Caplin Point gets USFDA’s approval for Ketorolac Tromethamine Injection

20 Sep 2017 Evaluate

Caplin Point Laboratories has received approval from the U.S. Food and Drug Administration (USFDA) of its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection 30mg/mL, a product developed for Cycle Pharmaceuticals. Ketorolac Tromethamine Injection is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.

Ketorolac Tromethamine Injection has been developed at Caplin Point and will be manufactured at Caplin’s FDA approved site. Cycle has selected Virtus Pharmaceuticals, LLC (Virtus) as the importer and distributor of Ketorolac Tromethamine Injection in the U.S.

Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.

 

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