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Quality & Compliance
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Meeting global quality standard
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9

9 successful US FDA inspections 

2013-2021

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4

4 successful EU EMA inspections

2019-2022

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40+

30+ successful China NMPA inspections

2015-2022

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4

4 successful Japan EMA inspections

2019-2022

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4 successful South Korean MFDS inspections

2022

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3

3 successful SwissMedic inspections 

2018-2020

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300+

300+ client audits every year

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Gateway to China

1st CDMO to support a new drug launch in China via ONE integrated CMC platform including both drug substance and drug product

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105

105 country approvals for branded drugs

210+ CMC submission packages written to support global IND and NDA filings since 2019


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