Caplin Point subsidiary secures USFDA approval for nicardipine injection, expands US portfolio

Drug firm Caplin Point Laboratories Ltd on Thursday (October 23) said its subsidiary Caplin Steriles Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for nicardipine hydrochloride in 0.9% sodium chloride injection.

The approval covers 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL) single-dose infusion bags, which are therapeutic equivalents to the Reference Listed Drug from Hikma International Pharmaceuticals LLC.

Nicardipine hydrochloride in 0.9% sodium chloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. According to IQVIA (IMS Health), the product had US sales of approximately $68 million for the 12-month period ending August 2025.

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In addition to this approval, Caplin Steriles has recently acquired four approved ANDA products from third parties — Icatibant Acetate injection, Paricalcitol injection, Gatifloxacin Ophthalmic Solution, and Ketamine Hydrochloride injection.

IQVIA data indicates that the combined market size for these products in the US stood at approximately $121 million for the 12-month period ending August 2025. The company stated that these newly acquired products are planned to be introduced into the US and other markets in 2026.

Shares of Caplin Point Laboratories Ltd ended at ₹2,024.90, down by ₹5.00, or 0.25%, on the BSE.

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