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01 1Aeropharm Gmbh

02 6Eon Labs Inc

03 9LEK d.d.

04 8Lek d.d.

05 18Sandoz GmbH

06 1Sandoz Inc

07 10Sandoz Incorporated

08 6Sandoz Industrial Products, S.A.

09 8Sandoz Private Limited

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PharmaCompass

01

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Lek Pharmaceuticals

City : Prevalje

State :

Country/Area : Slovenia

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2024-10-02

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02

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Lek Pharmaceuticals

City : Ljubljana

State :

Country/Area : Slovenia

Zip :

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2024-07-26

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03

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Sandoz B2B

City : Navi Mumbai

State :

Country/Area : India

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-07-02

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04

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Sandoz B2B

City : Princeton

State : New Jersey

Country/Area : U.S.A

Zip : 8540

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2024-05-10

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05

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Lek Pharmaceuticals

City : Ljubljana

State :

Country/Area : Slovenia

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2023-12-11

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06

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Sandoz B2B

City : Kundl

State :

Country/Area : Austria

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-11-17

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07

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Lek Pharmaceuticals

City : Lendava/Lendva

State :

Country/Area : Slovenia

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-11-24

blank

08

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Sandoz B2B

City : Palafolls

State :

Country/Area : Spain

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-07-21

blank

09

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Sandoz B2B

City : Langkampfen

State :

Country/Area : Austria

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-07-11

blank

10

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Sandoz B2B

City : Rudolstadt

State :

Country/Area : Germany

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-06-06

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