NEW DELHI: Drug firm Cadila Healthcare Tuesday said its subsidiary has received approval from the US health regulator to market Ranitidine injection, used to treat stomach and duodenal (intestinal) ulcers.
Liva Pharmaceuticals, a wholly-owned subsidiary of Cadila Healthcare, has received approval from the US Food and Drug Administration (USFDA) for its supplemental abbreviated new drug application, Ranitidine Injection USP, 25 mg/mL, 2 mL single dose vials and 6 mL multi-dose vials, Cadila Healthcare said in a BSE filing.
Cadila Healthcare said the product will be manufactured at Liva Pharma’s manufacturing facility at Vadodara, and is the first product to be approved from this site for marketing in the US.
The company has more than 237 approvals, and has so far filed over 340 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.
