USFDA23 Oct 2025, 02:50 pm
Caplin Point's Subsidiary Receives USFDA Approval for Nicardipine Hydrochloride Injection and Acquires Four ANDAs
AI Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the USFDA for its ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection. The company also acquired four approved ANDA products from third parties: Icatibant Acetate Injection, Paricalcitol Injection, Gatifloxacin Ophthlamic Solution, and Ketamine Hydrochloride Injection. These products have a collective market size of approximately $121 million in the US.
Key Highlights
- Caplin Steriles Limited received USFDA approval for Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection
- The approved product is a generic therapeutic equivalent version of the RLD from Hikma International Pharmaceuticals LLC
- Nicardipine Hydrochloride in Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable
- Caplin acquired four approved ANDA products from third parties: Icatibant Acetate Injection, Paricalcitol Injection, Gatifloxacin Ophthlamic Solution, and Ketamine Hydrochloride Injection
- The collective market size of the acquired products is approximately $121 million in the US