Langhua Pharmaceutical Passes Fourth FDA cGMP Inspection

• Langhua Pharmaceutical has successfully passed its fourth U.S. FDA cGMP inspection and received the Establishment Inspection Report (EIR).

• The inspection covered six major systems, reaffirming the company’s quality management and strengthening its global contract manufacturing services.

Zhejiang Langhua Pharmaceutical Co., Ltd. (“Langhua Pharmaceutical”), a wholly owned subsidiary of Viva Biotech Holdings, has passed its fourth on-site Current Good Manufacturing Practices (cGMP) inspection by the U.S. Food and Drug Administration (FDA). Following the inspection, the company received an Establishment Inspection Report (EIR), confirming compliance with FDA requirements.

The FDA’s inspection, conducted in the second half of 2024, assessed six major systems: quality, materials, production, packaging and labeling, equipment and facilities, and laboratory control. This successful outcome reinforces Langhua Pharmaceutical’s ability to provide global pharmaceutical enterprises with tailored research, development, and production services.

Langhua Pharmaceutical operates as a one-stop CDMO, offering small molecule drug solutions from Active Pharmaceutical Ingredients (APIs) to Finished Dosage Forms (FDFs). With a presence in Shanghai, Ningbo, and Taizhou, the company boasts over 13,000 square meters of laboratory space and a research team exceeding 700 members. It has secured regulatory approvals from multiple authorities, including the FDA, China’s NMPA, EDQM, PMDA, ANVISA, and WHO, while also passing the PSCI audit.

Dr. Cheney Mao, Chairman and CEO of Viva Biotech Holdings, stated: “We are glad to see Langhua Pharmaceutical passing the FDA cGMP on-site inspection again, demonstrating that our quality management system and production environment facilities consistently meet international standards.”

Mr. Weidong Zhang, Senior Vice President of Viva Biotech and Executive Vice President & Manufactory General Manager of Langhua Pharmaceutical, expressed his satisfaction with Langhua’s renewed FDA recognition. He emphasised that adhering to GMP compliance is a fundamental principle for the company, ensuring strict quality control at every stage, from raw materials to final products. Looking ahead, Langhua Pharmaceutical remains committed to maintaining rigorous quality management, strengthening its innovative R&D capabilities, and delivering even higher-quality and more reliable CDMO services to clients worldwide.