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Three WuXi Biologics Manufacturing Facilities Receive GMP Certification from Türkiye İlaç ve Tibbi Cihaz Kurumu (TITCK)
Prnewswire· 2025-09-17 04:00
Core Insights - WuXi Biologics has received GMP certification from Türkiye ilaç ve Tıbbi Cihaz Kurumu (TITCK) for three of its manufacturing facilities in Wuxi, marking the first GMP inspection by Turkey's TITCK at the company [1][2] - The certification reflects WuXi Biologics' commitment to maintaining high international quality standards across its global operations [1][4] Manufacturing and Quality Standards - The three facilities, MFG1, MFG2, and DP5, successfully passed a five-day onsite inspection for two monoclonal antibody biologics, validating the company's capabilities in delivering high-quality services [2] - WuXi Biologics has a strong track record, having passed 44 regulatory inspections, including 22 by the FDA and EMA, and holds a 100% pass rate for Pre-License Inspection by the FDA [3] Operational Capacity - The company operates 16 GMP-certified drug substance and drug product facilities globally, reinforcing its reputation for quality and compliance [3] - As of June 30, 2025, WuXi Biologics is supporting 864 integrated client projects, including 24 in commercial manufacturing [6] Leadership and Future Outlook - Dr. Chris Chen, CEO of WuXi Biologics, emphasized the importance of quality in ensuring safety and efficacy in the pharmaceutical industry and expressed commitment to maintaining high standards [4] - The company aims to leverage its first-class quality system and service capabilities to support clients in delivering high-quality biologics to patients worldwide [4] Sustainability Initiatives - WuXi Biologics prioritizes sustainability as a key component of long-term growth, focusing on green technology innovations and responsible practices [7]