Caplin Steriles gets USFDA nod for Carboprost Tromethamine Injection
Carboprost Tromethamine Injection USP is an oxytocic, indicated for the treatment of postpartum hemorrhage due to uterine atony.
Chennai: Caplin Steriles Limited (Caplin), a subsidiary Company of Caplin Point Laboratories Limited, 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.
The product is 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 Sep 2022.
C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented “We’re pleased to receive approval for an important product which is also slightly complex in nature especially in a Vial presentation. We’re expecting 2-3 more approvals in the coming few months, as we look to expand our footprint in the US”
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