Caplin Point’s arm gets USFDA’s approval for Nicardipine Hydrochloride in Sodium Chloride Injection

23 Oct 2025 Evaluate

Caplin Point Laboratories’ Subsidiary -- Caplin Steriles has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection, 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Infusion Bags, a generic therapeutic equivalent version of the 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. 

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 the mid-sized company in India’s pharmaceutical sector to be engaged in the manufacture of APIs, finished formulations, research & development, clinical research, frontend generic presence in Latin America, brand marketing in Francophone Africa and an USFDA approved injectable facility. 


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