Japan represents one of the world's most sophisticated and strictly regulated pharmaceutical markets. As the third-largest pharmaceutical market globally, Japan’s demand for high-quality Active Pharmaceutical Ingredients (APIs) is driven by an aging population, a government mandate to increase generic drug penetration to over 80%, and a robust regenerative medicine sector.
We provide full support for Master File (MF) registration and Foreign Manufacturer Accreditation (FMA) in accordance with Japan's PMDA requirements.
Adherence to the Japanese Pharmacopoeia (JP) standards, ensuring impurity profiles meet the most stringent local toxicological safety limits.
Long-term partnership focus with transparent communication, critical for successful collaboration with Japanese 'Shoji' (trading firms).
In the current global economic climate, diversifying the supply chain is paramount. Shanghai Aeterna Biotech serves as a critical bridge, offering China's manufacturing scale combined with an "International Quality First" philosophy. We specialize in overcoming the technical barriers that often prevent international manufacturers from entering the Japanese market, such as residual solvent testing and elemental impurity analysis (ICH Q3D).
The future of API manufacturing for the Japan market lies in "Green Chemistry" and "Digital Quality Systems." Our roadmap includes:
Shanghai Aeterna Biotech Co., Ltd. is a leading, reliable, and professional manufacturer specializing in fine chemicals, plant extracts, enzyme preparations, and nutritional ingredients. Our expertise spans research, development, production, and global sales. With decades of experience, we have built a solid reputation for delivering high-quality products and innovative solutions to a wide range of industries including the Japanese healthcare and functional food sectors.
Our facilities are equipped with state-of-the-art production and testing equipment, allowing us to meet the highest industry standards. Through years of serving European, American, and Asian markets, our QA/QC team has gained extensive experience in impurity analysis, precise control of flavor and fragrance formulations, and rigorous quality management. Our commitment to safety and reliability ensures that every product meets the expectations of both clients and end consumers in Japan.
Physical and Chemical Tests
Moisture Detection
Assay Detection
PH Meter
Electrical Conductivity Meter
Mould Incubator
High Temperature Sterilizing Pot
Analytical Balance
Drying Oven
Ash Detection Machine (JP Compliance)
HPLC Detection Machine for Impurity Profiling
UV Detection Machine
UV Spectrophotometer
Electric Thermostatic Drying Oven
Waters High Performance Liquid Chromatograph
Box Type Electric Furnace
Atomic Absorption Spectrophotometer
Ultraviolet Camera Obscura
Aeterna Biotech
