API Manufacturing Site for Clinical Trial API to Commercial API

Tokushima Plant has a complete line of equipment and has rich experience in pharmaceutical API manufacturing. Integrated manufacturing from clinical trial API to commercial API can be done at this plant. We can assure sense of security to our clients and enable smooth market introduction.

Tokushima Plant

224-20 Hiraishi Ebisuno, Kawauchi-cho, Tokushima City, Tokushima 771-0132, Japan
TEL +81-88-665-2312

  • Japan
    Japan
    PMDA
    Nov. 2017
  • USA
    USA
    FDA
    Aug. 2016
  • South Korea
    South Korea
    MFDS
    Jan. 2014
  • Russia
    Russia
    Minzsrav
    Mar. 2017

API / Intermediates Manufacturing Facility Building

This is the manufacturing building of API for low molecular weight general pharmaceuticals. This production facility is capable of manufacturing investigational new drug to commercial production. This production facility is an ideal solution for clients contemplating comprehensive contract manufacturing from late development stage to commercial stage manufacturing.
The facility was built with Environmental/Health/Safety (EHS) in mind and by placing emphasis on the safety of workers, including segregation of dangerous materialusage areas and confinement measures against chemicals, the facility has been established to meets global standards. The facility has cleared many overseas agencies' audits.

  • A-2 Building

    A-2 Building

  • Reactor

    Reactor

  • Centrifuge

    Centrifuge

  • Conical Dryer

    Conical Dryer

This is the manufacturing facility of API for low molecular weight general pharmaceuticals. Based on our accumulated manufacturing technologies and rich contract manufacturing experience fostered over many years, we are manufacturing pharmaceutical API in compliance with GMP. We are capable of special manufacturing processes such as ozonation reaction, and with multiple units of counter jet mills, we can flexibly handle pulverizing in accordance with required manufacturing volume.

  • Counter Jet Mill  200AFG

    Counter Jet Mill 200AFG

  • Counter Jet Mill 100AFG

    Counter Jet Mill 100AFG

General Work Area Major Facilities

Reactor 500~6,000L(SUS,GL,MA22)
High Pressure Reactor 6,000, 2,000L(GL)
Low Temperature Reactor 1,500L(GL,-70)˚C
Separator Centrifuge: 39inch(MA22),42inch(TL)
Pressurized Filtration Equipment 3m2(SUS),2m2(TL),1m2(TL)
Dryer Conical: 2,000 (GL), Through Gas Dryer (SUS)
Medium Tank 3,000, 1,500, 500, 300L and others(SUS,GL)
Special Purpose Equipment Ozone Generation Equipment:O3 40g/Nm3-96Nm3/h

Product Area

Reactors 1,500~6,000L(GL,SUS)
Separator Centrifuge:39inch(MA22),42inch(TL)
Dryer Conical:1,000, 3,000L(GL)
Pulverizer Power Mill, Hammer Mill (SUS), Counter Jet Mill 100AFG,200AFG(SUS) (nitrogen/air)

High Pharmacological Activity API Manufacturing Facility Building

This is a multi-purpose plant capable of GMP manufacturing 1-10kg/lot of high pharmacological activity API. We have two manufacturing line that works independently and these systems are rated as Hazard Level 5 (OEL 0.1 to 1μg/m3.) This is an ideal facility for clients looking for a manufacturing facility capable of handling relatively small manufacturing volume of high pharmacological activity material.

  • Glove box for Preparation

    Glove box for Preparation

  • Centrifuge

    Centrifuge

  • Filter Dryer

    Filter Dryer

  • Counter Jet Mill (Isolator specification)

    Counter Jet Mill (Isolator specification)

Dedicated Anti-cancer Drugs General Work Area Major Facilities

Reactor / Distiller 50~100L(GL)
Other Facilities Rotary Evaporator: 30L
Sterilized purified water production equipment

Dedicated Anti-cancer Drugs Product Area Major Facilities

Reactor 50L(GL)
Other Facilities Rotary Evaporator: 30L
Isolator

API General Work Area Major Facilities

Preparation Equipment /High Pressure Reactor 50L(GL)
High Pressure Reactor 300L(GL)
Reactor/Distiller 50~400L(SUS,GL,MA22)
Other facilities Sterilized purified water production equipment

API Product Area Major Facilities

Crystallizer 50, 300L(GL)
Pressurized Filtration Equipment 0.2m2(TL)
Filtration Dryer 0.2m2(MA22)
Separator 25inch(MA22)
Pulverizer Counter Jet Mill 100AFG (SUS)
Other Facilities Isolator

Spray Dryer Facility

As a way of improving solubility of poorly soluble drugs. the Spray Dryer handles the manufacturing of individual particle dispersion. This equipment can also handle organic solvents.

  • Dissolution Equipment

    Dissolution Equipment

  • Coulter Dryer

    Coulter Dryer

Coulter Dryer CD-5 Type manufactured by Japan Chemical Engineering & Machinery

Solvent Evaporation Volume 40.0kg/H (Acetone 95%, Ethanol 5%)
Original Solution Processing Capacity 44.0kg/h(max)
Spray Nozzle High Pressure Revolving Spray Type
Hot Air intake Temperature 120~140 ± 3˚C
Exhaust Air Outlet Temperature Dependent on outcome (about 85˚C expected)
Material in Contact with Drug, Finish SUS, Buffed #400
Air Heating Method Indirect Steam Heating
Fine Particle Collection Method Bug Filter (Filter cloth: Heat resistant Polyester felt)