Chennai, Oct 23rd , 2025: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted 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 IQVIATM (IMS Health), Nicardipine Hydrochloride in Sodium Chloride Injection had US sales of approximately $68 million for the 12-month period ending August 2025.
Caplin had also acquired the following four approved ANDA products in the recent months from third parties:
- Icatibant Acetate Injection
- Paricalcitol Injection
- Gatifloxacin Ophthlamic Solution
- Ketamine Hydrochloride Injection
According to IQVIATM (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.