Lonza Capsugel | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Lonza Capsugel
FDA

Evonik

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Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

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xyz-pharma-m-2024-10-07

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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Lonza Capsugel

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Corporate Presentation, Expert Interview: Matthew Moorcroft, Lonza, GMP Certificate 2020

Corporate Presentation
Expert Interview: Matthew Moorcroft, Lonza
GMP Certificate 2020

VIDEO(s)

Capsugel Ultra™ III Capsule Filling Machine, Capsugel® at CPhI 2018

Capsugel Ultra™ III Capsule Filling Machine
Capsugel® at CPhI 2018

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 129 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
129 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

138 All APIs, 76 USDMF, 11 CEP/COS, 58 JDMF, 11 KDMF, 34 NDC API, 3 VMF

138 All APIs
76 USDMF
11 CEP/COS
58 JDMF
11 KDMF
34 NDC API
3 VMF

DEVELOPMENTS

38 Drugs in Development

38 Drugs in Development

SERVICES

Analytical, Drug Product Manufacturing, API & Drug Product Development, Clinical Trials

Analytical
- 1 Stability Studies
- 1 Analytical Method Development
Drug Product Manufacturing
API & Drug Product Development
- 1 Preformulation & Material Science
- 2 Formulation Development
Clinical Trials
- 3 Clinical Development / Phase IIb-IV

EXCIPIENTS

33 All Excipients, 32 USDMF, 3 JDMF, 1 Listed Excipients, 6 Listed Products

33 All Excipients
32 USDMF
3 JDMF
1 Listed Excipients
6 Listed Products

EXCIPIENTS BY INGREDIENTS

Hydroxypropyl Methyl Cellulose, Gelatin, Unspecified, HPMC AS

Hydroxypropyl Methyl Cellulose
Gelatin, Unspecified
HPMC AS

EXCIPIENTS BY APPLICATIONS

Empty Capsules, Vegetarian Capsules, API Stability Enhancers, Controlled & Modified Release, Taste Masking

Empty Capsules
Vegetarian Capsules
API Stability Enhancers
Controlled & Modified Release
Taste Masking

INSPECTIONS & REGISTRATIONS

43 FDA, 22 EDQM, 5 GDUFA

43 FDA
22 EDQM
5 GDUFA

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FILTER :

filter Legal Name Reset all filters

43 All

01 1Capsugel Manufacturing

02 3Capsugel Ploermel, S.A.S.

03 15Lonza Biologics Inc

04 1Lonza Biologics Tuas Pte Ltd

05 1Lonza Biologics, Inc.

06 1Lonza Braine SA

07 15Lonza Group Ltd

08 6Lonza Inc & Lonza America Inc.

filter District Decision Reset all filters

43 All

01 18No Action Indicated

02 1Official Action Indicated

03 24Voluntary Action Indicated

filter Inspection End Date Reset all filters

43 All

01 12019-04-23

02 12018-04-20

03 12017-09-21

04 12017-03-16

05 12017-02-24

06 12015-11-26

07 12015-03-10

08 12015-02-10

09 12015-01-30

10 12014-08-29

11 22014-08-20

12 12014-05-30

13 12014-05-23

14 22014-04-02

15 12013-11-07

16 12013-09-30

17 12013-08-23

18 12013-08-13

19 12013-05-14

20 12013-05-02

21 12013-04-12

22 22012-09-24

23 12012-09-18

24 12012-08-03

25 12012-06-14

26 12011-12-02

27 12011-08-23

28 12011-05-06

29 12011-04-20

30 12010-12-04

31 12010-11-18

32 12010-10-07

33 12010-06-30

34 12010-06-24

35 12010-04-21

36 12010-02-17

37 12009-12-17

38 12009-10-09

39 12009-09-03

40 12008-10-10

filter City Reset all filters

43 All

01 1Braine -l\'alleud

02 1Braine-L'Alleud

03 1Braine-l\'alleud

04 1Cohasset

05 3Guangzhou

06 3Hopkinton

07 3Kourim

08 1Morristown

09 1O Porrino (Casco Urbano)

10 1Pan de Azucar

11 3Ploermel

12 5Portsmouth

13 3Singapore

14 1Slough

15 6Visp

16 5Walkersville

17 2Williamsport

18 1Wokingham

19 1Yanzhoushi

filter Country/Area Reset all filters

43 All

01 3BE

02 6CH

03 1CL

04 4CN

05 3CZ

06 1ES

07 3FR

08 3SG

09 2UK

10 17US

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

SupplySide West 2024

Not Confirmed

FDA Audited

USA

SupplySide West 2024

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 : 2014-04-02

Lonza Group

City : Visp

State :

Country/Area : CH

Zip :

District : ORA

Center : CFSAN

Project Area : Food Composition, Standards, Lab...

District Decision : No Action Indicated

Inspection End Date : 2014-04-02

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

SupplySide West 2024

Not Confirmed

FDA Audited

USA

SupplySide West 2024

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 : 2015-03-10

Lonza Group

City : Singapore

State :

Country/Area : SG

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-03-10

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

SupplySide West 2024

Not Confirmed

FDA Audited

USA

SupplySide West 2024

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 : 2014-05-30

Lonza Group

City : Braine-l\\\'alleud

State :

Country/Area : BE

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-05-30

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

SupplySide West 2024

Not Confirmed

FDA Audited

USA

SupplySide West 2024

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 : 2014-08-29

Lonza Group

City : Visp

State :

Country/Area : CH

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-08-29

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

SupplySide West 2024

Not Confirmed

FDA Audited

USA

SupplySide West 2024

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 : 2014-04-02

Lonza Group

City : Visp

State :

Country/Area : CH

Zip :

District : ORA

Center : CFSAN

Project Area : Foodborne Biological Hazards

District Decision : No Action Indicated

Inspection End Date : 2014-04-02

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

SupplySide West 2024

Not Confirmed

FDA Audited

USA

SupplySide West 2024

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 : 2013-11-07

Lonza Group

City : Guangzhou

State :

Country/Area : CN

Zip :

District : ORA

Center : CFSAN

Project Area : Foodborne Biological Hazards

District Decision : No Action Indicated

Inspection End Date : 2013-11-07

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

SupplySide West 2024

Not Confirmed

FDA Audited

USA

SupplySide West 2024

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 : 2019-04-23

Lonza Capsugel

City : Morristown

State : NJ

Country/Area : US

Zip : 07960-6674

District : NWJ

Center : CFSAN

Project Area : Foodborne Biological Hazards

District Decision : No Action Indicated

Inspection End Date : 2019-04-23

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

SupplySide West 2024

Not Confirmed

FDA Audited

USA

SupplySide West 2024

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 : 2010-02-17

Lonza Capsugel

City : Ploermel

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-02-17

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

SupplySide West 2024

Not Confirmed

FDA Audited

USA

SupplySide West 2024

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 : 2015-01-30

Lonza Capsugel

City : Ploermel

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-01-30

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

SupplySide West 2024

Not Confirmed

FDA Audited

USA

SupplySide West 2024

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 : 2018-04-20

Lonza Capsugel

City : Ploermel

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-04-20

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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