Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) Multiple-Dose Vials. This is the first product approval for oncology injection from F-2 Facility (Oncology Injectable) which recently completed the first USFDA inspection.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Taxol Injection, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL). Paclitaxel Injection USP, has an estimated market size of $26 million for twelve months ending June 2022. Alembic has a cumulative total of 172 ANDA approvals (148 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
