Research & Development
Langhua Pharmaceutical passes US FDA's on-site inspection
31 March 2025 -

Viva Biotech Holdings announced on Friday that its wholly-owned subsidiary, Zhejiang Langhua Pharmaceutical Co., Ltd., successfully completed a cGMP on-site inspection by the US Food and Drug Administration and received the Establishment Inspection Report.

This marks the fourth successful FDA inspection, reflecting the effectiveness of its quality control system. The latest inspection covered six major systems, including quality, materials, production, packaging and labeling, equipment and facilities, and laboratory control.

Langhua Pharmaceutical provides end-to-end CDMO solutions for small molecule drugs, covering Active Pharmaceutical Ingredients and Finished Dosage Forms from pre-clinical to commercial supply. Its R&D network includes three centers in Shanghai, Ningbo and Taizhou, with over 13,000 square meters of laboratory space and more than 700 researchers. The company maintains rigorous quality management, EHS protocols and intellectual property safeguards while holding certifications from major regulatory bodies, including China's National Medical Products Administration, the FDA and the World Health Organization. With contributions to over 20 new drug launches, Langhua Pharmaceutical supports therapies in oncology, HIV, diabetes and cardiovascular treatments.

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