Caplin Point Laboratories has received USFDA approval for its subsidiary, Caplin Steriles Limited, for Nicardipine Hydrochloride Injection. The company also recently acquired approved ANDAs from third parties. The US sales for Nicardipine Hydrochloride Injection were approximately $68 million for the 12-month period ending August 2025. The market size for the acquired products is approximately $121 million.
USFDA Nod for Nicardipine Injection
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories, has received final approval from the USFDA for Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection. The product is available in 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Infusion Bags. It is a generic therapeutic equivalent of Hikma International Pharmaceuticals LLC’s Reference Listed Drug (RLD).
Indication and Market Data
Nicardipine Hydrochloride injection is used for the short-term treatment of hypertension when oral therapy is not feasible. As per August 2025 data, Nicardipine Hydrochloride in Sodium Chloride Injection had US sales of approximately $68 million for the preceding 12-month period.
Acquisition of Approved ANDAs
Caplin Point has also acquired four approved ANDA products from third parties recently:
- Icatibant Acetate Injection
- Paricalcitol Injection
- Gatifloxacin Ophthalmic Solution
- Ketamine Hydrochloride Injection
Market Size of Acquired Products
The collective market size for these acquired products in the US is approximately $121 million for the 12-month period ending August 2025. Caplin Point plans to introduce these products into the US and other markets in 2026.
Source: BSE
