Alembic Pharmaceuticals Limited 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 our General Sterile Facility (F-3) which was inspected in August, 2022. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Toradol Injection, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL, of Roche Palo Alto, LLC (Roche).

Ketorolac Tromethamine is advised for short-term (≤5 days) management of moderately severe acute pain in adult patients.

Ketorolac Tromethamine Injection USP has an estimated market size of US $59 million for twelve months ending June 2022 according to IQVIA.

Alembic has a cumulative total of 175 ANDA approvals (151 final approvals and 24 tentative approvals) from USFDA.