Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories, secured final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Desmopressin Acetate Injection USP. This generic product is a therapeutic equivalent to DDAVP Injection. The approved product comes in single-dose and multiple-dose vials and targets markets treating haemophilia A and diabetes insipidus. US sales for the referenced product were approximately $26 million for the 12 months ending December 2025.
USFDA Final Approval Secured by Subsidiary
Caplin Point Laboratories Limited announced on February 28, 2026, that its subsidiary, Caplin Steriles Limited (CSL), has received the final approval from the United States Food and Drug Administration (USFDA).
The approval pertains to the Abbreviated New Drug Application (ANDA) for Desmopressin Acetate Injection USP. This generic formulation is positioned as a therapeutic equivalent to the Reference Listed Drug (RLD), DDAVP (desmopressin acetate) Injection, marketed by Nordic Pharma Inc. (NDA 018938).
Product Details and Market Potential
The approved product will be available in two configurations:
- 4 mcg/mL single-dose vials
- 40 mcg/10 mL (4 mcg/mL) multiple-dose vials
Desmopressin Acetate Injection is clinically used for managing conditions such as haemophilia A, von Willebrand disease, and central diabetes insipidus.
Market intelligence indicates a significant opportunity, as the sales for the equivalent US product reached approximately $26 million for the 12-month period concluding in December 2025.
Company Performance and CSL Capabilities
Caplin Point Laboratories has demonstrated consistent high-quality growth in cash flows, profitability, and revenues over the past 15 years, having been featured on Forbes “Asia’s 200 Best Under a Billion” list seven times.
Caplin Steriles Limited (CSL) is noted as a fast-growing sterile product manufacturer approved by major global agencies including the US FDA, EU-GMP, ANVISA, and INVIMA.
CSL has a robust pipeline, having filed 54 ANDAs in the USA, securing 52 approvals to date. Furthermore, CSL is actively developing a portfolio of 55+ simple and complex Injectable and Opthalmic products intended for filing over the next four years.
Other Subsidiaries
The announcement also noted the progress of Caplin One Labs Limited (COL), which is in its second year of operation at its oncology unit in Kakkalur. COL currently holds 5 approved ANDAs for Injectable and Opthalmic products, targeting both regulated and other markets.
Source: BSE
