CAPLIN STERILES GETS USFDA APPROVAL FOR PROCHLORPERAZINE EDISYLATE INJECTION

Chennai, April 23, 2021: 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) Prochlorperazine Edisylate Injection USP, 10 mg/2 mL (5 mg/mL) Vials presentations, a generic therapeutic equivalent version of (RLD), COMPAZINE Injection, of SmithKlineBeecham Corporation, USA.

Prochlorperazine Edisylate Injection is an antiemetic and is indicated for the control of severe nausea and vomiting. According to IQVIA TM (IMS Health), Prochlorperazine Edisylate Injection had US sales data of approximately $17 million for the 12-month period ending Dec 2020.

Mr. C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented “We’re glad to receive 3 product approvals within a short period of time. All input materials for the launches have been secured and we’re working on the launch batches shortly.”