Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited (BSE: 524742 | NSE: CAPLIPOINT), 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 covers 4 mcg/mL single-dose vials and 40 mcg/10 mL (4 mcg/mL) multiple-dose vials. The product is a generic therapeutic equivalent of the Reference Listed Drug, DDAVP Injection, 4 mcg/mL, marketed by Nordic Pharma Inc. under NDA 018938.
Desmopressin Acetate Injection is prescribed for the treatment of haemophilia A, von Willebrand disease, and central diabetes insipidus. The drug plays an important role in controlling bleeding episodes and regulating urine production in patients suffering from these conditions. Its clinical relevance in managing rare bleeding disorders and endocrine-related conditions makes it a critical injectable therapy in hospital and specialty care settings.
According to IQVIA (IMS Health) data, the US market for Desmopressin Acetate Injection USP, 4 mcg/mL, reported sales of approximately $26 million for the 12-month period ending December 2025. The approval enables Caplin Steriles to enter this established injectable segment in the United States and strengthens its presence in the regulated US generics market.