Caplin Steriles receives USFDA approval for new products

Caplin Steriles Limited, a subsidiary company of Caplin Point Laboratories Limited announced this morning that it has been granted approval from USFDA for its abbreviated new drug application (ANDA) Prochlorperazine Edisylate injection USP, 10 mg/2 ml (5 mg/ml) vials presentations. It is a generic therapeutic equivalent version of (RLD), Compazine injection, of SmithKline Beecham Corporation, USA.  

Prochlorperazine Edisylate injection is an antiemetic drug used for the control of severe nausea and vomiting. According to IQVIATM (IMS Health), Prochlorperazine Edisylate injection had US sales data of approximately $17 million for the 12-month period ending December 2020.  

“We’re glad to receive 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,” says C C Paarthipan, Chairman of Caplin Point Laboratories Limited.  

At 2.49 pm today, the share price of Caplin Point Laboratories Ltd was trading at Rs 507.00, a decrease of 2.82 per cent over its previous day’s closing price of Rs 521.70 on BSE.