India Outlines Plan to Boost Inspections of Drug Facilities - Pharmalot - WSJ

Updated October 7, 2023

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Read the full article: India Outlines Plan to Boost Inspections of Drug Facilities - Pharmalot - WSJ:

"Last year, the FDA conducted 111 inspections in India, up from 98 in 2011 and 59 in 2009, and has issued warning letters to several Indian drug makers. Significantly, the FDA also issued 21 so-called import alerts that allow the FDA to ban products from entering the U.S.

One widely known example is Ranbaxy Laboratories [500359.BY +1.16%], which is prevented from sending products from four of its plants in India and is also operating under a consent decree that requires improvements before the ban can be lifted. Sun Pharmaceuticals [524715.BY +1.46%] recently agreed to buy Ranbaxy for $3.2 billion"

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Sun Pharmaceutical to Buy Ranbaxy in $3.2 Billion Deal - WSJ.com

Sun Pharmaceutical to Buy Ranbaxy in $3.2 Billion Deal - WSJ.com:

"The deal would make Sun Pharma the largest pharmaceutical company in India and the fifth-largest generic drug company in the world. But it would also saddle the Mumbai-based company with the chore of fixing up Ranbaxy's operations and ending restrictions on its U.S. sales.

Before curbs imposed by the U.S. Food and Drug Administration, Ranbaxy earned about 40% of its revenue from the American market. Now, only one Ranbaxy plant, located in the U.S., is producing drugs for U.S. consumption."

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