Caplin Steriles receives USFDA approval for Carboprost Tromethamine Injection

Caplin Steriles (Caplin), a subsidiary company of Caplin Point Laboratories, 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 IQVIATM (IMS Health), Carboprost Tromethamine Injection USP had US sales data of approximately $55 million for the 12-month period ending Sep 2022.

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