Azacitidine (Vidaza) | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Azacitidine (Vidaza)
FDA Orange Book

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

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Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.

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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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Moehs Group, a reference company in the production of pharmaceutical active ingredients.

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pharmacompass-2-m-2025-10-20

Azacitidine (Vidaza)

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 20 USDMF, 3 JDMF, 10 EU WC, 8 KDMF, 17 NDC API, 27 Listed Suppliers, $ API Reference Price

52 API Suppliers
20 USDMF
3 JDMF
10 EU WC
8 KDMF
17 NDC API
27 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

661 Drugs in Development

661 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

200 FDF Dossiers, 20 FDA Orange Book, 53 Europe, 7 Canada, 101 Australia, 3 South Africa, 16 Listed Dossiers

200 FDF Dossiers
20 FDA Orange Book
53 Europe
7 Canada
101 Australia
3 South Africa
16 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 1 Gangwal Healthcare, 2 Pfanstiehl, 3 Kirsch Pharma, 1 Actylis, 1 BASF, 3 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 1 Kerry, 2 Microlex e.U, 1 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

1 Rochem International Inc
13 SPI Pharma
1 Gangwal Healthcare
2 Pfanstiehl
3 Kirsch Pharma
1 Actylis
1 BASF
3 Gangwal Chemicals
1 Ingredion Pharma Solutions
1 Kerry
2 Microlex e.U
1 Pluviaendo
3 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders, 12 Taste Masking, 12 Chewable & Orodispersible Aids, 10 Direct Compression, 7 Disintegrants & Superdisintegrants, 7 Parenteral, 4 Thickeners and Stabilizers, 3 Co-Processed Excipients, 3 Granulation, 2 Coating Systems & Additives, 1 Solubilizers

17 Fillers, Diluents & Binders
12 Taste Masking
12 Chewable & Orodispersible Aids
10 Direct Compression
7 Disintegrants & Superdisintegrants
7 Parenteral
4 Thickeners and Stabilizers
3 Co-Processed Excipients
3 Granulation
2 Coating Systems & Additives
1 Solubilizers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 121 News #PharmaBuzz

1 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
121 News #PharmaBuzz

GLOBAL SALES INFORMATION

15 US Medicaid Prescriptions, 4 Regulatory FDF Prices, 20 Annual Reports

15 US Medicaid Prescriptions
4 Regulatory FDF Prices
20 Annual Reports

MARKET PLACE

9 APIs, 16 FDF Dossiers

9 APIs
16 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents, 4 US Exclusivities, 4 Health Canada Patents

6 US Patents
4 US Exclusivities
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 6 Others

2 USP
6 Others

$ API Ref.Price (USD/KG) : 33,114 Xls

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20 All

01 1DR REDDYS

02 1ACCORD HLTHCARE

03 1ACTAVIS LLC

04 1AMNEAL

05 2BRISTOL

06 1BRISTOL-MYERS

07 1CIPLA

08 1EUGIA PHARMA

09 1EUROHLTH INTL SARL

10 1HETERO LABS LTD VI

11 1JIANGSU HANSOH PHARM

12 1LUPIN LTD

13 1MEITHEAL

14 1MSN LABS PVT LTD

15 1NATCO PHARMA LTD

16 1NORVIUM BIOSCIENCE

17 1RELIANCE LIFE

18 1SHILPA MEDICARE

19 1TEVA PHARMACEUTICALS DEVELOPMENT INC

filter Dosage Reset all filters

20 All

01 17POWDER;INTRAVENOUS, SUBCUTANEOUS

02 1TABLET

03 2TABLET;ORAL

filter Regulatory Info Reset all filters

20 All

01 2DISCN

02 17RX

03 1Blank

filter Brand Name Reset all filters

20 All

01 17AZACITIDINE

02 2ONUREG

03 1VIDAZA

filter RLD Reset all filters

20 All

01 16No

02 3Yes

03 1Blank

List of Suppliers

Product Main Page

01

DR REDDYS

CPhI WW Frankfurt

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

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Digital Content

RLD : No

TE Code : AP

AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2013-09-16

Application Number : 201537

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

Product Web Link

Digital Content

02

ACCORD HLTHCARE

ISPE Annual Meeting

Not Confirmed

ACCORD HLTHCARE

ISPE Annual Meeting

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.

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Digital Content

RLD : No

TE Code : AP

AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2018-07-02

Application Number : 207475

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

ACTAVIS LLC

ISPE Annual Meeting

Not Confirmed

ACTAVIS LLC

ISPE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AP

AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2016-04-29

Application Number : 208216

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

BRISTOL-MYERS

ISPE Annual Meeting

Not Confirmed

BRISTOL-MYERS

ISPE Annual Meeting

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AP

AZACITIDINE

Brand Name : VIDAZA

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2004-05-19

Application Number : 50794

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

CIPLA

CPhI WW Frankfurt

CIPLA

CPhI WW Frankfurt

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.

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Digital Content

RLD : No

TE Code : AP

AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2018-05-04

Application Number : 209540

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

EUROHLTH INTL SARL

ISPE Annual Meeting

Not Confirmed

EUROHLTH INTL SARL

ISPE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AP

AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2020-06-08

Application Number : 209337

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

LUPIN LTD

ISPE Annual Meeting

Not Confirmed

LUPIN LTD

ISPE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code :

AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2019-02-27

Application Number : 210748

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

NATCO PHARMA LTD

ISPE Annual Meeting

Not Confirmed

NATCO PHARMA LTD

ISPE Annual Meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AP

AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2017-06-23

Application Number : 207234

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

NORVIUM BIOSCIENCE

ISPE Annual Meeting

Not Confirmed

NORVIUM BIOSCIENCE

ISPE Annual Meeting

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.

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Digital Content

RLD : No

TE Code :

AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2016-04-28

Application Number : 204949

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

SHILPA MEDICARE

ISPE Annual Meeting

Not Confirmed

SHILPA MEDICARE

ISPE Annual Meeting

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.

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Digital Content

RLD : No

TE Code : AP

AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2016-09-29

Application Number : 207518

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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