"With the strength of our ONE-stop service platform covering antibody, bioconjugation drug substance and drug product
, WuXi Biologies will continue enabling our global partners to develop exciting ADCs to benefit cancer patients worldwide."
The Food and Drug Administration (FDA) has warned the public against the presence of six unregistered drug products
in the market.
SHANGHAI, March 27, 2019 -- STA Pharmaceutical Co., Ltd., (WuXi STA) -- a subsidiary of WuXi AppTec--announces that its new drug product
manufacturing facility in Shanghai Pilot Free Trade Zone has passed its first GMP inspection by the European Medical Products Agency (MPA).
STA Pharmaceutical Co Ltd (WuXi STA) revealed on Tuesday that its new drug product
manufacturing facility in Shanghai Pilot Free Trade Zone has passed the European Medical Products Agency (MPA) GMP inspection.
This will further enhance the quality of APIs before using them in the manufacture of drug products
The Microcell is designed to help bring drug products
to market faster by providing cost-effective, flexible filling capacity; development processes can happen earlier in a product's lifecycle.
The FDA sent inspectors to the facility in Taoyuan in September 2017, and found that the firm failed to establish sound lab procedures for testing drug products
and keeping detailed records.
He pointed out that AAHP said that the draft guidance would not materially affect the majority of homeopathic drug products
in the U.S., given these products' wide margin of safety and manufacturing procedures according to current Good Manufacturing Practices (cGMPs).
quality control was the main reason for registration refusal.
Although compounded drug products
"may benefit certain patients whose medical needs cannot be met by a commercially available or an FDA-approved drug product
," the FDA statement said that "taking compounded drug products
that are essentially copies of a commercially available or approved drug needlessly exposes patients to drug products
that FDA has not evaluated for safety, effectiveness, and quality."
Following the success of the engineering batches, IDT will now move on to the manufacture of exhibit batches of drug product
that will be placed on stability studies.