Pi Health Sciences | CEP/COS | Details of Certificates of Suitability | Pharmacompass.com

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PI Health Sciences
CEP/COS

Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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Smithfield BioScience transforms bioproducts into trusted, life-saving therapies through safe, reliable U.S.-based manufacturing.

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Evonik

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

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Temad- We think of world-class quality.

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PI Health Sciences

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EVENTS

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Product List 2025

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

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ACTIVE PHARMA INGREDIENTS

36 All APIs, 13 USDMF, 4 CEP/COS, 4 KDMF, 20 NDC API, 19 Listed APIs

36 All APIs
13 USDMF
4 CEP/COS
4 KDMF
20 NDC API
19 Listed APIs

INSPECTIONS & REGISTRATIONS

12 FDA, 3 GDUFA

12 FDA
3 GDUFA

Xls

Filters

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FILTER :

filter Substance Reset all filters

4 All

01 1Cytarabine

02 1Cytarabine, Process 2

03 1Hydroxycarbamide

04 1Mianserin hydrochloride

filter Certificate Holder Reset all filters

4 All

01 4ARCHIMICA S.P.A Lodi IT

filter Country Reset all filters

4 All

01 4Italy

filter Status Reset all filters

4 All

01 4Valid

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Cytarabine

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Certificate Holder

ARCHIMICA S.P.A Lodi IT

Status

Valid

Certificate Number

R1-CEP 2000-048 - Rev 04

Type

Chemical

Issue Date

2020-10-16

End Date

Substance Number

760

01

Cytarabine

CEP/COS

ACS Fall 2025

Not Confirmed

Cytarabine

ACS Fall 2025

Not Confirmed

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Certificate Numbers : R1-CEP 2000-048 - Rev 04

Status : Valid

Issue Date : 2020-10-16

Type : Chemical

Substance Number : 760

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Archimica

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Cytarabine, Process 2

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Certificate Holder

ARCHIMICA S.P.A Lodi IT

Status

Valid

Certificate Number

CEP 2023-289 - Rev 00

Type

Chemical

Issue Date

2024-02-06

End Date

Substance Number

760

02

Cytarabine, Process 2

CEP/COS

ACS Fall 2025

Not Confirmed

Cytarabine, Process 2

ACS Fall 2025

Not Confirmed

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Certificate Numbers : CEP 2023-289 - Rev 00

Status : Valid

Issue Date : 2024-02-06

Type : Chemical

Substance Number : 760

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Archimica

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Hydroxycarbamide

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Certificate Holder

ARCHIMICA S.P.A Lodi IT

Status

Valid

Certificate Number

R1-CEP 2003-120 - Rev 03

Type

Chemical

Issue Date

2020-09-18

End Date

Substance Number

1616

03

Hydroxycarbamide

CEP/COS

ACS Fall 2025

Not Confirmed

Hydroxycarbamide

ACS Fall 2025

Not Confirmed

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Certificate Numbers : R1-CEP 2003-120 - Rev 03

Status : Valid

Issue Date : 2020-09-18

Type : Chemical

Substance Number : 1616

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Archimica

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Digital Content

Mianserin hydrochloride

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Certificate Holder

ARCHIMICA S.P.A Lodi IT

Status

Valid

Certificate Number

CEP 2022-250 - Rev 00

Type

Chemical

Issue Date

2024-11-28

End Date

Substance Number

846

04

Mianserin hydrochloride

CEP/COS

ACS Fall 2025

Not Confirmed

Mianserin hydrochloride

ACS Fall 2025

Not Confirmed

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Certificate Numbers : CEP 2022-250 - Rev 00

Status : Valid

Issue Date : 2024-11-28

Type : Chemical

Substance Number : 846

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