Caplin Steriles Limited (CSL), a wholly owned subsidiary of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Foscarnet Sodium Injection (6000 mg/250 mL Infusion Bag). The approval enables the company to market the generic version of Foscavir Injection in the United States.
The approved product is therapeutically equivalent to the reference listed drug manufactured by Clinigen Healthcare Ltd and is used in the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS as well as herpes simplex virus (HSV) infections in immunocompromised individuals. The approval marks another significant milestone in Caplin Steriles’ growing portfolio of regulated-market injectable products and further strengthens the company’s position in the sterile pharmaceutical manufacturing segment.
According to IQVIA data, the US market for Foscarnet Sodium Injection generated sales of approximately USD 15 million during the twelve-month period ending March 2026. Industry analysts believe demand for antiviral injectable therapies continues to remain stable due to ongoing treatment requirements in immunocompromised patient populations.
Caplin Steriles stated that the approval reflects the company’s sustained focus on expanding its presence in the US pharmaceutical market through a combination of complex injectables, ophthalmic products, and specialty formulations. The company has steadily increased its regulatory footprint over the past several years through investments in manufacturing infrastructure, product development, and compliance systems. CSL currently operates manufacturing facilities approved by major international regulatory agencies, including the USFDA, EU-GMP, ANVISA, and INVIMA.
Caplin Steriles has developed and filed 54 ANDAs independently and in partnership with other organizations for the US market. With the latest approval, the company now holds 55 approvals, including acquired ANDAs, further strengthening its pipeline in regulated pharmaceutical markets.
The company is also actively developing a portfolio of more than 55 injectable and ophthalmic products, including both simple and complex formulations, that are expected to be filed over the next four years. These products are intended to support the company’s long-term strategy of expanding its presence across highly regulated international markets.
In addition to the United States, Caplin Steriles has filed and received approvals for multiple pharmaceutical products in markets such as Australia, Canada, Mexico, Chile, Hong Kong, Malaysia, the UAE, Saudi Arabia, and South Africa. Parent company Caplin Point Laboratories Limited has built a strong business model focused primarily on emerging markets in Latin America and Africa. The company manufactures a wide range of finished dosage forms through advanced manufacturing facilities and has demonstrated consistent financial growth over the past fifteen years.
Caplin Point has received several recognitions for its performance and business growth, including repeated inclusion in Forbes Asia’s “200 Best Under a Billion” list and awards for emerging business excellence from leading industry organizations. The company’s expansion strategy has increasingly focused on regulated markets and specialty product categories through subsidiaries such as Caplin Steriles and Caplin One Labs Limited (COL).
Caplin One Labs, which operates an oncology-focused manufacturing unit in Kakkalur, Tamil Nadu, is currently in its second year of operations and is engaged in developing generic and specialty pharmaceutical products for both regulated and semi-regulated markets. The unit currently holds five approved ANDAs for injectable products and continues to work on additional development projects across oncology and specialty therapeutic categories.
