Luye Pharma | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Luye Pharma
FDA

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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pharmacompass-1-m-2026-01-12

LEBSA- Your strategic API source for niche molecules.

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

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pharmacompass-2-m-2025-11-03

Luye Pharma

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, 44 News #PharmaBuzz

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

DEVELOPMENTS

124 Drugs in Development

124 Drugs in Development

FINISHED DOSAGE FORMULATIONS

15 FDF Dossiers, 6 FDA Orange Book, 8 Europe, 1 Listed Dossiers

15 FDF Dossiers
6 FDA Orange Book
8 Europe
1 Listed Dossiers

INSPECTIONS & REGISTRATIONS

4 FDA

4 FDA

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filter Legal Name Reset all filters

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01 3Luye Pharma AG

02 1SHANDONG LUYE PHARMACEUTICAL CO., LTD

filter District Decision Reset all filters

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01 3No Action Indicated

02 1Voluntary Action Indicated

filter Inspection End Date Reset all filters

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01 12024-05-14

02 12019-07-09

03 12015-06-19

04 12013-08-01

filter City Reset all filters

4 All

01 3Miesbach

02 1Yantai

filter Country/Area Reset all filters

4 All

01 1China

02 3Germany

Supplier Virtual Booth

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01

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2024-05-14

Luye Pharma

City : Yantai

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2024-05-14

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2019-07-09

Luye Pharma

City : Miesbach

State :

Country/Area : Germany

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-07-09

Product
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Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2015-06-19

Luye Pharma

City : Miesbach

State :

Country/Area : Germany

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-06-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2013-08-01

Luye Pharma

City : Miesbach

State :

Country/Area : Germany

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-08-01

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.