Press release regarding receipt of final approval by our subsidiary, Caplin Steriles Limited, from USFDA, for Foscarnet Sodium Injection
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Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories, has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Foscarnet Sodium Injection (6000 mg/250 mL Infusion Bag). This is a generic version of Foscavir Injection from Clinigen Healthcare Ltd, used to treat CMV retinitis in AIDS patients and HSV infections in immunocompromised individuals. According to IQVIA data, this product had US sales of approximately $15 million for the 12-month period ending March 2026. The approval allows Caplin Steriles to launch this generic injectable in the US market.
This approval enables Caplin Point's subsidiary to enter the US generic antiviral injectable market worth $15 million annually, potentially adding new revenue streams from US sales. The company's expanding US ANDA portfolio (55 approvals so far) continues to strengthen its regulated market presence.