Caplin Point Laboratories’ arm gets USFDA’s final approval for Carboprost Tromethamine Injection

14 Feb 2023 Evaluate

Caplin Point Laboratories’ subsidiary -- Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carboprost Tromethamine Injection USP, 250 mcg/mL Single-dose Vials, a generic therapeutic equivalent version of (RLD), HEMABATE Injection, of Pfizer Inc.

Carboprost Tromethamine Injection USP is an oxytocic, indicated for the treatment of postpartum hemorrhage due to uterine atony. According to IQVIA (IMS Health), Carboprost Tromethamine Injection USP had US sales data of approximately $55 million for the 12-month period ending September 2022.

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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