Caplin Steriles, a subsidiary of Chennai-based Caplin Point Laboratories Ltd, today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) Carboprost Tromethamine Injection USP, 250 mcg/mL single-dose vials from the United States Food and Drug Administration (USFDA).
Carboprost Tromethamine is a generic therapeutic equivalent version of (RLD), HEMABATE Injection, of Pfizer Inc. Carboprost Tromethamine is used to treat severe bleeding after childbirth (postpartum). It is also used to produce an abortion by causing uterine contractions.
CC Paarthipan, Chairman of Caplin Point Laboratories Ltd, said the company has got the approval for an important product, which is also slightly complex in nature, especially in a vial presentation. “We are expecting 2-3 more approvals in the coming few months, as we look to expand our footprint in the US,” he said.
Caplin Point Laboratories was trading at ₹698.60 apiece on NSE, down by 0.84 per cent from the previous day’s close. The stock hit an intraday high of ₹709.95 per share.