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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

List of new drugs (r-DNA origin) approved for manufacture and marketing in India during the period Aug, 2023 to Oct, 2023

07-Nov-2023 | NA

Central Drugs Standard Control Organization has issued a list of new drugs (r-DNA origin) approved for manufacture and marketing in India during the period from August 2023 to October 2023. Here are some of the details: M/s Shilpa Biologicals Private Limited Date of Permission: 24-08-2023 Permission No.: MF/BIO/23/000078 Name of the Drug: Adalimumab Drug Substance (Bulk) Indication: NA Dosage Form & Strength: Concentration: 100 mg/ml M/s Enzene Biosciences Ltd. Date of Permission: 29-08-2023 Permission No.: MF/BIO/23/000080 Name of the Drug: Ranibizumab Injection Indication: Neovascular Age-related Macular Degeneration Dosage Form & Strength: Solution for injection in vial, Strength: 10 mg/ml M/s Levim Biotech LLP Date of Permission: 24-08-2023 Permission No.: MF/BIO/23/000076 Name of the Drug: Liraglutide Indication: For the treatment of Type II Diabetes Mellitus Dosage Form & Strength: Solution for Injection in 3 ml cartridge (18mg/3mL), Strength: 10 mg/mL M/s Zenotech Laboratories Limited Date of Permission: 05-10-2023 Permission No.: MF/BIO/23/000089 Name of the Drug: Ranibizumab Indication: Indicated for the treatment of neovascular age-related macular degeneration (AMD) Dosage Form & Strength: Single-use glass vial for intravitreal injections, Strength: 10 mg/ml M/s Gennova Biopharmaceuticals Limited Date of Permission: 27-10-2023 Permission No.: MF/BIO/23/000093 Name of the Drug: Tenecteplase Revised Indication: Tenecteplase (TNK-t-PA) is indicated in thrombolytic treatment of the Acute Ischemic Stroke within 4.5 hrs of the stroke initiation Dosage Form: Powder for injection Strength: 20 mg/10mL Vial Please refer to the attached document for detailed information.

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