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Quality

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Meeting global quality standard

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7

successful US FDA inspections

2013, 2014, 2016, 2018 and 2019

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2

successful EU EMA inspections

2019

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30+

successful China NMPA inspections

2015-2020

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2

successful Japan EMA inspection

2019

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3

successful SwissMedic inspections

2018, 2019 & 2020

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200+

client audits every year

Worldwide approvals

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105+

country approvals for branded drugs

2013, 2014, 2016, 2018 and 2019

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40+

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

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

2015-2020