Caplin Point Laboratories Limited has informed the Exchange regarding a press release dated May 14, 2026, titled "Receipt of final approval by our subsidiary, Caplin Steriles Limited, from the USFDA for Foscarnet Sodium Injection.".
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Caplin Point's subsidiary Caplin Steriles has received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Foscarnet Sodium Injection (6000 mg/250 mL Infusion Bag). This is a generic version of the reference listed drug Foscavir Injection from Clinigen Healthcare. The drug is used to treat CMV retinitis in AIDS patients and HSV infections in immunocompromised individuals. According to IQVIA data, the US market for this product was approximately $15 million for the 12-month period ending March 2026. This approval adds to Caplin Steriles' portfolio of 55 ANDA approvals.
This USFDA approval enables Caplin Steriles to launch a generic antiviral injection in the US market, potentially capturing share in a $15 million therapeutic segment. It strengthens the company's sterile injectables portfolio and supports future revenue growth prospects.