Topic: FDA warning letter
For the second time in six weeks, Dr. Reddy’s has been rebuffed by the FDA for its efforts to deal with problems outlined in a warning letter two years ago.
WuXi AppTec started IPO prep for core drug R&D, Purdue and Shionogi won approval for a new constipation med, and an Indian CRO's meds were halted by EMA.
The FDA scolded a Singapore maker of eye washes and other consumer products for poor manufacturing processes.
China plans to eliminate major regulatory barriers for foreign drugs, Tessa bought Euchloe for its checkpoint inhibitors, and J&J and Lilly CEOs supported globalization.
A recent FDA warning letter issued to Chinese API maker Jinan Jinda Pharmaceutical Chemistry says the company's efforts to fix issues are still not enough.
An Indian drugmaker whose Mumbai plant got nailed by an FDA warning letter several years ago is again under the gun for making some of the same mistakes at a sterile drug manufacturing plant in India.
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.