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01 1Amedra Pharmaceuticals LLC

02 10Amneal Pharmaceuticals

03 2Amneal Pharmaceuticals Company India Private Limited

04 2Amneal Pharmaceuticals India Pvt. Ltd.

05 3Amneal Pharmaceuticals LLC

06 1Amneal Pharmaceuticals Pvt Ltd.

07 2Amneal Pharmaceuticals of New York, LLC

08 8Amneal Pharmaceuticals, LLC

09 5Amneal Pharmaceuticals, Llc

10 1CorePharma, LLC

11 1Impax Laboratories (Taiwan) Inc.

12 19Impax Laboratories, Inc.

13 2Raks Pharma Pvt. Ltd.

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PharmaCompass

01

FDA Audited

USA
The Generic Rx Session
Not Confirmed
arrow

FDA Audited

USA
arrow
The Generic Rx Session
Not Confirmed

Amneal Pharmaceuticals

City : Paterson

State : NJ

Country/Area : US

Zip : 07504-1005

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-10-25

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02

FDA Audited

USA
The Generic Rx Session
Not Confirmed
arrow

FDA Audited

USA
arrow
The Generic Rx Session
Not Confirmed

CorePharma, LLC

City : Middlesex

State : NJ

Country/Area : US

Zip : 08846-2554

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-10-13

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03

FDA Audited

USA
The Generic Rx Session
Not Confirmed
arrow

FDA Audited

USA
arrow
The Generic Rx Session
Not Confirmed

Amneal Pharmaceuticals

City : Ahmedabad

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-09-22

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04

FDA Audited

USA
The Generic Rx Session
Not Confirmed
arrow

FDA Audited

USA
arrow
The Generic Rx Session
Not Confirmed

Impax Laboratories

City : Hayward

State : CA

Country/Area : US

Zip : 94544-7905

District : SAN

Center : CVM

Project Area : Monitoring of Marketed Animal Dr...

District Decision : No Action Indicated

Inspection End Date : 2017-08-23

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05

FDA Audited

USA
The Generic Rx Session
Not Confirmed
arrow

FDA Audited

USA
arrow
The Generic Rx Session
Not Confirmed

Impax Laboratories

City : Hayward

State : CA

Country/Area : US

Zip : 94544-7905

District : SAN

Center : CDER

Project Area : Postmarket Surv. and Epidemiolog...

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-08-23

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06

FDA Audited

USA
The Generic Rx Session
Not Confirmed
arrow

FDA Audited

USA
arrow
The Generic Rx Session
Not Confirmed

Impax Laboratories

City : Hayward

State : CA

Country/Area : US

Zip : 94544-7905

District : SAN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-08-23

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07

FDA Audited

USA
The Generic Rx Session
Not Confirmed
arrow

FDA Audited

USA
arrow
The Generic Rx Session
Not Confirmed

Amneal Pharmaceuticals

City : Branchburg

State : NJ

Country/Area : US

Zip : 08876-3587

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-07-27

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08

FDA Audited

USA
The Generic Rx Session
Not Confirmed
arrow

FDA Audited

USA
arrow
The Generic Rx Session
Not Confirmed

Amneal Pharmaceuticals

City : Brookhaven

State : NY

Country/Area : US

Zip : 11719-9509

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-24

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09

FDA Audited

USA
The Generic Rx Session
Not Confirmed
arrow

FDA Audited

USA
arrow
The Generic Rx Session
Not Confirmed

Amneal Pharmaceuticals

City : Ahmedabad

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-04-12

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10

FDA Audited

USA
The Generic Rx Session
Not Confirmed
arrow

FDA Audited

USA
arrow
The Generic Rx Session
Not Confirmed

Amneal Pharmaceuticals

City : Hauppauge

State : NY

Country/Area : US

Zip : 11788-3605

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-04-11

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