cGMP Production

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Manufacturing from lab to commercial scales.

Equipment
All equipments have been validated to meet regulatory requirement including:

 

CCSB Layout

All our process equipments are manufactured in Taiwan, U.S, Japan or Europe.
 
GMP Audit List
 
List of GMP inspections of the site within the last 6 years 

Name of regulatory authorities
Inspection date
Name of inspected products
TFDA
2013(May 28-29)
Rapamycin
Olopatadine HCl
TFDA
2013(Oct 16-18)
Everolimus
Caspofungin Acetate
Korea FDA
2013(Aug 21-23)
Tacrolimus
Japan PMDA
2013(Jun 18-20)
Tacrolimus
US FDA
2014(May 16, 19-20)
System based
EU-Inspection
Germany Authority
2015(March 24-26)
Pravastatin   Sodium
Tacrolimus
TFDA
2015(3/30-4/1)
Ethyl Icosapentate
Fluconazole
US FDA
2017(March 27-29)
Ethyl Icosapentate
PMDA
2017(July 11-13)
Rapamycin
TFDA
2018(Feb 22-23)
Methocarbamol
Pravastatin Sodium
Metaxalone
Alprazolam
Rapamycin
Mycophenolate Mofetil
Olopatadine HCl
Everolimus
Everolimus B20
Caspofungin Acetate
Fluconazole
US FDA
2018(Nov 05-09)
System based
EU-Inspection
France
2019(June 19-21)
Methocarbamol

Facilities / Capacity
The area of Shulin plant is 32,000 square meters with approximately 330 employees. The facilities have been audited and approved by both local and foreign authorities and major customers.
Our facilities consist of 12 areas for fermentation, purification and chemical synthesis for production ranging from kilograms to multiple tons. Fermentation capacity ranges from 350L to 30,000L. Purification and synthesis ranging from 10L to 15,000L. Reactors are made from either  stainless or glass-lined. There are 7 areas for chemical synthesis, 3 areas for downstream purification and  2 area for fermentation production. Each area has its separate building with segregated clean room to perform filtration, drying, milling, sieving, packaging.


The plant operation areas includes 

Production Area 01 30L-500L 1Kg-10Kg
Production Area 02 100L-8,000L 10Kg-550Kg
Production Area 03 500L-7,000L 190Kg-1,600Kg
Production Area 05 30L-7,000L 1Kg-16Kg
Production Area 06 100L-8,000L 2Kg-30Kg
Production Area 07 350L-30,000 3Kg-30Kg
Production Area 09 30L-1,000L 0.1Kg-10Kg
Production Area 11 10L-1,000L 0.2Kg-14Kg
Production Area 12 2000L-15,000L 190Kg-1,200Kg
Production Area 13 50L-2,000L 0.1Kg-3Kg
Production Area 15 30,000L 10Kg-15Kg
Production Area 16 200L-15,000L 15Kg-30Kg

 

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