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Langhua Pharmaceutical's FDA Achievement

On March 28, 2025, Zhejiang Langhua Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Viva Biotech Holdings, reached a significant milestone by successfully passing the on-site inspection from the U.S. Food and Drug Administration (FDA) for Current Good Manufacturing Practices (cGMP). This being the fourth successful cGMP inspection reflects the robust quality management system established by Langhua Pharmaceutical and enhances its position as a trusted partner for pharmaceutical enterprises worldwide.

The recent inspection, which took place in the latter half of 2024, rigorously examined six critical systems: quality assurance, material handling, production processes, packaging and labeling, equipment and facilities maintenance, along with laboratory controls. The positive outcome demonstrates Langhua's unwavering commitment to excellence in pharmaceuticals, making it well-equipped to provide comprehensive research, development, and manufacturing services on a global scale.

Over the past decade, Langhua Pharmaceutical has evolved into a one-stop Contract Development and Manufacturing Organization (CDMO) specializing in small molecule drugs. The company excels in its ability to deliver a full range of services, which encompass everything from Active Pharmaceutical Ingredients (APIs) to Finished Dosage Forms (FDF), in both pre-clinical and commercial phases. Langhua operates through a formidable research and development network featuring three strategic centers located in Shanghai, Ningbo, and Taizhou, boasting more than 13,000 square meters of laboratory facilities and a dedicated team of over 700 researchers.

Langhua has been proactive in ensuring that its operations align with the stringent requirements set forth by various health authorities across the globe. It has successfully navigated audits and certifications from key regulatory bodies, including the National Medical Products Administration in China, the FDA, the European Directorate for the Quality of Medicines, the Pharmaceutical and Medical Devices Agency in Japan, the Brazilian Health Regulatory Agency, and the World Health Organization. Additionally, the company has met the criteria of the Pharmaceutical Supply Chain Initiative (PSCI) audit, underscoring its commitment to best practices in quality and safety.

The achievements of Langhua Pharmaceutical in the past few years have resulted in the launch of more than 20 new drugs targeting essential health domains such as oncology, HIV, diabetes, and cardiovascular issues. This remarkable record reinforces its reputation as a reliable CDMO capable of handling the entire lifecycle of drug development with efficiency and high-quality service.

Dr. Cheney Mao, the Chairman and CEO of Viva Biotech Holdings, expressed his satisfaction with Langhua’s FDA cGMP inspection success, remarking that it validates the company's effective quality management framework and production standards, which are crucial for scaling international market expansion. He emphasized the future course involves enhancing CDMO production capabilities while deepening synergy between CRO (Contract Research Organization) and CDMO operations to facilitate drug development for global partners.

Mr. Weidong Zhang, Senior Vice President of Viva Biotech and Executive Vice President at Langhua Pharmaceutical, echoed these sentiments, articulating the continuous pursuit of compliance with GMP standards as the bedrock of Langhua's operations. He assured that the company will remain steadfast in its quality management philosophy while further advancing its innovative R&D capabilities aimed at providing top-tier CDMO services to clients worldwide.

With a commendable track record and a future-oriented vision, Langhua Pharmaceutical is poised to remain a leader in the field of pharmaceutical manufacturing and research, significantly impacting the global healthcare industry.