NEW DELHI: Drug firm Cadila Healthcare on 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.
Latest posts by MD Team (see all)
- Recordati to seek Canadian approval for kidney disease drug Cystagon - April 17, 2019
- Wockhardt gets zero USFDA observations for Bioequivalence centre - April 16, 2019
- Amgen sets over Rs 15 lakh yearly price for new bone drug Evenity - April 16, 2019