Langhua Pharmaceutical Earns FDA Approval, Strengthening Global CDMO Services

Zhejiang Langhua Pharmaceutical Co., Ltd., a subsidiary of Viva Biotech Holdings, has once again demonstrated its commitment to excellence by successfully passing its fourth FDA on-site inspection. The inspection covered six critical cGMP systems, including quality, materials, production, and laboratory control, reinforcing the company’s strong regulatory compliance. The receipt of the Establishment Inspection Report (EIR) from the U.S. FDA underscores Langhua’s robust quality management system, further strengthening its ability to deliver customized pharmaceutical solutions worldwide.

With over a decade of dedicated growth, Langhua Pharmaceutical has positioned itself as a leading CDMO (Contract Development and Manufacturing Organization) for small molecule drugs. The company provides end-to-end solutions from APIs to finished dosage forms, supporting projects from pre-clinical stages to commercial supply. With three strategic R&D centers, a team of 700+ researchers, and certifications from global regulatory authorities, Langhua has played a pivotal role in launching over 20 new drugs across oncology, HIV, diabetes, and cardiovascular fields. By maintaining stringent quality control and innovation-driven development, Langhua Pharmaceutical continues to be a trusted partner for global pharma enterprises.