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Quality

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Meeting global quality standard

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9

successful US FDA inspections

2013-2021

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4

successful EU EMA inspections

2019-2022

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30+

successful China NMPA inspections

2015-2022

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4

successful Japan EMA inspection

2019-2022

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4

successful South Korean MFDS inspections

2022

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3

successful SwissMedic inspections

2018-2020

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300+

client audits every year

Worldwide approvals

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105+

country approvals for branded drugs

2013-2022

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210+

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

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1st

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

2015-2022