API Solutions
Facilities & Capabilities
Meeting Expanded Needs with Additional Resources
Asymchem’s eight state-of-the-art manufacturing sites, while located throughout Northeast China, are built from the ground up to US and European standards. Together these facilities offer powerful production capacity — from preclinical kg scale production of toxicological batches to scaled-up clinical and commercial manufacturing on tonne-scale.
Each facility is staffed with experienced technical teams that can seamlessly ensure that your production process can quickly be transferred from laboratory scale or pilot scale up to full commercial production.
Multiple Locations Offer Manufacturing Flexible Solutions
- Built to US / European standards
- Single Quality Management system across all manufacturing sites
- 2,462.7 m³ Total
- Reactors ranging in size from 5L to 20,000L
- Pilot scale up to commercial production
| Purpose | Site | Capacities | Vessel sizes | Working Parameters | ||
|---|---|---|---|---|---|---|
| cGMP | cGMP-like | Working Temperature | Working Pressure | |||
| HP, API, high-pressure chemistry | TJ1 (Tianjin, China) | 11.55m³ | -- | 5L~1,000L | -20°C ~ 110°C | -0.1 ~ 70 atm |
| All aspects of chemical manufacturing & development | TJ2 (Tianjin, China) | 125.60m³ | -- | 5L~8,000L | -90°C ~ 120°C | -1 ~ 2 atm |
| cGMP manufacturing, formulation (tablets, capsules, granules, pellets) | TJ3 (Tianjin, China) | 106.0m³ | -- | 500L~8,000L | -110°C ~ 200°C | -0.1 ~ 70 atm |
| RSM & Carbapenems | FX1 (Fuxin, China) | 349.7m³ | 268.3m³ | 80L~12,500L | -90°C ~ 130°C | -1 ~ 2 atm |
| Non-cGMP, Back Integration | FX2 (Fuxin, China) | -- | 375.1m³ | 500L~12,500L | -90°C ~ 130°C | -1 ~ 2 atm |
| cGMP manufacturing, RSMs, high-pressure chemistry | DH1 (Dunhua, China) | 748.4m³ | 214.5m³ | 200L~20,000L | -90°C ~ 200°C | -0.1 ~ 70 atm |
| Carbapenem manufacturing | DH2 (Dunhua, China) | 263.5m³ | -- | 3,000L~20,000L | -90°C ~ 110°C | -0.1 ~ 70 atm |
| Total | 1,604.8m³ | 857.9m³ | ||||
| Total (GMP & NonGMP) | 2,462.7m³ | |||||
| Purpose | Capacity & Equipment | ||
|---|---|---|---|
| API Manufacture | 169.33m³ | 5-100L | GL Reactor |
| 200-8,000L | GL/ Hastelloy/ SS/TiS Reactor | ||
| cGMP Pilot/Commercial Manufacture | 810.83m³ | 5-20,000L | GL/SS/ Autoclave/ TiS Reactor |
| 613.2m³ | 500-20,000L | GL/SS/ Hastelloy/(Penem Intermediates) | |
| Non-GMP Pilot/Commercial Manufacture | 861.9m³ | 200-20,000L | GL/SS/Autoclave |
| High Potency | Seven HP area | 5-80L | GL Reactor |
| 200-1,000L | GL Reactor | ||
| Continuous Production | Pipe Reactors for Diazotization, Ozonization, Cryogenic Reaction, High-temperature and Other Regular Reactions by Asymchem Design low-temperature reaction(≤-20 degree), high-temperature reaction（≥150 degree), Diazomethane reaction, Ozonation reaction, Oxidation reaction with peroxides, Nitration reaction, Photochemical reaction, Electrochemical Reaction, catalytic hydrogenation reaction, Grignard reagent prepara-tion and appliction, Curtius rearrangement, Continuous reaction with high energy reagents (TMSN3, NaN3, etc.), Continuous reaction with gas（Acetylene, Ethylene, Ammonia, oxygen | ||
| Biotransformation | 4×50L, 4×500L, 2×5000L, Reactor | ||
| Function | Equipment/Capability | OEL Rating | |
|---|---|---|---|
| Asymchem Laboratories (Tianjin) Co., Ltd TJ1 | HiPo R&D Labs | 2 labs：6 fume hoods+2 Isolators | ≤0.05μg/m³ |
| HiPo Kilo Labs (Class D) | 3 labs: 3 Isolators,2~20L glass reactor (-80-150°C) 1 lab: Isolator,Flexible isolator, 2~80L glass reactor (-80-150°C) Freeze-drying Lab: 2m2 Lyophilizer Pre-HPLC DAC150, Nanofiltration, 2.5-10m2 TFF Module 3: modules: 200-1000L glass-lined reactor / stainless steel reactor (-20-120°C) Solid material charging Isolator,Jet milling, wet milling |
≤0.05μg/m³ | |
| Analytical | 1 QCLab: 1 Isolator | ≤0.05μg/m³ |