Viva Biotech's Wholly-Owned Subsidiary Langhua Pharmaceutical Successfully Passes U.S. FDA On-Site Inspection

SHANGHAI, March 28, 2025 /PRNewswire/ -- Zhejiang Langhua Pharmaceutical Co., Ltd. ("Langhua Pharmaceutical"), a wholly-owned subsidiary of Viva Biotech Holdings ("Viva Biotech"), underwent a cGMP (Current Good Manufacturing Practices) on-site inspection by the U.S. Food and Drug Administration ("FDA"), and received the EIR (Establishment Inspection Report) from the FDA. This is the fourth time that Langhua Pharmaceutical has undergone and passed the on-site inspection by the FDA, indicating the effective operation of the Company's quality control system. It also enables the Company to offer globally customized research, development, and production services to pharmaceutical enterprises worldwide.

In the second half of 2024, Langhua Pharmaceutical has undergone the on-site inspection by the FDA which covered six major systems, namely, quality system, materials, production, packaging and labeling system, equipment and facilities, and laboratory control.

After more than a decade of dedicated growth, Langhua Pharmaceutical has become a one-stop CDMO solution for small molecule drug. The company offers comprehensive solutions spanning from Active Pharmaceutical Ingredients (APIs) to Finished Dosage Form (FDF), from pre-clinical to commercial supply, covering the entire lifecycle with efficient, flexible, and high-quality CDMO services. Langhua's innovative R&D network spans three strategic centers situated in Shanghai, Ningbo, and Taizhou, collectively offering over 13,000 square meters of laboratory space and a team of over 700 researchers. The company has established comprehensive quality management systems, EHS (Environment, Health, and Safety) protocols, and intellectual property protection mechanisms. To date, Langhua Pharmaceutical has passed audits and certifications from leading authorities including China's National Medical Products Administration (NMPA), the FDA, the European Directorate for the Quality of Medicines (EDQM), Pharmaceutical and Medical Devices Agency (PMDA), Brazilian Health Regulatory Agency (ANVISA), and the World Health Organization (WHO). Additionally, it has also passed the PSCI audit. Langhua Pharmaceutical has contributed to more than 20 new drugs launches in the past years, with a product line that spans oncology, HIV, diabetes, and cardiovascular fields, showcasing a strong track record of successful deliveries.

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, providing a solid foundation for our further expansion into the international market. In the future, we will continue to promote the construction of CDMO production capacity and deepen the synergy between CRO and CDMO businesses to empower the development and production of new drugs for more global partners."

Mr. Weidong Zhang, Senior Vice President of Viva Biotech, Executive Vice President and Manufactory General Manager of Langhua Pharmaceutical, expressed: "We are delighted that Langhua Pharmaceutical has once again gained FDA recognition. We always uphold the principle that GMP compliance is the 'bottom line' that Langhua must adhere to, implementing comprehensive quality control at every stage from raw materials to finished products. In the future, Langhua Pharmaceutical will sustain to adhere to a meticulous quality management philosophy, continuously enhancing its innovative R&D capabilities to provide higher-quality and more reliable CDMO services to global clients."

About Viva Biotech

Established in 2008, Viva Biotech (01873.HK) provides one-stop services ranging from early-stage Structure-Based Drug R&D to commercial manufacturing to global biopharmaceutical innovators. We offer leading early-stage to late-phase drug discovery expertise by integrating our dedicated team of experts, cutting-edge technology platforms, and state-of-the-art equipment in X-ray crystallization, Cryo-EM, DEL, ASMS, SPR, HDX, AIDD/CADD, and much more. Our business covers all aspects of therapeutic strategies and drug modalities, including small molecules and biologics across the pharma and biotech spectrum. The experienced chemistry team, led by senior medicinal chemists and drug discovery biologists, provides services for drug design, medicinal chemistry (hit to lead and lead optimization), custom synthesis, chemical analysis and purification, kilogram scale-up, peptide synthesis and corresponding bioassays. With our subsidiary, Langhua Pharma, we offer our worldwide pharmaceutical and biotech partners a one-stop integrated CMC (Chemical, Manufacturing, and Control) service from preclinical to commercial manufacturing. Additionally, Viva embedded an equity for service (EFS) model to high potential startups to address unmet medical needs.

About Langhua

Zhejiang Langhua Pharmaceutical Co., Ltd, is a comprehensive pharmaceutical company engaged in research and development, production, marketing, and sourcing of pharmaceutical products. As the subsidiary of Viva Biotech Holdings, the leading enterprise in the field of innovative drug discovery, we offer our worldwide partners a One-Stop CDMO solution in new drugs' entire life cycle for small molecule Active Pharmaceutical Ingredients (APIs) and Finished Dosage Form (FDF), from pre-clinical to commercial supply.

SOURCE Viva Biotech