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