The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
Discussions are likely to centre on how the country can move up the pharmaceutical value chain
Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size
As demand for GLP-1 therapies explodes, India’s drug regulator moves to curb advertising amid rising concerns over misuse, access, and long-term impact
Multi-year CDMO partnership combines AI-led virtual development, precision chemistry and GMP manufacturing to accelerate five high-science APIs across regulated markets
They also differentiated the innovator biologic Semaglutide molecule from newer synthetic or chemical generic versions entering the market
Sugammadex injection is bioequivalent to Merck’s Bridion injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery
Kedar Upadhye has also been appointed as Chief Financial Officer of Biocon Limited
They stressed that while the drug is clinically proven to support weight and blood sugar control, it must be prescribed only after careful patient evaluation and used under strict medical supervision.
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