Caplin Steriles Gains USFDA Approval for Desmopressin Injection
Filing Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Ltd, has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Desmopressin Acetate Injection USP. This approval covers 4 mcg/mL single-dose vials and 40 mcg/10 mL multiple-dose vials, a generic equivalent of Nordic Pharma Inc.’s DDAVP Injection. The US sales for this product were approximately $26 million for the year ending December 2025. Caplin Steriles has developed and filed 54 ANDAs in the US, with 52 approvals to date.
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Ltd, has secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Desmopressin Acetate Injection USP. The approval pertains to 4 mcg/mL single-dose vials and 40 mcg/10 mL (4 mcg/mL) multiple-dose vials. This product is a generic therapeutic equivalent of the Reference Listed Drug (RLD) DDAVP Injection, 4 mcg/mL, originally developed by Nordic Pharma Inc.
The Desmopressin Acetate Injection is used for treating conditions such as haemophilia A, von Willebrand disease, and central diabetes insipidus. According to IQVIATM (IMS Health), the US sales for Desmopressin Acetate Injection USP, 4 mcg/mL single-dose vials, and 40 mcg/10 mL (4 mcg/mL) multiple-dose vials were approximately $26 million for the 12-month period ending December 2025.
Caplin Steriles Limited has developed and filed 54 ANDAs in the United States, achieving 52 approvals, including acquired ANDAs. The company is also working on a portfolio of over 55 injectable and ophthalmic products, which it plans to file over the next four years. Additionally, Caplin Steriles has multiple products filed and approved in non-US markets, including Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, South Africa, and Saudi Arabia.
The approval from the USFDA marks a significant milestone for Caplin Steriles, enhancing its product offerings in the US market. The company continues to expand its presence in regulated markets with a focus on sterile product manufacturing. Caplin Steriles is approved by several regulatory agencies, including US FDA, EU-GMP, ANVISA, and INVIMA.
Caplin Point Laboratories Ltd is a pharmaceutical company focusing on emerging markets in Latin America and Africa. The company operates state-of-the-art manufacturing facilities that produce a wide range of finished dosage forms. Caplin Point has been recognized on Forbes’ “Asia’s 200 Best Under a Billion” list multiple times and has received awards for its business excellence. The company continues to prioritize high-quality growth in cash flows, profitability, and revenues.