Caplin Point Laboratories said that its subsidiary Caplin Steriles received final approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Carboprost Tromethamine Injection USP.
The said drug is generic therapeutic equivalent to the reference listed drug (RLD), HEMABATE Injection, of Pfizer Inc.Carboprost Tromethamine Injection 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.
C. C. Paarthipan, chairman of Caplin Point Laboratories 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."
Caplin Point Laboratories is engaged in the business of pharmaceuticals - producing, developing and marketing wide range of generic formulations and branded products and exporting to overseas market.
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The company's consolidated net profit jumped 30.1% to Rs 97.48 crore on 14.1% rise in net sales to Rs 372.07 crore in Q3 FY23 over Q3 FY22.
The scrip declined 1.12% to Rs 699.25 on the BSE.
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