Alembic Pharmaceuticals Announces Second Injectable Product Approval

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the United States 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 drug product (RLD), Toradol Injection, 15 mg/mL, 30 mg/mL and 60 mg/2 mL, from 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 a complete indication.

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 provisional approvals) from the USFDA.

Shares of Alembic Pharmaceuticals Limited last traded on the BSE at Rs. 612.20 from the previous close of Rs. 578.45. The total number of shares traded during the day was 41,426 in over 4,213 trades.

The stock hit an intraday high of Rs. 619.20 and intraday low of 574.90. The net turnover during the day was Rs. 25087088.00.

Source: Stock market bulls

Key words

Final approval
KetorolacTromethamine Injection