APIs
Owing to our thorough high-level GMP control we are fully capable of undertaking cGMP operations from the stage of clinical supply.
At Fuji Chemical, we manufacture 1000 tons or more of APIs every year and provide contract manufacturing services to Japanese and foreign pharmaceutical companies; our services mainly include cGMP manufacturing processes from intermediates to APIs. cGMP contract manufacture is undertaken in multipurpose facilities including a pilot building. In addition to 75–9000 L reactors, we have cryogenic/high temperature reactors and autoclaves of maximum 6000 L capacity. We can satisfy various customer needs ranging from pilot -scale trial to commercial production and perform most of reactions.
For the production of APIs, we also have API refining facilities equipped with clean rooms of Class 100,000 or less. Depending upon the volume of production, we can provide 3 trains of crystallizers ranging from 300 L to 6000 L.
List of cGMP Multipurpose Facilities
| Pilot Bldg. | Pilot-scale facility with cryogenic and high temperature reactors | More info |
|---|---|---|
| Organic Bldg.1 | FDA inspected multipurpose facility with reactors of 600–6000 L and clean room | More info |
| Organic Bldg.2 | FDA inspected multipurpose facility with reactors of 100–5000 L | More info |
| Organic Bldg.5 | State of the art facility completed in 2007, with 2000-9000 L reactors | More info |
| Organic Drying Bldg. | FDA inspected facility and used for intermediates and APIs | More info |
| Organic Refining Bldg. | Controlled in Class100,000 or less | More info |
| Warehouse | Temperature controlled warehouse | More info |
Organic Bldg. 1
This is a FDA inspected multipurpose facility with 4000-6000L main reactors. It is tailored for contract manufacture of relatively large scale operations. Since clean rooms are installed, it can be used for refining APIs.
| Capacity | 600-6,000L | number of the reactors | 14 |
|---|---|---|---|
| Centrifuges | 8 | Dryer | 1 |
Organic Bldg. 2
This is a FDA inspected multipurpose plant with 2000-3000L main reactors. It is tailored for medium-scale contract manufacturing activities.
| Capacity | 100-5,000L | number of the reactors | 18 |
|---|---|---|---|
| Centrifuges | 5 | Dryer | 1 |
Organic Bldg. 5
This latest state of the art facility was completed in the end of 2007, with 2000-9000L reactors. It is designed to prevent cross contamination completely.
| Capacity | 2,000-9,000L | number of the reactors | 8 |
|---|---|---|---|
| Centrifuges | 2 | Dryer | 3 |
Organic Drying Bldg.
A FDA inspected drying facility for intermediates and APIs. Each drying equipment is completely partitioned and there is no cross contamination. The production areas of APIs are controlled in Class 100,000 or less.
| Dryer | 5 |
|---|
Pilot Bldg.
The facility is tailored for pilot-scale manufacture. Special reactions including cryogenic and high-temperature reactions are undertaken at this facility. This facility adheres to the cGMP standards, new investigational drugs and small-scale trial drugs can be handled here.
| Capacity | 75-1,500L | number of the reactors | 11 |
|---|---|---|---|
| Centrifuges | 3 | Dryer | 2 |
Organic Refining Bldg.
With clean rooms of Class 100,000 or less, this FDA inspected facility is used for manufacturing APIs.
| Capacity | 300-6,000L | number of the reactors | 5 |
|---|---|---|---|
| Centrifuges | 2 | Dryer | 3 |
Warehouse
Warehousing of raw materials and products is regarded and controlled as a production process. The temperature/humidity are controlled and monitored appropriately.
