Axogen | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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

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pharmacompass-2-2026-02-09

Axogen

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 67 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
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DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INSPECTIONS & REGISTRATIONS

12 FDA

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filter Legal Name Reset all filters

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01 9AxoGen Corporation

02 1Axogen Corp

03 2Axogen Corporation

filter District Decision Reset all filters

12 All

01 11No Action Indicated

02 1Voluntary Action Indicated

filter Inspection End Date Reset all filters

12 All

01 12024-09-06

02 22023-08-04

03 32022-09-22

04 12018-11-20

05 12018-02-08

06 12016-10-28

07 12015-10-13

08 12015-03-13

09 12013-03-14

filter City Reset all filters

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01 3Alachua

02 2Burleson

03 6Dayton

04 1Vandalia

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01 12U.S.A

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01

FDA Audited

USA

Annual COG

Not Confirmed

FDA Audited

USA

Annual COG

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 : 2024-09-06

City : Vandalia

State : Ohio

Country/Area : U.S.A

Zip : 45377

District :

Center :

Project Area : Human Cellular, Tissue, and Gene...

District Decision : No Action Indicated

Inspection End Date : 2024-09-06

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

Annual COG

Not Confirmed

FDA Audited

USA

Annual COG

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 : 2023-08-04

City : Alachua

State : Florida

Country/Area : U.S.A

Zip : 32615

District :

Center :

Project Area : Blood and Blood Products

District Decision : No Action Indicated

Inspection End Date : 2023-08-04

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

Annual COG

Not Confirmed

FDA Audited

USA

Annual COG

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 : 2023-08-04

City : Alachua

State : Florida

Country/Area : U.S.A

Zip : 32615

District :

Center :

Project Area : Human Cellular, Tissue, and Gene...

District Decision : No Action Indicated

Inspection End Date : 2023-08-04

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

Annual COG

Not Confirmed

FDA Audited

USA

Annual COG

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 : 2022-09-22

City : Dayton

State : Ohio

Country/Area : U.S.A

Zip : 45402

District :

Center :

Project Area : Blood and Blood Products

District Decision : No Action Indicated

Inspection End Date : 2022-09-22

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

Annual COG

Not Confirmed

FDA Audited

USA

Annual COG

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 : 2022-09-22

City : Dayton

State : Ohio

Country/Area : U.S.A

Zip : 45402

District :

Center :

Project Area : Human Cellular, Tissue, and Gene...

District Decision : No Action Indicated

Inspection End Date : 2022-09-22

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

Annual COG

Not Confirmed

FDA Audited

USA

Annual COG

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 : 2022-09-22

City : Dayton

State : Ohio

Country/Area : U.S.A

Zip : 45402

District :

Center :

Project Area : Vaccines and Allergenic Products

District Decision : No Action Indicated

Inspection End Date : 2022-09-22

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

Annual COG

Not Confirmed

FDA Audited

USA

Annual COG

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 : 2018-11-20

City : Burleson

State : Texas

Country/Area : U.S.A

Zip : 76028

District :

Center :

Project Area : Human Cellular, Tissue, and Gene...

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-11-20

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

Annual COG

Not Confirmed

FDA Audited

USA

Annual COG

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 : 2018-02-08

City : Alachua

State : Florida

Country/Area : U.S.A

Zip : 32615

District :

Center :

Project Area : Human Cellular, Tissue, and Gene...

District Decision : No Action Indicated

Inspection End Date : 2018-02-08

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

Annual COG

Not Confirmed

FDA Audited

USA

Annual COG

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 : 2016-10-28

City : Dayton

State : Ohio

Country/Area : U.S.A

Zip : 45402

District :

Center :

Project Area : Human Cellular, Tissue, and Gene...

District Decision : No Action Indicated

Inspection End Date : 2016-10-28

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

Annual COG

Not Confirmed

FDA Audited

USA

Annual COG

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 : 2015-10-13

City : Burleson

State : Texas

Country/Area : U.S.A

Zip : 76028

District :

Center :

Project Area : Human Cellular, Tissue, and Gene...

District Decision : No Action Indicated

Inspection End Date : 2015-10-13

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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