Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials. This is the second injectable product approval from company’s General Sterile Facility (F-3) which was inspected in August, 2022.
Ketorolac Tromethamine Injection USP has an estimated market size of $59 million for twelve months ending June 2022 according to IQVIA. The company has a cumulative total of 175 ANDA approvals (151 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.
