Caplin Steriles gets USFDA nod for hypertension injection
Chennai: Caplin Steriles Limited, a Subsidiary Company 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) 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.
The product is 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.
Caplin had also acquired the following four approved ANDA products in the recent months from third parties:
o Icatibant Acetate Injection
o Paricalcitol Injection
o Gatifloxacin Ophthlamic Solution
o 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.
Caplin Steriles Limited is a growing sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles Limited has developed and filed 52 ANDAs in the US on its own and with partners (including four ANDAs so far acquired from third parties), with 42 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products that it intends to file over the next 4 years.
The company also has multiple products filed with several approvals in non-US markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, Saudi Arabia etc.
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