Caplin Steriles Secures USFDA Approval for Foscarnet Sodium Injection
Caplin Steriles Limited (CSL), a subsidiary of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA). The approval is for the Abbreviated New Drug Application (ANDA) Foscarnet Sodium Injection (6000 mg/250 mL Infusion Bag). This approval designates the product as a generic therapeutic equivalent version of the Reference Listed Drug (RLD) Foscavir Injection from Clinigen Healthcare Ltd.Foscarnet Sodium Injection is an antiviral medication utilized to treat CMV retinitis in AIDS patients and HSV infection in immunocompromised individuals.
According to IQVIA TM (IMS Health) data, the market performance for Foscarnet Sodium Injection (6000 mg/250 mL Infusion Bag) was notable, reporting US sales of approximately $15 million for the 12-month period ending March 2026.
| Entity | Parent Company | USFDA Status | Product Details |
|---|---|---|---|
| Caplin Steriles Limited (CSL) | Caplin Point Laboratories Limited | Final Approval Granted | Foscarnet Sodium Injection (6000 mg/250 mL Infusion Bag) |
| RLD Drug | Clinigen Healthcare Ltd. | Reference Listed Drug | Foscavir Injection (NDA 020068) |
Company Overviews
Caplin Point Laboratories Limited is described as a fast-growing pharmaceutical company, focusing predominantly on emerging markets in Latin America and Africa. The company operates state-of-the-art manufacturing facilities catering to a complete range of finished dosage forms and has maintained consistent high quality growth in cash flows, profitability, and revenues over the last 15 years. Caplin Point has been featured on the Forbes 'Asia's 200 Best Under a Billion' list seven times in the last ten years.CSL, the subsidiary, is a rapidly growing sterile product manufacturing company. It has received approvals from several regulatory bodies, including the US FDA, EU-GMP, ANVISA, and INVIMA. CSL has developed and filed 54 ANDAs in the USA on its own and with partners, achieving 55 approvals in total, including acquired ANDAs. Furthermore, CSL is expanding its portfolio with over 55 simple and complex Injectable and Opthalmic products planned for filing over the next four years. The company also maintains multiple products approved in non-US markets, including Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, South Africa, and Saudi Arabia.
Additionally, Caplin One Labs Limited (COL), another subsidiary, is in its second year of operations at its oncology unit in Kakkalur. COL is actively engaged in multiple projects for both generic and specialty products for regulated and non-regulated markets, holding five approved ANDAs for Injectable products.
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Listing Details:
| Exchange | Scrip Code |
|---|---|
| NSE | CAPLIPOINT |
| BSE | 524742 |
CAPLIPOINT Stock Price Movement
Today, Caplin Point Laboratories Limited shares surged by 9.89% to close at ₹2024.00, achieving a substantial daily gain of ₹182.20. The stock traded heavily today, settling at a total volume of 2.27 million shares.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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