Three WuXi Biologics Manufacturing Facilities Receive GMP Certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK)

Rhea-AI Summary

WuXi Biologics (2269.HK) has achieved a significant milestone as three of its manufacturing facilities in Wuxi – MFG1, MFG2, and DP5 – received GMP certification from Turkey's regulatory authority TITCK. This marks the company's first GMP inspection and certification from TITCK, following a comprehensive five-day onsite inspection of two monoclonal antibody biologics.

The company has demonstrated strong regulatory compliance with 44 successful regulatory inspections, including 22 from FDA and EMA, and maintains a 100% pass rate for FDA Pre-License Inspections. WuXi Biologics operates 16 GMP-certified facilities globally and has passed over 1,700 GMP quality audits by global clients, including more than 200 EU Qualified Person audits.

Positive

• First successful GMP certification from Turkey's TITCK, expanding market access
• Perfect track record with 100% pass rate for FDA Pre-License Inspections
• Impressive regulatory compliance with 44 successful inspections, including 22 from FDA and EMA
• Strong quality assurance demonstrated by passing over 1,700 GMP client audits

Negative

• None.

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WUXI, China, Sept. 17, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that three of its manufacturing facilities in Wuxi – MFG1, MFG2, and DP5 – have received GMP certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK). This marks the first GMP inspection conducted by Turkey's TITCK at WuXi Biologics. Achieving the certification underscores the company's commitment to upholding stringent international quality standards across its global network.

During the five-day onsite inspection of two monoclonal antibody biologics produced by WuXi Biologics for its clients, the three manufacturing facilities successfully passed TITCK's comprehensive assessment, validating the company's capabilities in providing high-quality services for global clients. All of these facilities have previously received approval from other major regulatory authorities for the development of multiple biologic therapeutics.

WuXi Biologics has consistently demonstrated a proven track record of adherence to the industry's most rigorous quality standards. As of the end of June 2025, it has successfully passed 44 regulatory inspections, including 22 conducted by the FDA and the EMA. The company also holds an industry-leading achievement with a 100% pass rate for Pre-License Inspection (PLI) by the FDA. Additionally, WuXi Biologics has passed more than 1,700 GMP quality audits by global clients, including more than 200 audits by EU Qualified Persons. Currently, the company operates 16 GMP-certified drug substance and drug product facilities within its global network. Its world-class quality and compliance capabilities remain the cornerstone of clients' trust.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are delighted to receive GMP certification from Turkey's TITCK—our first recognition in the Turkish market, and a clear sign of WuXi Biologics' capability to tap into emerging markets. With a deep understanding that quality is crucial to ensuring safety and efficacy in the global pharmaceutical industry, we are steadfast in upholding the highest standards across our entire network. Looking forward, WuXi Biologics will continue building on our first-class quality system and exceptional service capabilities, remaining 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 China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2025, WuXi Biologics is supporting 864 integrated client projects, including 24 in commercial manufacturing.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts, and promote responsible practices that empower the entire value chain. 

For more information about WuXi Biologics, please visit: www.wuxibiologics.com

Contacts

Business
info@wuxibiologics.com

Media
PR@wuxibiologics.com

 

FAQ

What GMP certifications did WuXi Biologics receive from TITCK in September 2025?

Three WuXi Biologics facilities in Wuxi – MFG1, MFG2, and DP5 – received GMP certification from Turkey's TITCK following a five-day inspection of two monoclonal antibody biologics production.

How many regulatory inspections has WuXi Biologics passed as of 2025?

WuXi Biologics has successfully passed 44 regulatory inspections, including 22 conducted by the FDA and EMA, and maintains a 100% pass rate for FDA Pre-License Inspections.

How many GMP-certified facilities does WuXi Biologics operate globally?

WuXi Biologics operates 16 GMP-certified drug substance and drug product facilities within its global network.

What is WuXi Biologics' track record with client GMP audits?

WuXi Biologics has successfully passed over 1,700 GMP quality audits by global clients, including more than 200 audits by EU Qualified Persons.