Alembic Pharma Gets USFDA Approval for Divalproex Sodium Capsules, 125 mg Kumar Jeetendra | December 20, 2024 Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Divalproex Sodium Delayed-Release Capsules USP, 125 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules, 125 mg, of AbbVie Inc. Alembic …
Alembic Pharma Gets EIR for API-I & II Facility at Panelav Kumar Jeetendra | September 15, 2025 Alembic Pharmaceuticals Limited has received the Establishment Inspection Report (EIR) for the inspection conducted by the US Food and Drug Administration (USFDA) at its API-I and API-II facilities in Panelav. The inspection was carried out between May 26, 2025 and May 31, 2025. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited, a vertically integrated research and …
