India Pharma Outlook Team | Tuesday, 07 October 2025
Biocon Pharma Limited which is its fully controlled subsidiary along with Carnegie Pharmaceuticals LLC has been given approval by the US Food and Drug Administration (USFDA) to file the Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg.
Rifaximin is a rifamycin-class antibacterial that is both preventative and curative, thus the drug is indicated as the first choice for the reduction of the over hepatic encephalopathy (HE) recurrence risk and the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
By the characterized symptoms of abdominal pain, bloating, and irregular bowel habits, which are usually accompanying an occasional symptoms of diarrhea, IBS-D has been identified as a very common gastrointestinal disorder of the large intestine. The temporary approval by the USFDA is a great leap for Biocon Pharma because it will now be possible to have access to the different kinds of generic therapies in the US market.
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Biocon Limited, a publicly traded company since 2004, is one of the top biopharmaceutical companies in the world with an extensive portfolio of the latest biologics, biosimilars, and highly complex small molecule APIs. In the past, the company has effectively launched a large variety of innovative products in India, the United States, Europe, and various other international markets.
Apart from biologically and chemically, Biocon has been using the partnerships as a platform to enter into the global market of generic drugs to extend their portfolio, cater to their patients in developed countries, and make drugs available to them at affordable prices.
