The pharmaceutical company said that this is the second injectable product approval from its 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 of Roche Palo Alto, LLC (Roche).

Ketorolac Tromethamine is indicated for the short-term (less than or equal to 5 days) management of moderately severe acute pain in adult patients.

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

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

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

The company reported a consolidated net loss of Rs 65.88 crore in Q1 FY23 as against a net profit of Rs 164.52 crore posted in Q1 FY22. Net sales fell 4.8% year on year to Rs 1,262.14 crore in the quarter ended 30 June 2022.