Caplin Point Labs subsidiary gets US FDA nod for Ephedrine Sulfate Injection

Caplin Point Laboratories said that its subsidiary Caplin Steriles has been granted final approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Ephedrine Sulfate Injection.

The approved ANDA is a generic therapeutic equivalent version of the reference listed drug (RLD) AKOVAZ, from Exela Pharma Sciences LLC.

Ephedrine Sulfate Injection USP is indicated for the treatment of clinically important hypotension occurring in the setting of anaesthesia.

According to IQVIA (IMS Health), Ephedrine Sulfate injection USP had US sales of approximately $36 million for the 12-month period ending May 2024.

Caplin Point Laboratories is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company has manufacturing facilities that cater to a complete range of finished dosage forms.

The company's consolidated net profit jumped 19.08% to Rs 121.59 crore on 16.43% increase in revenue from operations to Rs 453.22 crore in Q4 FY24 over Q4 FY23.

The scrip declined 3.59% to currently trade at Rs 1472.65 on the BSE.

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