Athena Pharmaceutiques Oral Dispersible Tablets

Athena Pharmaceutiques Oral Dispersible Tablets

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Details of Catalent Pharma Solutions's U.S. FDA Inspections. Original Data: FDA Inspection Database

CATALENT PHARMA SOLUTIONS

About, Contact Details

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Corporate Presentation, GMP Certificate 2021

VIDEO(s)

Corporate Video, Flexible Filling Line, Metered Dose Inhaler (MDI) Services, Nasal Spray Manufacturing, Secondary Packaging Capability, Softgel Technology, Syringe Filling Line, Vial Filling Line, Zydis® ODT

DIGITAL CONTENT

404 News

404 News

APIs // Active Pharmaceutical Ingredients

82 APIs, 81 USDMF, 1 JDMF, 44 NDC API

DEVELOPMENTS

51 Drug(s) in Development

51 Drug(s) in Development

DOSSIERs // Finished Dosage Formulations

3 Dossiers, 3 FDA Orange Book

SERVICES

All Services, Analytical, API Manufacturing, Drug Product Manufacturing, Sales, Marketing, Registration, Clinical Trials, API & Drug Product Development, Packaging

All Services
Analytical
- 1 Analytical Testing Services
- 1 Analytical Method Development
API Manufacturing
- 1 Micronization
Drug Product Manufacturing
Sales, Marketing, Registration
- 1 Regulatory Affairs / Pharmacovigilance
Clinical Trials
- 2 Packaging & Logistics
API & Drug Product Development
- 2 Preformulation & Material Science
- 8 Formulation Development
Packaging
- 3 Clinical Services
- 4 Contract Services

EXCIPIENTS

8 Regulatory Filings, 8 USDMF

INSPECTIONS & REGISTRATIONS

130 FDA, 69 EDQM, 17 GDUFA

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District Decision

No Action Indicated

Inspection End Date

2009-11-16

City

San Diego

State

CA

Country/Area

US

Zip

92126-6314

District

LOS

Center

CDER

Project Area

Drug Quality Assurance

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District Decision

No Action Indicated

Inspection End Date

2017-11-06

City

Kansas City

State

MO

Country/Area

US

Zip

64137-1418

District

KAN

Center

CVM

Project Area

Monitoring of Marketed An...

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District Decision

No Action Indicated

Inspection End Date

2017-11-06

City

Kansas City

State

MO

Country/Area

US

Zip

64137-1418

District

KAN

Center

CDER

Project Area

Drug Quality Assurance

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US

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District Decision

No Action Indicated

Inspection End Date

2015-06-29

City

Kansas City

State

MO

Country/Area

US

Zip

64137-1418

District

KAN

Center

CVM

Project Area

Monitoring of Marketed An...

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District Decision

No Action Indicated

Inspection End Date

2015-06-29

City

Kansas City

State

MO

Country/Area

US

Zip

64137-1418

District

KAN

Center

CDER

Project Area

Drug Quality Assurance

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District Decision

Voluntary Action Indicated

Inspection End Date

2014-11-10

City

Kansas City

State

MO

Country/Area

US

Zip

64137-1418

District

KAN

Center

CDER

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Drug Quality Assurance

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District Decision

No Action Indicated

Inspection End Date

2014-03-05

City

Kansas City

State

MO

Country/Area

US

Zip

64137-1418

District

KAN

Center

CDER

Project Area

Drug Quality Assurance

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US

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District Decision

No Action Indicated

Inspection End Date

2013-01-14

City

Kansas City

State

MO

Country/Area

US

Zip

64137-1418

District

KAN

Center

CDER

Project Area

Drug Quality Assurance

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US

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District Decision

No Action Indicated

Inspection End Date

2012-06-08

City

Kansas City

State

MO

Country/Area

US

Zip

64137-1418

District

KAN

Center

CDER

Project Area

Drug Quality Assurance

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District Decision

No Action Indicated

Inspection End Date

2010-03-24

City

Kansas City

State

MO

Country/Area

US

Zip

64137-1418

District

KAN

Center

CVM

Project Area

Monitoring of Marketed An...

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US

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District Decision

Voluntary Action Indicated

Inspection End Date

2010-03-24

City

Kansas City

State

MO

Country/Area

US

Zip

64137-1418

District

KAN

Center

CDER

Project Area

Drug Quality Assurance

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US

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District Decision

Voluntary Action Indicated

Inspection End Date

2019-08-28

City

Saint Petersburg

State

FL

Country/Area

US

Zip

33716-1016

District

FLA

Center

CDRH

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Compliance: Devices

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District Decision

Voluntary Action Indicated

Inspection End Date

2019-02-22

City

Saint Petersburg

State

FL

Country/Area

US

Zip

33716-1016

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FLA

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CDER

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District Decision

Voluntary Action Indicated

Inspection End Date

2018-06-14

City

Saint Petersburg

State

FL

Country/Area

US

Zip

33716-1016

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FLA

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CDER

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District Decision

Voluntary Action Indicated

Inspection End Date

2016-03-25

City

Saint Petersburg

State

FL

Country/Area

US

Zip

33716-1016

District

FLA

Center

CDER

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Postmarket Surv. and Epid...

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District Decision

Voluntary Action Indicated

Inspection End Date

2016-03-25

City

Saint Petersburg

State

FL

Country/Area

US

Zip

33716-1016

District

FLA

Center

CDER

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Drug Quality Assurance

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District Decision

Voluntary Action Indicated

Inspection End Date

2013-12-30

City

Saint Petersburg

State

FL

Country/Area

US

Zip

33716-1016

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FLA

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CDER

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District Decision

No Action Indicated

Inspection End Date

2012-06-21

City

Saint Petersburg

State

FL

Country/Area

US

Zip

33716-1016

District

FLA

Center

CFSAN

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Food Composition, Standar...

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District Decision

Voluntary Action Indicated

Inspection End Date

2011-03-29

City

Saint Petersburg

State

FL

Country/Area

US

Zip

33716-1016

District

FLA

Center

CDER

Project Area

Drug Quality Assurance

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District Decision

Voluntary Action Indicated

Inspection End Date

2009-03-06

City

Saint Petersburg

State

FL

Country/Area

US

Zip

33716-1016

District

FLA

Center

CDER

Project Area

Drug Quality Assurance

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District Decision

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Inspection End Date

2019-10-18

City

Bloomington

State

IN

Country/Area

US

Zip

47403-4828

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CDER

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District Decision

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2018-08-03

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Bloomington

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IN

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Zip

47403-4828

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CBER

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District Decision

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2018-01-19

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Bloomington

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IN

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Zip

47403-4828

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District Decision

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Inspection End Date

2017-05-19

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Bloomington

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IN

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US

Zip

47403-4828

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2017-05-19

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Bloomington

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IN

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47403-4828

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District Decision

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2016-08-24

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Bloomington

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IN

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47403-4828

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2014-11-07

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Bloomington

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IN

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Zip

47403-4828

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District Decision

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2013-10-25

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Bloomington

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47403-4828

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District Decision

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2013-06-17

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Bloomington

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IN

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Zip

47403-4828

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District Decision

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2011-12-15

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Bloomington

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IN

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Zip

47403-4828