Niagara Pharmaceuticals | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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NIAGARA PHARMACEUTICALS
FDA

Trusted Global CDMO Partner Delivering End-to-End Pharma Manufacturing & Development Solutions.

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Evonik Health Care is the innovation hub for leading life science companies

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Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

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Axplora is your partner of choice for complex APIs.

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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pharmacompass-2-2026-02-09

NIAGARA PHARMACEUTICALS

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EVENTS

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DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow

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FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers, 1 FDA Orange Book

1 FDF Dossiers
1 FDA Orange Book

INSPECTIONS & REGISTRATIONS

6 FDA

6 FDA

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filter Legal Name Reset all filters

6 All

01 6Niagara Pharmaceuticals Inc

filter District Decision Reset all filters

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01 2No Action Indicated

02 1Official Action Indicated

03 3Voluntary Action Indicated

filter Inspection End Date Reset all filters

6 All

01 12022-04-25

02 12020-02-07

03 12017-09-18

04 12016-05-16

05 12014-05-14

06 12010-09-08

filter City Reset all filters

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01 6Dundas

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01 6Canada

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01

FDA Audited

USA

BePharma

Not Confirmed

FDA Audited

USA

BePharma

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District Decision : Voluntary Action Indicated

Inspection End Date : 2022-04-25

NIAGARA PHARMACEUTICALS

City : Dundas

State :

Country/Area : Canada

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-04-25

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02

FDA Audited

USA

BePharma

Not Confirmed

FDA Audited

USA

BePharma

Not Confirmed

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District Decision : Official Action Indicated

Inspection End Date : 2020-02-07

NIAGARA PHARMACEUTICALS

City : Dundas

State :

Country/Area : Canada

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Center :

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2020-02-07

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03

FDA Audited

USA

BePharma

Not Confirmed

FDA Audited

USA

BePharma

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District Decision : No Action Indicated

Inspection End Date : 2017-09-18

NIAGARA PHARMACEUTICALS

City : Dundas

State :

Country/Area : Canada

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District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-09-18

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04

FDA Audited

USA

BePharma

Not Confirmed

FDA Audited

USA

BePharma

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District Decision : Voluntary Action Indicated

Inspection End Date : 2016-05-16

NIAGARA PHARMACEUTICALS

City : Dundas

State :

Country/Area : Canada

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-05-16

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05

FDA Audited

USA

BePharma

Not Confirmed

FDA Audited

USA

BePharma

Not Confirmed

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District Decision : No Action Indicated

Inspection End Date : 2014-05-14

NIAGARA PHARMACEUTICALS

City : Dundas

State :

Country/Area : Canada

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-05-14

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06

FDA Audited

USA

BePharma

Not Confirmed

FDA Audited

USA

BePharma

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2010-09-08

NIAGARA PHARMACEUTICALS

City : Dundas

State :

Country/Area : Canada

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-09-08

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