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

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Impax Laboratories
FDA

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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pharmacompass-1-m-2026-04-20

PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

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Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.

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Impax Laboratories

VIRTUAL BOOTH, Contact Details

VIRTUAL BOOTH
CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 116 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
116 News #PharmaBuzz

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

FINISHED DOSAGE FORMULATIONS

306 FDF Dossiers, 306 FDA Orange Book

306 FDF Dossiers
306 FDA Orange Book

INSPECTIONS & REGISTRATIONS

19 FDA, 2 GDUFA

19 FDA
2 GDUFA

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FILTER :

filter Legal Name Reset all filters

19 All

01 2Global Pharmaceuticals, Div of Impax Laboratories Inc.

02 2Impax Laboratories, Inc.

03 15Impax Laboratories, LLC.

filter District Decision Reset all filters

19 All

01 8No Action Indicated

02 3Official Action Indicated

03 8Voluntary Action Indicated

filter Inspection End Date Reset all filters

19 All

01 12019-01-18

02 32017-08-23

03 22016-05-04

04 12015-05-08

05 12014-07-31

06 22013-02-28

07 12012-03-28

08 12011-11-04

09 22011-01-21

10 12010-04-22

11 22009-08-07

12 12009-03-26

13 12008-12-01

filter City Reset all filters

19 All

01 17Hayward

02 2Philadelphia

filter Country/Area Reset all filters

19 All

01 19U.S.A

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : 2019-01-18

Impax Laboratories

City : Hayward

State : California

Country/Area : U.S.A

Zip : 94544

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2019-01-18

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : U.S.A

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

03

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : California

Country/Area : U.S.A

Zip : 94544

District :

Center :

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

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : California

Country/Area : U.S.A

Zip : 94544

District :

Center :

Project Area : Postmarket Surv. and Epidemiolog...

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-08-23

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : 2016-05-04

Impax Laboratories

City : Hayward

State : California

Country/Area : U.S.A

Zip : 94544

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-05-04

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : 2016-05-04

Impax Laboratories

City : Hayward

State : California

Country/Area : U.S.A

Zip : 94544

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-05-04

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : California

Country/Area : U.S.A

Zip : 94544

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-05-08

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : California

Country/Area : U.S.A

Zip : 94544

District :

Center :

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

09

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : U.S.A

Zip : 94544

District : SAN

Center : CVM

Project Area : Monitoring of Marketed Animal Dr...

District Decision : Official Action Indicated

Inspection End Date : 2013-02-28

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : California

Country/Area : U.S.A

Zip : 94544

District :

Center :

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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