Caplin Steriles Ltd receives USFDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection

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 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.

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 2031.55 as compared to the previous close of Rs. 2011.15. The total number of shares traded during the day was 2846 in over 483 trades.

The stock hit an intraday high of Rs. 2035.00 and intraday low of 2005.05. The net turnover during the day was Rs. 5774954.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 Pharmaceuticals CaplinSteriles USFDA ANDA Approval