Caplin Steriles Gets USFDA Approval for Nicardipine Hydrochloride Injection; Acquires Four Approved ANDAs

Chennai, October 23, 2025: Caplin Point Laboratories Limited (NSE: CAPLIPOINT, BSE: 524742) announced that its subsidiary, Caplin Steriles Limited, has secured final approval from the US Food and Drug Administration (USFDA) for Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection in single-dose infusion bags of 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL). The product serves as a generic equivalent of the reference drug marketed by Hikma International Pharmaceuticals LLC.

The injection is recommended for temporary use to treat hypertension when oral treatment is not appropriate. IQVIA data indicates the product generated roughly USD 68 million in US sales for the 12 months ending August 2025.

On 23 October 2025, Caplin Point Laboratories Limited’s share price closed at ₹2,024.90, a decrease of ₹ 5.00 (-0.25%) from its previous close of ₹2,029.90. The shares opened at ₹2,037.90 and traded between ₹2,059.00 and ₹2,015.10 during the day.

Caplin Point Laboratories Limited is a diversified pharmaceutical company with operations across Latin America and Africa. Over the past 15 years, it has consistently demonstrated strong cash flow, profitability, and revenue growth. The company has been featured seven times in Forbes Asia’s 200 Best Under a Billion list during the last decade. It has also received multiple industry accolades, including the Emerging Company of 2018 and the Business Excellence Award 2019 from the Economic Times.

Acquisition of Four Approved ANDAs

The ANDA portfolio that the company has acquired consists of four injectable and ophthalmic products: Icatibant Acetate Injection, Paricalcitol Injection, Gatifloxacin Ophthalmic Solution, and Ketamine Hydrochloride Injection. These products had a combined US market size of around USD 121 million in August 2025.

Strong Pipeline And Global Expansion

Caplin Steriles has prepared and submitted 52 ANDAs in the US, out of which 42 approvals have been received so far, including the four products acquired recently. It is also preparing a pipeline of more than 40 injectable and ophthalmic dosage forms for filing in the next four years.

In addition to the US, the company has product approvals in Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, and Saudi Arabia, reflecting its increasing global presence.

REF: https://nsearchives.nseindia.com/corporate/CAPLINPOINT_23102025145103_Press_Release__sd.pdf

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