Topic: FDA warning letter
India’s Indico Remedies has had a sterile injectables plant blasted in an FDA warning letter for its laissez-faire approach to dealing with consumer complaints.
Another Mylan plant in India has been issued a warning letter.
Gilead is planning its first foreign manufacturing facility, Takeda will develop an IBD drug from Finch while cutting 180 workers at Ariad after the buyout.
The FDA has nailed India's Indoco with a warning letter for a sterile and solid dose plant in Goa because of its concerns over an injected drug.
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.