This is the company’s second injectable product approval for its General Sterile Facility. Earlier this week, Alembic Pharma announced that its first injectable product from its General Sterile Facility - the Glycopyrrolate Injection USP – had been approved by the US regulator.
The pharmaceutical company received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, single-dose vials. The injection is used for short-term or less than five days of management of moderately severe acute pain in adults.
The Ketorolac Tromethamine Injection USP has an estimated market size of $59 million for 12 months ending June 2022, according to clinical research firm IQVIA.
The company will be considering its September quarter results on November 11.
