Impax Laboratories | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Impax Laboratories
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Impax Laboratories

VISIT THE VIRTUAL BOOTH, Contact Details

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DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 116 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
116 NEWS #PharmaBuzz

FINISHED DOSAGE FORMULATIONS

306 FDF Dossiers, 306 FDA Orange Book

306 FDF Dossiers
306 FDA Orange Book

INSPECTIONS & REGISTRATIONS

20 FDA, 2 GDUFA

20 FDA
2 GDUFA

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filter Legal Name Reset all filters

20 All

01 1Impax Laboratories (Taiwan) Inc.

02 19Impax Laboratories, Inc.

filter District Decision Reset all filters

20 All

01 5No Action Indicated

02 6Official Action Indicated

03 9Voluntary Action Indicated

filter Inspection End Date Reset all filters

20 All

01 32017-08-23

02 12017-02-17

03 12015-05-08

04 12014-08-12

05 12014-07-31

06 12014-02-21

07 12013-03-26

08 22013-02-28

09 12012-06-11

10 12012-03-28

11 12011-02-25

12 12011-01-21

13 12010-04-22

14 12010-01-20

15 12009-09-14

16 12009-08-07

17 12008-11-14

filter City Reset all filters

20 All

01 11Hayward

02 1Miaoli County

03 8Middlesex

filter Country/Area Reset all filters

20 All

01 1TW

02 19US

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

The Generic Rx Session

Not Confirmed

FDA Audited

USA

The Generic Rx Session

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2017-08-23

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

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-08-23

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

Product
Web Link

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#PipelineProspector

Data Compilation
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03

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2017-08-23

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

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2017-02-17

Impax Laboratories

City : Miaoli County

State :

Country/Area : TW

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-02-17

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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05

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-05-08

Impax Laboratories

City : Hayward

State : CA

Country/Area : US

Zip : 94544

District : SAN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-05-08

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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06

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2014-08-12

Impax Laboratories

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 : 2014-08-12

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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07

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-07-31

Impax Laboratories

City : Hayward

State : CA

Country/Area : US

Zip : 94544

District : SAN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-07-31

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2014-02-21

Impax Laboratories

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 : 2014-02-21

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-03-26

Impax Laboratories

City : Middlesex

State : NJ

Country/Area : US

Zip : 08846-2554

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-03-26

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

PharmScience R&D

Not Confirmed

FDA Audited

USA

PharmScience R&D

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Official Action Indicated

Inspection End Date : 2013-02-28

Impax Laboratories

City : Hayward

State : CA

Country/Area : US

Zip : 94544

District : SAN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2013-02-28

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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