Caplin Steriles Limited (CSL), a subsidiary of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Desmopressin Acetate Injection USP. The approval covers 4 mcg/mL single-dose vials and 40 mcg/10 mL (4 mcg/mL) multiple-dose vials, a generic equivalent to the reference drug DDAVP (desmopressin acetate) Injection marketed by Nordic Pharma Inc..
Desmopressin Acetate Injection is prescribed for the treatment of haemophilia A, von Willebrand disease and central diabetes insipidus. The medicine helps manage bleeding disorders and regulate urine production in patients requiring hormone-based therapy. According to IQVIA data, the approved strengths of Desmopressin Acetate Injection recorded U.S. sales of approximately $26 million during the 12 months ending December 2025.
The approval strengthens CSL’s presence in regulated markets and expands its portfolio of sterile injectable products. Caplin Steriles operates manufacturing facilities approved by several global regulatory agencies, including USFDA, EU-GMP, ANVISA and INVIMA. The company has filed 54 ANDAs in the United States independently and through partnerships, securing 52 approvals to date, including acquired applications. CSL is also developing a pipeline of more than 55 injectable and ophthalmic products planned for submission over the next four years.
Caplin Point Laboratories Limited, the parent company, focuses on pharmaceutical markets across Latin America and Africa and operates advanced manufacturing facilities covering a wide range of dosage forms. The company has maintained steady growth in revenue, profitability and cash flows over the past 15 years and has been recognised multiple times in the Forbes “Asia’s 200 Best Under a Billion” list. It has also received awards for business excellence and growth from industry organisations.
Another group company, Caplin One Labs Limited, continues to expand operations at its oncology-focused facility in Kakkalur, with several generic and specialty product projects in development for regulated and emerging markets. The unit currently holds five approved ANDAs for injectable and ophthalmic products. The latest approval underscores Caplin Steriles’ strategy to strengthen its pipeline of complex injectable medicines and expand its footprint in global markets, supporting patient access to quality, affordable therapies.
