Caplin Point Laboratories Limited has informed the Exchange regarding a press release dated February 28, 2026, titled "Receipt of final approval by our Subsidiary, Caplin Steriles Limited, from the USFDA for the Desmopressin Acetate Injection USP".
CAPLIPOINT · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Awaiting price reaction for this filing.
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories, has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Desmopressin Acetate Injection USP, in 4 mcg/mL single-dose and 40 mcg/10 mL multiple-dose vials. This is a generic equivalent of Nordic Pharma's DDAVP injection, used to treat haemophilia A, von Willebrand disease, and central diabetes insipidus. The US market for this product was approximately $26 million for the 12-month period ending December 2025, according to IQVIA. Caplin Steriles has now secured 52 approvals out of 54 ANDAs filed in the US, with plans to file 55+ more injectable and ophthalmic products over the next four years.
This approval strengthens Caplin Steriles' US injectables portfolio and opens up a new revenue stream from a $26 million US market opportunity. While not transformative on its own, it adds to a growing pipeline of USFDA approvals and supports the company's expansion into regulated markets, which is positive for long-term growth.