Sun Pharma bags USFDA nod for generic Mesalamine ER capsules to treat bowel disease
Mumbai: Pharma major, Sun Pharmaceutical Industries Limited, has recently announced that the company has received final approval from US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for generic Mesalamine Extended Release Capsules, 500 mg. The capsules are used to treat bowel disease.
The generic product approval is based on Pentasa Extended Release Capsules, 500mg as a reference product.
As per March 2022 IQVIA Health data, Pentasa Extended Release Capsules, 500mg had annualized sales of approximately US$ 213 million in USA.
Read also: Sun Pharma gets CDSCO committee approval for manufacturing Ranibizumab
Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufacture and market a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies.
It includes generics, branded generics, specialty, complex or difficult to make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs) and Intermediates.
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