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Two Ahmedabad-based pharmaceutical companies on Monday said their products have been granted approvals in the US.
Cadila Healthcare Ltd (Zydus Cadila) has received final approval from the US Food and Drug Administration (USFDA) to market Ranitidine Hcl injection 25 mg/ml. Used in the treatment of peptic ulcers, gastritis and gastroesophageal reflux disease (GERD), Ranitidine Hcl falls in the anti-secretory segment.
The estimated sales in 2012 according to IMS for Ranitidine Hcl injection was $5.4 million, the company said in a statement here, adding the group now has 76 approvals and has so far filed 172 ANDAs since the commencement of the filing process in FY 2003-04.
In another statement, Claris Lifesciences Ltd said it received two Abbreviated New Drug Application (ANDA) approvals for Ondensetron injection in the US.
Ondensetron injection is indicated for prevention of nausea and vomiting. The total addressable market size of the product is estimated at $49 million in the US. The company now has nine ANDAs approved in its name across four molecules. It has a total filing of 30 ANDAs across 20 products.
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