Amagasaki Office

Main Site for R&D and Investigational New Drug Manufacturing

At Amagasaki Office, we conduct pharmaceutical product development and manufacturing of investigational new drugs, as well as development of new technology, utilizing our rich experience in global new drug development.

1-3, Kuise Terajima 2-chome, Amagasaki, Hyogo 660-0813 Japan
+81-6-6401-1221

Japan

PMDA

USA

FDA

R&D

Investigational New Drug Development

R&D

We can provide services for any of clients’ needs around pharmaceutical CMC research and development activities, such as API and process development, formulation development, package development, development of analytical methods and specifications and regulatory application support.

API

Formulation

Packaging

Development of analytical
method and specification

Investigational New Drug Development

API

API Manufacturing Building A

Building A is our manufacturing plant for investigational new drugs and intermediates. The plant has 2 multi-purpose manufacturing lines for API and intermediates and ISO class 7 clean room to enable trial manufacturing of a wide range of drugs.

Major Facilities

Manufacturing Area	Reactor with Distiller (200~500L GL·SS) Reactor (300~800L GL) -70˚C Low Temperature Reactor (300L GL) Medium Pressure Reactor (500LGL) Centrifuge (30inch TL) Conical Dryer (400L GL)
Clean Room (ISO Class7)	Reactor Distiller (300L GL) Centrifuge (24inch TL) Dryer (Blender 150L GL)

※GL: Glass Lining　TL: Teflon Lining　SS：Stainless Steel

Building B

API Manufacturing Building B

Building B is for manufacturing of investigational new drugs and intermediates and with 3 manufacturing lines, it has a larger manufacturing capacity than Building A. The manufacturing equipment line-up includes state of the art PAT equipment such as FBRM (Focused Beam Reflectance Measurement) to enable real time process monitoring. The clean room is equipped with Jet Mill to handle clients’ requests from manufacturing to pulverization of investigational new drugs.

Major Facilities

Manufacturing Area	Reactor Distiller (200~1000L GL·SS) Filter (150~330L SS,TL) Centrifuge (24,30inch TL) Conical Dryer (300L 500L GL)
Clean Room (ISO Class7)	Reactor Distiller (1000 GL) Centrifuge (30inch TL) Conical Dryer (500 GL) Pulverizer (Jet Mill SS)

※GL: Glass Lining　TL: Teflon Lining　SS：Stainless Steel

Formulation and Packaging

Formulation and Packaging/Manufacturing Building

Formulation and packaging/manufacturing building is seven stories high. The lower levels are primarily for manufacturing and experimental area for investigational new drug dosage and packaging specifications design, whereas the higher levels are primarily GMP manufacturing area for drug formulation and packaging with focus on investigational new drugs.

Major Facilities

Aseptic Filling Lyophilization	Vial Washer Vial Filler Lyophilizer Rubber stopper washer sterilizer	Vial Dry Heat Sterilizer Vial Accumulator Capper Autoclave
Pulverization	Spiral Jet Mill	Sample Mill
Granulation	10L Type Agitating Granulator Constant Temperature Unit for Agitating Granulator 5L Type Fluidized Bed Granulator Dryer	50L Type Agitating Granulator Cylindrical Granulator 30L Type Fluidized Bed Granulator Dryer
Sizing	Power Mill	Fitz Mill
Mixing	10L Total Capacity V Type Mixer 100L Container Mixer	22L Total Capacity Agitating Granulator
Dry Granulation	Roller Compactor
Capsule Filling	5 Type Capsule Filler Capsule Weight Classifier	Capsule Deduster
Compression	12 Station Compression External Lubrication system for tableting	45 Station Compression
Spray Dry	Spray Dryer (Organic Solvent Capable)
Coating	48 Type Coating	80 Type Coating
Packaging	Semi-automatic PTP Packaging (Sealer) Table-top Vacuum Sealer Multi-purpose Labeler for Multiple Product Types	Semi-automatic PTP Packaging (Trimmer) Table-top Sealer/Labeler

Analysis

In addition to quality testing of investigational new drugs, we can provide various services around quality from investigational new drug API and formulation analysis methods and standards design appropriate for each development stage, stability testing for regulatory application, approval application, and to transfer of analysis technology to commercial manufacturing locations.

Major facilities

Physiochemical Analytical Instruments	Liquid Chromatograph (HPLC,UPLC)/Mass Spectrometer Gas Chromatograph/Mass Spectrometer Ion Chromatograph Nuclear Magnetic Resonance Spectrometer X-ray Powder Diffractometer IR Spectrophotometer Dissolution Tester Disintegration Tester Total Organic Carbon Analyzer Karl Fischer Moisture Meter Potentiometric Titrator	Particle Size Analyzer Tablet Hardness Tester ICP-MS (Inductively Coupled Plasma Mass Spectrometer) ICP-AES (Inductively Couples Plasma Atomic Emission Spectrometer) UV-Visible Spectrophotometer Polarimeter Electrical Conductivity Meter Water Activity Meter Surface Area Analyzer Light Obscuration Fine Particle Counter others
Microbial Testing Instruments	Aseptic Testing Isolator Endotoxin Analyzer Ethylene Oxide Gas Sterilizer	Genetic Analyzer Airborne Bacteria Analyzer others
Surface Area Analysis Instrument	Scanning Electron Microscope
Sample Storage	Low Temperature Thermo-Hygrostat Photostability Testing Chamber	Prefabricated Thermo-Hygrostat others