Caplin Point gets USFDA approval for Nicardipine Hydrochloride injection

Caplin Point Laboratories said that it has received final approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection.

The said drug is equivalent to reference listed drug (RLD) 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), Nicardipine Hydrochloride in Sodium Chloride injection had US sales of approximately $68 million for the 12-month period ending August 2025.

The company recently acquired the four approved ANDA products, Icatibant Acetate Injection, Paricalcitol Injection, Gatifloxacin Ophthlamic Solution and Ketamine Hydrochloride Injection from third parties.

According to IQVIA (IMS Health), the collective market size for the above products in the US is approximately $121 million for the 12-month period ending August 2025. These products will be introduced into US and other markets in 2026.

Caplin Point Laboratories is a pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company also has a growing presence in the regulated markets such as US through its subsidiary Caplin Steriles and Caplin Steriles USA Inc.

The company reported an 11.2% year-on-year (YoY) increase in revenue from operations to Rs 510.2 crore and a 20.7% YoY rise in profit after tax (PAT) to Rs 150.8 crore in Q1 FY26.

The scrip declined 1.18% to Rs 2002.40 on the BSE.

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