Topic: FDA warning letter
Fosun Pharma and Shanghai Pharma were said to be interested in buying Stada, Daiichi struck a pain drug R&D deal with Heptares, and Sun Pharma unloads one FDA ban.
The FDA last month issued a warning letter to Pfizer for a sterile injectables plant in Kansas. Now the FDA has posted details of the inspection that led to the letter.
Placing a company on the FDA import alert list does not guarantee its products won't get into the U.S., as a recent warning letter shows.
The FDA said in a warning letter that an Indian API maker had not ensured that water it gets from a nearby river is sanitary before using it to make its products.
Sun Pharma has worked its way out from underneath an FDA ban on a plant it got in its 2015 buyout of Ranbaxy Laboratories.
Wockhardt was hit with a seventh FDA warning letter, China's FDA chief pledged to speed up approvals of foreign drugs, and an Indian court ruled on patent cases concerning copycats of Herceptin and two on-patent Bayer blockbusters.
India’s Wockhardt, which now has a record seven FDA warning letters for its plants on three continents, appears to be reaching a breaking point with the agency.
India’s Megafine Pharma has received its second FDA warning letter in 10 months, this one for an API intermediates plant in India.
Wockhardt has received an untitled letter for a sterile injectables plant in India that Wockhardt is trying to get approved by the FDA to sell into the U.S.
Novartis may face more furor in Korea, Astellas will develop a Prevnar rival with Affinivax, and Lilly and Chi-Med's colorectal cancer med aims for an NDA in China.