Alembic Pharmaceuticals announces USFDA Final Approval for Docetaxel Injection USP Kumar Jeetendra | March 1, 2023 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials. The approved ANDA is therapeutically …
Alembic Pharmaceuticals announces USFDA Final Approval for Fluorouracil Injection USP Kumar Jeetendra | March 6, 2023 Alembic Pharmaceuticals Limited (Alembic) today announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the Reference Listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 …
Alembic Pharma announces Brexpiprazole tablets USFDA Tentative Approval Kumar Jeetendra | March 10, 2023 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), …
Alembic Pharma announces Brimonidine Tartrate Ophthalmic Solution USFDA Final Clearance Kumar Jeetendra | March 31, 2023 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brimonidine Tartrate Ophthalmic Solution, 0.15%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Alphagan P Ophthalmic Solution, 0.15%, of AbbVie Inc. Brimonidine Tartrate …
Alembic Pharmaceuticals Received 8 USFDA Approvals in Q3FY24 Kumar Jeetendra | January 2, 2024 Alembic Pharmaceuticals Limited (Alembic) announced that it has received US Food & Drug Administration (USFDA) approvals on eight of its Abbreviated New Drug Application (ANDA) in Q3FY24. The Company has received five final approvals that includes Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg and 1,600 mcg, Dapsone gel, 7.5%, Fluorouracil …
Dr. Reddy’s Duvvada Formulations Manufacturing Facility Receives USFDA EIR Kumar Jeetendra | August 13, 2024 Microbioz India, August 13th, 2024– Dr. Reddy’s Laboratories has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its formulations manufacturing facility in Duvvada, Visakhapatnam, a remarkable regulatory achievement. The issuance of the EIR indicates that an earlier inspection has been completed and the factory is meeting strict regulatory …
Alembic Pharmaceuticals announces USFDA Final Approval for Nelarabine Injection Kumar Jeetendra | August 13, 2024 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nelarabine Injection, 250 mg/50 mL (5 mg/mL) (Single-Dose Vial). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Arranon Injection, 250 mg/50 mL …
Revolutionizing Infectious Disease: Dr. Paul’s Journey Kumar Jeetendra | May 12, 2025 In this captivating episode of our podcast series, we feature the world-renowned microbiologist, inventor, and thought leader in anti-infectives and infectious disease R&D, Dr. Maneesh Paul. Key Highlights: The story of Enmetazobactam – India’s first indigenously developed anti-infective and its journey from concept to global approvals (DCGI, USFDA, UKMHRA, EMA). Aspects of AMR, Planetary Health, …
