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 ...

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

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

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

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

Indoco Remedies receives USFDA approval for Varenicline Tablets, plans to manufacture at Goa facility, showcasing growth in ...

Lupin receives US FDA tentative approval for raltegravir tablets, USP: Our Bureau, Mumbai Friday, November 8, 2024, 17:45 Hrs [IST] Global pharma major Lupin Limited (Lupin) annou ...

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 ...

PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application Back to video The deficiencies cited in the CRL are classified as ...

Mumbai: Indoco Remedies Ltd. has announced the final approval of the Company's Abbreviated New Drug Application (ANDA) for ...

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 ...