23 Oct 2025 | 5 Mins Read

USFDA Approves Nicardipine Injection for Caplin Subsidiary

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Caplin Steriles Ltd, a subsidiary of Caplin Point Laboratories Ltd, received final approval from USFDA for its Abbreviated New Drug Application for nicardipine hydrochloride in 0.9% sodium chloride injection. The product has estimated US sales of approximately $68 million for the 12-month period ending August 2025. It's also expected to introduce four other approved ANDA products in the US.