Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic ...

Alembic has a cumulative total of 218 ANDA approvals (191 final approvals and 27 tentative approvals) from USFDA, it added.

Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem ...

for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. The deficiencies cited in the CRL are ...

In a complete response letter, the FDA cited minor deficiencies related to drug substance, product, manufacturing and ...

for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg. Raltegravir Tablets USP, 600 mg are indicated ...

Intra-Cellular Therapies (ITCI) stock gains as the company raised outlook for its lead product Caplyta after better than ...

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Diltiazem Hydrochloride extended-release capsules indicated for the treatment of ...

PharmaTher Holdings Ltd. (the "Company” or "PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a ...