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Clinical Trials
0
0 active
Approvals
5
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
No trial phase data available
No trial data available
FDA
Food and Drug Administration
- Caplin Steriles Limited received final FDA approval for its generic Desmopressin Acetate Injection USP, covering both single-dose and multiple-dose vials for treating bleeding disorders and diabetes insipidus. - The approved product is a therapeutic equivalent to Nordic Pharma's DDAVP injection and enters a market worth approximately $26 million in annual U.S. sales according to IQVIA data. - This approval represents the 52nd ANDA approval for parent company Caplin Point Laboratories, strengthening its position in the U.S. injectable pharmaceutical market.
