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Details of Aenova Group's U.S. FDA Inspections. Original Data: FDA Inspection Database

Aenova Group
Temmler Pharma GmbH & Co. KG
FDA

Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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xyz-pharma-m-2024-10-07

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Evonik

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Gensenta is a trusted CDMO partner with robust history, commitment to quality, innovative mindset and commitment to sustainability.

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xyz-pharma-m-2024-10-07

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Aenova Group

VISIT THE VIRTUAL BOOTH, Contact Details

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CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 43 NEWS #PharmaBuzz

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

ACTIVE PHARMA INGREDIENTS

5 All APIs, 4 USDMF, 1 Listed APIs

5 All APIs
4 USDMF
1 Listed APIs

SERVICES

Analytical, Drug Product Manufacturing, API & Drug Product Development, Packaging

Analytical
Drug Product Manufacturing
API & Drug Product Development
- 2 Formulation Development
Packaging
- 9 Contract Services

INSPECTIONS & REGISTRATIONS

26 FDA, 4 EDQM, 5 GDUFA

26 FDA
4 EDQM
5 GDUFA

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filter Legal Name Reset all filters

26 All

01 2Aenova France

02 2Haupt Pharma Amareg GmbH

03 3Haupt Pharma Latina Srl

04 2Haupt Pharma Muenster GmbH

05 4Haupt Pharma Wolfratshausen GmbH

06 1Haupt Pharma Wulfing GmbH

07 3Swiss Caps AG

08 6Swiss Caps USA, Inc.

09 3Temmler Pharma GmbH & Co. KG

filter District Decision Reset all filters

26 All

01 10No Action Indicated

02 16Voluntary Action Indicated

filter Inspection End Date Reset all filters

26 All

01 12017-03-17

02 12014-11-04

03 12014-10-31

04 12014-06-05

05 22014-03-28

06 12014-03-21

07 22014-03-18

08 12013-11-22

09 12013-05-31

10 12012-12-12

11 12012-11-23

12 12012-06-22

13 22012-05-11

14 12012-03-30

15 12011-05-18

16 12010-11-25

17 42010-11-17

18 12010-05-27

19 12010-04-02

20 12009-10-13

filter City Reset all filters

26 All

01 1Gronau (Leine)

02 3Kirchberg Sg

03 3Latina

04 3Marburg

05 6Miami

06 2Munster

07 2Ratisbon

08 2St Quentin Fallavier Cedex

09 4Wolfratshausen

filter Country/Area Reset all filters

26 All

01 3CH

02 12DE

03 2FR

04 3IT

05 6US

FDA
EDQM
GDUFA

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

AllPack Indonesia 2024

Not Confirmed

FDA Audited

USA

AllPack Indonesia 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 : 2014-03-28

Aenova Group

City : Miami

State : FL

Country/Area : US

Zip : 33186-6013

District : FLA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-03-28

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

AllPack Indonesia 2024

Not Confirmed

FDA Audited

USA

AllPack Indonesia 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 : 2014-03-28

Aenova Group

City : Miami

State : FL

Country/Area : US

Zip : 33186-6013

District : FLA

Center : CFSAN

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

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-03-28

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

AllPack Indonesia 2024

Not Confirmed

FDA Audited

USA

AllPack Indonesia 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 : 2009-10-13

Aenova Group

City : Latina

State :

Country/Area : IT

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-10-13

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

AllPack Indonesia 2024

Not Confirmed

FDA Audited

USA

AllPack Indonesia 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 : 2010-05-27

Temmler Pharma GmbH & Co. KG

City : Marburg

State :

Country/Area : DE

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-05-27

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

AllPack Indonesia 2024

Not Confirmed

FDA Audited

USA

AllPack Indonesia 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 : 2012-06-22

Temmler Pharma GmbH & Co. KG

City : Marburg

State :

Country/Area : DE

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-06-22

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

AllPack Indonesia 2024

Not Confirmed

FDA Audited

USA

AllPack Indonesia 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 : 2010-11-17

Aenova Group

City : Miami

State : FL

Country/Area : US

Zip : 33186-6013

District : FLA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-11-17

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

AllPack Indonesia 2024

Not Confirmed

FDA Audited

USA

AllPack Indonesia 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 : 2014-06-05

Temmler Pharma GmbH & Co. KG

City : Marburg

State :

Country/Area : DE

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance