Chennai, February 14, 2023: Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT) 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, 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.
Mr. 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”