasmaRho-D I.V.


Generic Name

Human Anti-D Immune Globulin


Strengths Avaliable

300 μg in 2 mL [150 μg /mL]


  • MORE PRODUCTS

Product Description

AlbuMax(Normal Human Albumin 20%) is a sterile highly purified solution of Albumin protein prepared from Human Plasma collected from healthy voluntary donors. AlbuMax contains no preservatives.

To increase safety profile of AlbuMax, the plasma used in its manufacturing and final product undergoes extensive testing of various protocols; HBsAg, Ab-Ag HIV, anti-HCV by ELISA and for HBV-DNA, HCV-DNA, HAV-RNA, HIV-RNA, Parvovirus B19-DNA by NAT. To further improve the margin of safety, effective viral inactivation/removal steps have been integrated into the manufacturing and formulation process.

Indications

  • Hypovolemic Shock
  • Hypoproteinemia
  • Hemorrhagic shock
  • Ascites
  • Burns
  • Plasma Exchange Dialysis

Storage

  • Store between 2°C to 25°C
  • Do not freeze
  • Protect from light

Shelf-life

36 months from the date of manufacture

Product Name

AlbuMax


Generic Name

Human Albumin Solution


Strengths Avaliable

20% in 100 mL


Product Description

VerBumin is Normal Human Albumin for Intravenous use manufactured from Indian Human Plasma. Each unit of plasma is tested for all mandatory serological markers prescribed by National Regulatory Authority (NRA).

VerBumin undergoes heat pasteurization at 60°C for 10-12 hrs. for viral inactivation.

To increase margin of safety, effective steps in extensive testing protocols have been integrated into manufacturing and formulation process to ensure contamination free product from HBsAg, HCV, HIV antibodies and for HBV-DNA, HCV-RNA, HIV-RNA by PCR. As per regulatory norms and Hemovigilance program, the record of plasma used in manufacturing of Verbumin has been maintained for 10 years.

Indications

  • Hypovolemic Shock
  • Hypoproteinemia
  • Hemorrhagic shock
  • Ascites
  • Burns
  • Plasma Exchange Dialysis

Storage

  • Store between 2°C to 25°C
  • Do not freeze
  • Protect from light

Shelf-life

24 months from the date of manufacture

Product Name

VerBumin


Generic Name

Human Normal Albumin


Strengths Avaliable

5% in 100 mL; 20% in 100 mL


Product Description

AsparPeg (PEG Asparaginase) is L-asparaginase (L-Amidohydrolase) that is covalently conjugated to monomethoxypolyethelene glycol (mPEG). L- Asparaginase is a tetrameric enzyme that is produced endogenously by E. coli and consists of identical 34.5 kDa subunits. Approximately 69 to 82 molecules of mPEG are linked to L-Asparaginase; the molecular weight of each mPEG molecule is about 5kDa. The mechanism of action of PEG Asparaginase is thought to be based on selective killing of leukemic cells due to depletion of plasma asparagine.

Indications

  • Indicated as a component of multi agent chemotherapeutic regimen for the treatment of patients with Acute Lymphoblastic Leukemia who are hypersensitive to asparaginase.

Storage

  • Store at 2°C to 8°C
  • Protect from light
  • Do not freeze or shake

Shelf-life

24 months from the date of manufacture

Product Name

AsparPeg


Generic Name

Peg L-Asparaginase


Strengths Avaliable

3750 I.U. in 5mL [750 I.U. / mL]

Product Description

Avangio (Bevacizumab) is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF).

Avangio contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Avangio is produced in a Chinese Hamster Ovary mammalian cell expression system in a nutrient medium and has a molecular weight of approximately 149kDa.

Indications

  • Metastatic Colorectal Cancer (mCRC)
  • Non-squamous Non-small Cell Lung Cancer (NSCLC)
  • Glioblastoma (GBM)
  • Metastatic Renal Cell Carcinoma (mRCC)
  • Persistent, Recurrent, or Metastatic Carcinoma of the Cervix
  • Metastatic Breast Cancer (mBC)

Storage

  • Store at 2°C to 8°C
  • Protect from light
  • Do not freeze or shake

Shelf-life

24 months from the date of manufacture

Product Name

Avangio


Generic Name

Bevacizumab


Strengths Avaliable

100 mg in 4mL, 400 mg in 16mL


Product Description

Ritulasta (Rituximab) is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light and heavy-chain variable region sequences and human constant region sequences. Rituximab is composed of two heavy chains of 451 amino acids and two light chains of 213 amino acids.

Indications

  • Non-Hodgkin’s Lymphoma (NHL)
  • Chronic Lymphocytic Leukemia (CLL)
  • Rheumatoid Arthritis
  • Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

Storage

  • Store at 2°C to 8°C
  • Protect from light
  • Do not freeze or shake

Shelf-life

30 months from the date of manufacture

Product Name

Ritulasta


Generic Name

Rituximab


Strengths Avaliable

100 mg in 10 mL, 500 mg in 50 mL

Product Description

Mobixafor (Plerixafor) is a sterile, preservative-free, clear, colorless to pale yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-use vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to á pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer.

Indications

Mobixafor (Plerixafor) is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilization of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly.

Storage

  • Store at 25°C, excursions permitted to 15°C-30°C

Shelf-life

36 months from the date of manufacture
After opening-
From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Product Name

Mobixafor


Generic Name

Plerixafor


Strengths Avaliable

24 mg in 1.2mL [20mg / mL]

Product Description

Ulipta (Ulinastatin) ) is a serine protease inhibitor that reduces the pro-inflammatory response as a result of sepsis, acute pancreatitis, trauma, or surgery. Ulinastatin for Injection is available as lyophilized powder for reconstitution.

Indications

  • Severe Sepsis (due to infection, trauma, burns or surgery).
  • Mild and severe acute pancreatitis.

Storage

  • Store below 25°C
  • Protect from light

Shelf-life

24 months from the date of manufacture

Product Name

Ulipta


Generic Name

Ulinastatin


Strengths Avaliable

100,000 I.U. in 5 mL [20,000 I.U./mL]


Product Description

Nabexol (Paclitaxel protein-bound particles for injectable suspension) is an albumin-bound form of Paclitaxel with a mean particle size of approximately 130 nanometers. The active agent in Nabexol is paclitaxel, a natural product with antitumor activity. Paclitaxel exists in the particles in a non-crystalline, amorphous state.

Nabexol is supplied as a white to yellow, sterile lyophilized powder for reconstitution with 20mL of 0.9% Sodium Chloride injection prior to intravenous infusion. Each single-use vial contains 100 mg of paclitaxel and approximately 900 mg of human albumin. Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel. Nabexol is free of solvents.

Indications

  • Metastatic Breast Cancer (mBC)
  • Non-Small Cell Lung Cancer (NSCLC)

Storage

  • Controlled room temperature between 20°C to 25°C
  • Protect from light
  • Do not freeze
  • Reconstituted suspension should be stored in the original carton at 2°C to 8°C
  • The reconstituted suspension should be used within 8 hours. Discard any unused portion.

Shelf-life

24 months from the date of manufacture

Product Name

Nabexol


Generic Name

Paclitaxel (protein-bound particles) for Injectable Suspension


Strengths Avaliable

100 mg of paclitaxel in a 50 mL

Product Description

Sorakine (Sorafenib), is a multikinase inhibitor targeting several serine/threonine and receptor tyrosine kinases, is the tosylate salt of sorafenib. Sorafenib tosylate is a white to yellowish or brownish solid, with a molecular weight of 637.0 g/mole. Sorafenib tosylate is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400.

Indications

  • Advanced renal cell carcinoma.

Storage

  • Store protected from light
  • Temperature not exceeding 30°C

Shelf-life

24 months from the date of manufacture

Product Name

Sorakine


Generic Name

Sorafenib Tablets


Strengths Avaliable

200mg [Bottle of 30 and 60 Tablets]

Product Description

DaPhila (Dasatinib) is a kinase inhibitor. The anhydrous free base has a molecular weight of 488.01. DaPhila tablets are white to off-white, biconvex, film-coated tablets containing Dasatinib. The drug substance is insoluble in water and slightly soluble in ethanol and methanol.

Tablets should not be crushed or cut; they should be swallowed whole. DaPhila inhibits the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL.

Indications

  • For the treatment of adults with Chronic Accelerated or Myeloid or Lymphoid blast phase Chronic Myeloid Leukaemia (CML).
  • Treatment of newly diagnosed adults with Chronic Myeloid Leukaemia (CML) in chronic phase
  • Treatment of paediatric patients with Philadelphia Chromosome Positive Chronic Myeloid Leukaemia (Ph+ CML) in chronic phase

Storage

  • Do not stored above 30°C.
  • Keep all medicine out of reach & sight of children.

Shelf-life

Please see manufacturing date and expiry date printed on pack. Do not use the product after the expiry date which is stated on the package. The expiry date refers to the last day of the month.

Product Name

Daphila


Generic Name

Dasatinib Tablets


Strengths Avaliable

20 mg & 50 mg [Bottle of 60 Tablets]

Product Description

AlbuMax-Neo(Normal Human Albumin 20%) is a sterile highly purified solution of Albumin protein prepared from Human Plasma collected from healthy voluntary donors. AlbuMax-Neo contains no preservatives.

To increase safety profile of AlbuMax-Neo, the plasma used in its manufacturing and final product undergoes extensive testing of various protocols; HBsAg, Ab-Ag HIV, anti-HCV by ELISA and for HBV-DNA, HCV-DNA, HAV-RNA, HIV-RNA, Parvovirus B19-DNA by NAT. To further improve the margin of safety, effective viral inactivation/removal steps have been integrated into the manufacturing and formulation process.

Indications

  • Hypovolemic Shock
  • Hypoproteinemia
  • Hemorrhagic shock
  • Ascites
  • Burns
  • Plasma Exchange Dialysis

Storage

  • Store between 2°C to 25°C
  • Do not freeze
  • Protect from light

Shelf-life

36 months from the date of manufacture

Product Name

AlbuMax-Neo


Generic Name

Human Albumin Solution


Strengths Avaliable

20% in 100 mL