Caplin Steriles Limited (Caplin), a subsidiary of Caplin Point Laboratories Limited, has received final USFDA approval 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 version of the Reference Listed Drug (RLD), DDAVP (desmopressin acetate) Injection (4 mcg/mL), by Nordic Pharma Inc.

Desmopressin Acetate Injection is primarily used to treat central diabetes insipidus, haemophilia A, and von Willebrand disease.

According to IQVIA data, this product category generated approximately $26 million in U.S. sales for the 12-month period ending December 2025.

This marks the 52nd ANDA approval for Caplin Point Laboratories.