Alembic receives USFDA final approval for Nifedipine Extended-Release Tablets

Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022

Alembic receives USFDA final approval for Cyclophosphamide Capsules

Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.

Alembic receives USFDA approval for Ketorolac Tromethamine Injection

Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients

Alembic receives USFDA approval for Mesalamine ER Capsules

Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.

Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP

This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.

Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets

Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA

Granules India receives ANDA approval for Loperamide Hydrochloride and Simethicone Tablets

Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP

he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).

Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).

Alembic receives USFDA tentative approval for Dasatinib tablets

Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive