Caplin Steriles, a subsidiary of Caplin Point Laboratories, has received US drug regulator's approval for prochlorperazine edisylate injection.
Caplin Steriles 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 antiemetic and is indicated for the control of severe nausea and vomiting. According to IQVIA (IMS Health), prochlorperazine edisylate injection had US sales data of approximately $17million for the 12-month period ending December 2020.
C. C. Paarthipan, chairman of Caplin Point Laboratories 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."
Caplin Point Laboratories is a pharmaceutical company. It holds over 2,800 product licenses across the globe, with a dominant position in Latin America. The company is entering into Regulated markets of US, EU, Brazil, Mexico, Australia, with a state-of-the-art manufacturing facility for injectables, already approved by EU-GMP, ANVISA and USFDA.
The company reported 12.3% increase in consolidated net profit to Rs 66.14 crore on 20.2% increase in net sales to Rs 274.39 crore in Q3 FY21 over Q3 FY20.
The scrip fell 1.52% to currently trade at Rs 513.75 on the BSE.
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