Alembic Pharma bags USFDA approval for Pain relief injection Ketorolac Tromethamine
Ketorolac Tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain in adult patients.
Vadodara: Drugmaker Alembic Pharma today 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.
This is the second injectable product approval from the company's 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, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL, of Roche Palo Alto, LLC.
Ketorolac Tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain in adult patients.
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 tentative approvals) from the USFDA.
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Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. It is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
Products under International Generics are manufactured across its facilities in Panelav, Karkhadi, and Jarod in Gujarat. Under this vertical, the company also has R&D facilities in Vadodara (Gujarat), Hyderabad (Telangana), and New Jersey (USA).
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