WuXi STA’s new drug product manufacturing facility passes first European MPA GMP Inspection

27 Mar 2019

CDMO positioned to empower more customers to develop innovative drugs faster and more efficiently.

STA Pharmaceutical – a subsidiary of WuXi AppTec – has announced that its new drug product manufacturing facility in Waigaoqiao Free Trade Zone of Shanghai has passed its first GMP inspection by the European Medical Products Agency (MPA). The new facility was opened at the end of 2018, and the successful inspection demonstrates the outstanding quality control system and rapid development of WuXi STA’s drug product services.

WuXi STA’s new drug product manufacturing facility passes first European MPA GMP Inspection

In 2017, WuXi STA merged with WuXi AppTec’s Pharmaceutical Development Services unit, realizing a seamless integration of chemistry, manufacturing and control (CMC) services. Two new commercial drug product facilities – in Shanghai and Wuxi City – have come into operation, enabling WuXi STA to support solid dosage drug development from preclinical to commercial, with several Phase III and commercial drug product projects underway.

WuXi STA has received FDA inspections at both its API and advanced intermediate manufacturing facility in Jinshan (Shanghai), and API R&D & manufacturing facility in Changzhou. As a leading global CDMO, WuXi STA has successfully passed inspections by regulatory bodies in the US, Canada, EU, Switzerland, China, Australia and New Zealand to supply APIs and GMP advanced intermediates for partners.

“We are very proud to have passed the European MPA GMP inspection,” commented Ms. Mei Hao, Vice President of Quality at WuXi STA. “We will continue to strengthen our global quality control system to meet the most stringent regulatory requirements and ensure the quality of services to our partners worldwide. It is a key milestone in our efforts to build geographically integrated capabilities for both drug product and substance development and manufacturing.”

“Quality is not just a core competency, it is ingrained throughout our culture at WuXi STA. The new facility passing the MPA’s GMP inspection is further proof of our commitment to the highest possible quality standards. We look forward to empowering more customers to develop innovative drugs faster and more efficiently for the benefit of patients around the world,” said Dr Minzhang Chen, CEO of WuXi STA.



Read More

Related news

New HCP Kit for automated impurity analysis of biotherapeutics

New HCP Kit for automated impurity analysis of biotherapeutics

21 Jun 2019

Ready-to-use immunoassay kit increases analytical output and productivity in bioprocess workflows.

Read more 
Sanofi and Google to develop new healthcare Innovation Lab

Sanofi and Google to develop new healthcare Innovation Lab

20 Jun 2019

Collaboration aims to change how Sanofi develops new treatments and will focus on to better understand patients and diseases, to increase Sanofi’s operational efficiency, and to improve the experience of Sanofi’s patients and customers.

Read more 
Catalent to purchase BMS manufacturing facility

Catalent to purchase BMS manufacturing facility

19 Jun 2019

Customers to have access to state-of-the-art sterile biologics fill/finish and oral solids manufacturing and packaging platforms.

Read more 
Inaugural Bio Integrates conference highlights industry's inefficiency in developing products

Inaugural Bio Integrates conference highlights industry's inefficiency in developing products

18 Jun 2019

Industry leaders give voice to issues and trends shaping the biotech sector, including the importance of collaboration.

Read more 
Colorcon launches Opadry Enteric for use with hydro-alcoholic media

Colorcon launches Opadry Enteric for use with hydro-alcoholic media

17 Jun 2019

A fully formulated one-step system providing simple preparation and ease-of-use for film coating.

Read more 
SenzaGen granted its first patent for GARD potency biomarker test

SenzaGen granted its first patent for GARD potency biomarker test

16 Jun 2019

Company can now offer an animal-free test method to quantify the strength of an allergenic effect.

Read more 
Affordable measles and rubella vaccines using NevoLine manufacturing platform

Affordable measles and rubella vaccines using NevoLine manufacturing platform

14 Jun 2019

Univercells' propriety bioproduction platform has already proven success.

Read more 
Leaf Expression Systems launches first line of Hypertrans research products

Leaf Expression Systems launches first line of Hypertrans research products

13 Jun 2019

Plant-expression deal for difficult to produce proteins, vaccines, metabolites and natural proteins.

Read more 
Clinical supply milestone reached for triple-negative breast cancer treatment

Clinical supply milestone reached for triple-negative breast cancer treatment

12 Jun 2019

PhoenixMD and WuXi STA have produced a multikilogram drug supply for PMD-026 under GMP manufacturing practices.

Read more 
Combining IT and OT software to solve manufacturing’s most frequent challenges

Combining IT and OT software to solve manufacturing’s most frequent challenges

11 Jun 2019

PTC and Rockwell Automation combine technologies to accelerate customers’ digital transformation initiatives.

Read more