Ony Biotech | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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ONY Biotech
FDA

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

ONY Biotech

VIRTUAL BOOTH, Contact Details

VIRTUAL BOOTH
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow

ACTIVE PHARMA INGREDIENTS

2 All APIs, 1 USDMF, 1 CEP/COS

2 All APIs
1 USDMF
1 CEP/COS

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers, 1 FDA Orange Book

1 FDF Dossiers
1 FDA Orange Book

INSPECTIONS & REGISTRATIONS

8 FDA

8 FDA

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filter Legal Name Reset all filters

8 All

01 8ONY Biotech, Inc.

filter District Decision Reset all filters

8 All

01 5No Action Indicated

02 1Official Action Indicated

03 2Voluntary Action Indicated

filter Inspection End Date Reset all filters

8 All

01 12024-09-26

02 12017-03-02

03 12015-10-09

04 22013-04-25

05 12011-10-06

06 12010-11-09

07 12009-12-03

filter City Reset all filters

8 All

01 8Amherst

filter Country/Area Reset all filters

8 All

01 8U.S.A

Supplier Virtual Booth

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01

FDA Audited

USA

euroPLX 90 Lisbon

Not Confirmed

FDA Audited

USA

euroPLX 90 Lisbon

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 : 2024-09-26

ONY Biotech

City : Amherst

State : New York

Country/Area : U.S.A

Zip : 14228

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2024-09-26

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

euroPLX 90 Lisbon

Not Confirmed

FDA Audited

USA

euroPLX 90 Lisbon

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 : 2017-03-02

ONY Biotech

City : Amherst

State : New York

Country/Area : U.S.A

Zip : 14228

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2017-03-02

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

euroPLX 90 Lisbon

Not Confirmed

FDA Audited

USA

euroPLX 90 Lisbon

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 : 2015-10-09

ONY Biotech

City : Amherst

State : New York

Country/Area : U.S.A

Zip : 14228

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-10-09

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

euroPLX 90 Lisbon

Not Confirmed

FDA Audited

USA

euroPLX 90 Lisbon

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 : 2013-04-25

ONY Biotech

City : Amherst

State : New York

Country/Area : U.S.A

Zip : 14228

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-04-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

euroPLX 90 Lisbon

Not Confirmed

FDA Audited

USA

euroPLX 90 Lisbon

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 : 2013-04-25

ONY Biotech

City : Amherst

State : New York

Country/Area : U.S.A

Zip : 14228

District :

Center :

Project Area : Postmarket Surv. and Epidemiolog...

District Decision : No Action Indicated

Inspection End Date : 2013-04-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

euroPLX 90 Lisbon

Not Confirmed

FDA Audited

USA

euroPLX 90 Lisbon

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 : 2011-10-06

ONY Biotech

City : Amherst

State : New York

Country/Area : U.S.A

Zip : 14228

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-10-06

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

euroPLX 90 Lisbon

Not Confirmed

FDA Audited

USA

euroPLX 90 Lisbon

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 : 2010-11-09

ONY Biotech

City : Amherst

State : New York

Country/Area : U.S.A

Zip : 14228

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2010-11-09

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

euroPLX 90 Lisbon

Not Confirmed

FDA Audited

USA

euroPLX 90 Lisbon

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 : 2009-12-03

ONY Biotech

City : Amherst

State : New York

Country/Area : U.S.A

Zip : 14228

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-12-03

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

Contact Ony Biotech and get a quotation

Ony Biotech is a supplier offers 1 products (APIs, Excipients or Intermediates).

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