Alembic Pharmaceuticals Ltd has secured final approval from the USFDA for its generic Diltiazem Hydrochloride ...

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

Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Diltiazem Hydrochloride ...

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 ...

FDA sets PDUFA Action Date of June 28, 2025 ...

Treatment availability and patient outcomes are critical issues for the pharmaceutical industry, particularly in eye care.

for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg, to market a generic equivalent of Isentress HD ...

Aurobindo Pharma witnessed a nearly 9% surge in consolidated net profit for Q2FY25, reaching Rs 817 crore. This growth was fueled by an 8% rise in con ...

Harmony Biosciences has also filed a suit against MSN Laboratories and its US arm MSN Pharmaceuticals Inc., in the end of 2023 for allegedly infringing its patent by filling an Abbreviated New Drug ...

A new drug application (NDA) has been submitted to the FDA for sunvozertinib in pretreated EGFR exon 20–positive advanced non ...

Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...

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