[ad_1] Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). This approval makes Alembic’s product therapeutically equivalent to the reference listed drug Protonix I.V. for Injection, 40 mg/vial, manufactured by Wyeth Pharmaceuticals LLC. Pantoprazole sodium injection is used for […]
US FDA ends Alembic Pharma’s Vadodara unit inspection with one observation – CNBC TV18
[ad_1] Drug firm Alembic Pharmaceuticals Ltd on Friday (March 7) announced the completion of a scheduled inspection by the United States Food and Drug Administration (FDA) at its bioequivalence facility in Vadodara. The inspection, conducted from March 3-7, 2025, resulted in the issuance of a Form 483 with one procedural observation. “We would like to […]
Alembic Pharma shares jump 5% on final USFDA nod to Seizure treatment drug – CNBC TV18
[ad_1] Shares of Alembic Pharmaceuticals rose nearly 5% on Thursday after the company received final approval from the US Food and Drug Administration (USFDA) for Lamotrigine Extended-Release tablets, which are primarily used in the management of certain types of seizures. This approval adds to Alembic Pharma’s growing portfolio, which now includes 216 ANDA approvals from […]
Alembic Pharma gets USFDA nod for cancer treatment injection – CNBC TV18
[ad_1] Alembic Pharmaceuticals Limited has received the final approval from the US Food & Drug Administration (USFDA) for its Nelarabine Injection. The drug is indicated for treating T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma. Confirming the development in an exchange filing on August 2, the pharma company said it received USFDA’s Abbreviated New Drug […]