WuXi Biologics' Four Manufacturing Facilities and Biosafety Testing Center Certified Again by European Medicines Agency for Ten Biologics
Rhea-AI Summary
WuXi Biologics (WXXWY) announced that four of its manufacturing facilities and its Suzhou Biosafety Testing Center in China have received Good Manufacturing Practice (GMP) certificates from the European Medicines Agency (EMA). This certification covers commercial and NDA-ready manufacturing and services for eight biologics. The Suzhou center was certified for services related to ten novel therapies.
The company has a strong track record in quality compliance, having passed 35 global regulatory agency inspections, over 1,250 GMP quality audits by global clients, and more than 145 audits by EU Qualified Persons since 2017. WuXi Biologics currently has 15 GMP-certified drug substance and drug product facilities in its global network.
Positive
- Received EMA GMP certificates for four manufacturing facilities and Suzhou Biosafety Testing Center
- Certified for commercial and NDA-ready manufacturing of eight biologics
- Suzhou center certified for services related to ten novel therapies
- Passed 35 global regulatory agency inspections since 2017
- Completed over 1,250 GMP quality audits by global clients
- Passed more than 145 audits by EU Qualified Persons
- Has 15 GMP-certified drug substance and drug product facilities globally
Negative
- None.
News Market Reaction
On the day this news was published, WXXWY declined 1.40%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Following comprehensive inspections of the company's facilities– specifically MFG1, MFG2, MFG5, and DP1 in Wuxi– EMA GMP certificates were issued for commercial and New Drug Application (NDA)-ready manufacturing and services for eight biologics, an endorsement to the company's capabilities in providing such services for global clients. All of these facilities were previously approved by the EMA and other major regulatory authorities for the development of multiple biologic therapeutics. Furthermore, the company's Suzhou Biosafety Testing Center was once again certified by the EMA to provide services for ten novel therapies, including the eight biologics being manufactured in
WuXi Biologics has a proven track record of strict quality compliance. Since 2017, the company has completed and passed 35 global regulatory agency inspections, more than 1,250 GMP quality audits by global clients, and more than 145 audits by EU Qualified Persons. Currently, WuXi Biologics has 15 GMP-certified drug substance and drug product facilities in its global network.
Dr. Chris Chen, CEO of WuXi Biologics, commented: "We are proud that our facilities have once again been certified by the EMA, reflecting our unwavering commitment to the highest quality standards across the company. Quality audits are crucial to ensuring the safety and efficacy of the global pharmaceutical industry, and WuXi Biologics remains dedicated to enabling our clients in bringing high-quality biologics to patients worldwide."
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
With over 12,000 skilled employees in
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to be an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com.
View original content:https://www.prnewswire.com/news-releases/wuxi-biologics-four-manufacturing-facilities-and-biosafety-testing-center-certified-again-by-european-medicines-agency-for-ten-biologics-302211797.html
SOURCE WuXi Biologics
FAQ
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How many GMP-certified facilities does WuXi Biologics (WXXWY) have in its global network as of August 2024?
