API Manufacturing Site for Clinical Trial API to Commercial API

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.

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  A-2 Building

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  Reactor

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  Centrifuge

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  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.

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  Counter Jet Mill 200AFG

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  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.

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  Glove box for Preparation

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  Centrifuge

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  Filter Dryer

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  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