Exciting News | China’s Largest Semaglutide API Production Facility Passes U.S. FDA Inspection

From August 26 to August 30, 2024, JYMed’s peptide production facility, Hubei JX Bio-Pharmaceutical Co., Ltd., successfully passed an on-site inspection conducted by the U.S. Food and Drug Administration (FDA). The inspection covered key areas such as the quality system, production system, equipment and facility system, laboratory controls, and materials management system.

This marks the first FDA inspection successfully completed by the Hubei JX peptide production facility. According to the inspection report, the facility’s quality and production systems fully meet FDA standards.

JYMed extends its sincere gratitude to its strategic partner, Rochem, for their continuous support during past and present FDA inspections.

This achievement signifies that Hubei JX’s peptide production facility adheres to FDA requirements for quality and production systems, qualifying it for entry into the U.S. market.

About JYMed

Founded in 2009, Shenzhen JYMed Technology Co., Ltd. is a biotechnology company specializing in the independent research, development, production, and sales of peptide products, alongside custom peptide R&D and manufacturing services. The company offers over 20 peptide APIs, with five products, including Semaglutide and Tirzepatide, having successfully completed U.S. FDA DMF filings.

The Hubei JX facility features 10 production lines for peptide APIs (including pilot-scale lines) that comply with cGMP standards of the U.S., EU, and China. The facility operates a comprehensive pharmaceutical quality management system and an EHS (Environmental, Health, and Safety) management system. It has passed NMPA official GMP inspections and EHS audits conducted by leading global clients.

Core Services

1.Domestic and international peptide API registration
2.Veterinary and cosmetic peptides
3.Custom peptide synthesis, CRO, CMO, and OEM services
4.PDC (Peptide Drug Conjugates), including peptide-radionuclide, peptide-small molecule, peptide-protein, and peptide-RNA conjugates

Contact Information

Address: 8th & 9th Floors, Building 1, Shenzhen Biomedical Innovation Industrial Park, Jin Hui Road 14, Kengzi Street, Pingshan District, Shenzhen, China

For International API Inquiries:
+86-755-26612112 | +86-15013529272

For Domestic Cosmetic Peptide Raw Materials:
+86-755-26612112 | +86-15013529272

For Domestic API Registration and CDMO Services:
+86-15818682250

Website: www.jymedtech.com