Caplin Steriles Gets USFDA Nod for Nicardipine Injection; Expands US Portfolio with Four ANDA Acquisitions

Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, 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 product will be available in two strengths, 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL) single-dose infusion bags. This formulation is a generic therapeutic equivalent of the Reference Listed Drug (RLD) developed by Hikma International Pharmaceuticals LLC.

Therapeutic Use and Market Potential

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is used for the short-term management of hypertension, particularly when oral administration is not suitable or desirable. According to IQVIA (IMS Health), the product recorded sales of ~USD 68 million in the United States for the 12-month period ending August 2025.

The approval strengthens Caplin Steriles’ position in the US hospital injectable market, which continues to see steady demand for cost-effective, quality-assured alternatives.

Expansion Through ANDA Acquisitions

In addition to the new approval, Caplin Steriles recently acquired four approved ANDA products from third parties, Icatibant Acetate Injection, Paricalcitol Injection, Gatifloxacin Ophthalmic Solution, and Ketamine Hydrochloride Injection.

The combined market size for these products in the US is valued at around USD 121 million, as per IQVIA data for the 12-month period ending August 2025. Caplin plans to introduce these products in the US and other international markets in 2026, thereby broadening its specialty injectable portfolio.

Also Read: Cipla’s New Move in Diabetes Segment with Eli Lilly’s Tirzepatide Launch!

Conclusion

The USFDA approval for Nicardipine Hydrochloride Injection marks a key milestone for Caplin Steriles’ growth trajectory. Together with the strategic acquisition of four additional ANDAs, the company is well-positioned to strengthen its presence in the regulated US market and enhance its long-term revenue potential through a diversified and high-value injectable product pipeline.

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