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Caplin Point Laboratories’ arm gets USFDA approval for Foscarnet Sodium injection

15 May 2026 Evaluate

Caplin Point Laboratories’ subsidiary -- Caplin Steriles (CSL) has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Foscarnet Sodium Injection (6000 mg/250 mL Infusion Bag), a generic therapeutic equivalent version of the Reference Listed Drug (RLD) Foscavir Injection from Clinigen Healthcare.

Foscarnet Sodium Injection is an antiviral medication used to treat CMV retinitis in AIDS patients and HSV infection in immunocompromised individuals. According to IQVIA (IMS Health), Foscarnet Sodium Injection, (6000 mg/250 mL Infusion Bag) had US sales of around $15 million for the 12-month period ending March 2026.

Caplin Point Laboratories is the mid-sized company in India’s pharmaceutical sector to be engaged in the manufacture of APIs, finished formulations, research & development, clinical research, frontend generic presence in Latin America, brand marketing in Francophone Africa and an USFDA approved injectable facility.


Peers
Company Name CMP
Sun Pharma. Inds. 1853.00
Dr. Reddys Labs. 1200.40
Cipla 1404.00
Lupin 2098.00
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