Zydus Cadila gets USFDA nod for anti-peptic ulcer injection

NEW DELHI: Pharmaceuticals firm Zydus Cadila today said it has received final approval from US health regulator to market generic Ranitidine Hcl (hydroclhoride) injection used in treating peptic ulcers.

The approval from the US Food and Drug Administration (USFDA) is for Ranitidine Hcl injection of strength 25mg/ml, the company said in a filing to the BSE.

Citing IMS data, the company said the estimated sales of Ranitidine Hcl was $5.4 million in 2012.

The injection is used in treatment of peptic ulcers, gastritis, gastroesophageal reflux disease.

The company has now 76 approvals and has so far filed 172 abbreviated new drug applications since the filing process began in 2003-04, it added.

Shares of the company closed almost flat at Rs 774.95 apiece on BSE.