Shanghai Hengrui Pharmaceutical | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Shanghai Hengrui Pharmaceutical
FDA

FAMAR CDMO- From early development to commercial manufacturing.

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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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

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Together we can improve the quality of life

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Shanghai Hengrui Pharmaceutical

VIRTUAL BOOTH, Contact Details

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EVENTS

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DIGITAL CONTENT

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DEVELOPMENTS

63 Drugs in Development

63 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2 FDF Dossiers, 2 FDA Orange Book

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2 FDA Orange Book

INSPECTIONS & REGISTRATIONS

11 FDA, 1 EDQM, 1 GDUFA

11 FDA
1 EDQM
1 GDUFA

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filter Legal Name Reset all filters

11 All

01 2Jiangsu Hengrui Pharmaceuticals Co., Ltd.

02 5Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)

03 4Shanghai Hengrui Pharmaceutical Co., Ltd.

filter District Decision Reset all filters

11 All

01 4No Action Indicated

02 1Official Action Indicated

03 6Voluntary Action Indicated

filter Inspection End Date Reset all filters

11 All

01 12025-04-04

02 12024-10-25

03 12024-01-19

04 12024-01-16

05 12018-07-20

06 12018-05-14

07 12016-11-02

08 12015-03-27

09 12014-05-13

10 12013-09-06

11 12012-07-26

filter City Reset all filters

11 All

01 7Lianyungang

02 4Shanghai

filter Country/Area Reset all filters

11 All

01 11China

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01

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2025-04-04

Shanghai Hengrui Pharmaceutical

City : Lianyungang

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2025-04-04

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02

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

FDA Audited

USA

34th NZW-Hamburg

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 : 2024-10-25

Shanghai Hengrui Pharmaceutical

City : Shanghai

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-10-25

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03

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

FDA Audited

USA

34th NZW-Hamburg

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 : 2024-01-19

Shanghai Hengrui Pharmaceutical

City : Lianyungang

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2024-01-19

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04

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

FDA Audited

USA

34th NZW-Hamburg

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 : 2024-01-16

Shanghai Hengrui Pharmaceutical

City : Lianyungang

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2024-01-16

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05

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

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District Decision : No Action Indicated

Inspection End Date : 2018-07-20

Shanghai Hengrui Pharmaceutical

City : Shanghai

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2018-07-20

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06

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

FDA Audited

USA

34th NZW-Hamburg

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 : 2018-05-14

Shanghai Hengrui Pharmaceutical

City : Lianyungang

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-05-14

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07

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

FDA Audited

USA

34th NZW-Hamburg

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 : 2016-11-02

Shanghai Hengrui Pharmaceutical

City : Lianyungang

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-11-02

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08

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

FDA Audited

USA

34th NZW-Hamburg

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 : 2015-03-27

Shanghai Hengrui Pharmaceutical

City : Shanghai

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-03-27

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09

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

FDA Audited

USA

34th NZW-Hamburg

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 : 2014-05-13

Shanghai Hengrui Pharmaceutical

City : Lianyungang

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-05-13

Product
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10

FDA Audited

USA

34th NZW-Hamburg

Not Confirmed

FDA Audited

USA

34th NZW-Hamburg

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 : 2013-09-06

Shanghai Hengrui Pharmaceutical

City : Shanghai

State :

Country/Area : China

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-09-06

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