WuXi Manufacturing Facility Passes FDA Inspection
Nov 04, 2013
The CRO/CMO WuXi PharmaTech, reports that its that its small-molecule API and advanced intermediate manufacturing facility of WuXi’s wholly owned subsidiary Shanghai SynTheAll Pharmaceutical (STA) completed a general GMP and pre-approval inspection from FDA with no Form 483 issued.
Source: WuXi PharmaTech
Columnists
Outsourcing
Novasep to Manufacture Celladon's Mydicar API
Novasep has entered into an agreement with Celladon to provide scale-up and pre-validation studies for the drug substance for MYDICAR.
SGS Adds Amino Acid Analysis at German Facility
SGS Life Science Services adds analytical methods to identify amino acid impurities in bio/pharmaceutical manufacturing at facility in Germany.
PBOA Supports Legislation to Protect FDA User Fees
The Pharma & Biopharma Outsourcing Association announced its support of legislation that would preserve FDA user fees from sequestration.
Webcasts
- Enhancing Quality and Process Efficiency Using Continuous Manufacturing Technology for Drug Substance and Drug Product
- Safe and Cost-Effective Capsule Filling for Pre-Clinical and First-in-Man Studies
- Maximizing Roller Compaction Benefits with Proper Excipient Selection
- Developing a Comprehensive Tool Kit for Microbial Identification
Sponsored Links
