Alembic Pharma jumps 8% as it gets final FDA approval on injectable drug

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

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Shares of Alembic Pharmaceuticals soared after the company said it got the US drug regulator’s final approval on the second injectable product from its general sterile facility which was inspected in August.

The drug maker said it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/ml, 30 mg/ml, and 30 mg/ml single dose vials.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Toradol Injection. Ketorolac Tromethamine is indicated for the short-term management of moderately severe acute pain in adult patients.

Ketorolac Tromethamine Injection USP has an estimated market size of $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 the USFDA.

The stock traded up over 8 percent to Rs 663 on the BSE.

Analysts are largely bearish on the stock. Motilal Oswal, ICICI Securities advice to sell the counter while KR Choksey has a ‘hold’ rating.

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