Alembic Pharma zooms 6% post receiving USFDA final approval for Ketorolac Tromethamine Injection

3 Nov 2022 , 10:51 AM

Alembic Pharmaceuticals Limited on Thursday has announced that it 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.

Notably, this is the second injectable product approval from Company’s General Sterile Facility (F-3) which was inspected in August, 2022.

In a regulatory filing, the company stated, “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 indicated for the short-term (≤5 days) management of moderately severe acute pain in adult patients. Refer to our label for full indication.”

According to IQVIA data, Ketorolac Tromethamine Injection USP has an estimated market size of US$ 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.

At around 10:53 AM, Alembic Pharmaceuticals Ltd is currently trading at Rs650.55 per share up by Rs38.35 or 6.26% from its previous closing of Rs612.20 per share on the BSE.

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