Caplin Point’s arm secures USFDA’s final approval for Desmopressin Acetate Injection

02 Mar 2026 Evaluate

Caplin Point Laboratories’ subsidiary -- Caplin Steriles (Caplin) has secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Desmopressin Acetate Injection USP, 4 mcg/mL single-dose vials and 40 mcg/10 mL (4 mcg/mL) multiple-dose vials. Desmopressin Acetate Injection USP is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DDAVP (desmopressin acetate) Injection, 4 mcg/mL of Nordic Pharma Inc.

Desmopressin Acetate Injection is used to treat conditions like haemophilia A, von Willebrand disease, and central diabetes insipidus, helping to manage bleeding and regulate urine production.

Caplin Point Laboratories is the mid-sized company in India’s pharmaceutical sector to be engaged in the manufacture of APIs, finished formulations, research & development, clinical research, frontend generic presence in Latin America, brand marketing in Francophone Africa and an USFDA approved injectable facility.

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