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

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Azacitidine
FDA Orange Book

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Inke S.A: APIs manufacturing plant.

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xyz-pharma-2025-04-21

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

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With Fermion, start the journey of your innovative API.

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jdmfs-not-supported-m-2025-04-28

Azacitidine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 21 USDMF, 3 JDMF, 6 EU WC, 8 KDMF, 17 NDC API, 27 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

194 Drugs in Development

194 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

161 FDF Dossiers, 18 FDA Orange Book, 15 Europe, 8 Canada, 101 Australia, 3 South Africa, 16 Listed Dossiers

161 FDF Dossiers
18 FDA Orange Book
15 Europe
8 Canada
101 Australia
3 South Africa
16 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 1 Faran Shimi Pharmaceutical, 1 Gangwal Healthcare, 2 Pfanstiehl, 1 Actylis, 1 BASF, 3 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 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 Faran Shimi Pharmaceutical
1 Gangwal Healthcare
2 Pfanstiehl
1 Actylis
1 BASF
3 Gangwal Chemicals
1 Ingredion Pharma Solutions
2 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, 11 Chewable & Orodispersible Aids, 10 Direct Compression, 7 Disintegrants & Superdisintegrants, 5 Parenteral, 5 Co-Processed Excipients, 3 Thickeners and Stabilizers, 3 Granulation, 2 Coating Systems & Additives, 1 Solubilizers

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

DIGITAL CONTENT

1 Stock Recap #PipelineProspector, 114 News #PharmaBuzz

1 Stock Recap #PipelineProspector
114 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 13 Regulatory FDF Prices, 20 Annual Reports

3 US Medicaid Prescriptions
13 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

6 US Patents
4 US Exclusivities

REF. STANDARDS & IMPURITIES

2 USP, 5 Others

2 USP
5 Others

$ API Ref.Price (USD/KG) : 32,182 Xls

Filters

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filter Applicant Reset all filters

18 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 1SHILPA MEDICARE

filter Dosage Reset all filters

18 All

01 16POWDER;INTRAVENOUS, SUBCUTANEOUS

02 2TABLET;ORAL

filter Regulatory Info Reset all filters

18 All

01 2DISCN

02 16RX

filter Brand Name Reset all filters

18 All

01 15AZACITIDINE

02 2ONUREG

03 1VIDAZA

filter RLD Reset all filters

18 All

01 15No

02 3Yes

List of Suppliers

Product Main Page

01

DR REDDYS

CPhI North America

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

AMWC Asia-TDAC

Not Confirmed

ACCORD HLTHCARE

AMWC Asia-TDAC

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

AMWC Asia-TDAC

Not Confirmed

ACTAVIS LLC

AMWC Asia-TDAC

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

AMWC Asia-TDAC

Not Confirmed

BRISTOL-MYERS

AMWC Asia-TDAC

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

AMWC Asia-TDAC

Not Confirmed

CIPLA

AMWC Asia-TDAC

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 : 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

AMWC Asia-TDAC

Not Confirmed

EUROHLTH INTL SARL

AMWC Asia-TDAC

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

AMWC Asia-TDAC

Not Confirmed

LUPIN LTD

AMWC Asia-TDAC

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 :

Product Web Link

Digital Content

Corporate PDF

08

NATCO PHARMA LTD

AMWC Asia-TDAC

Not Confirmed

NATCO PHARMA LTD

AMWC Asia-TDAC

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

Product Web Link

Digital Content

Corporate PDF

09

SHILPA MEDICARE

AMWC Asia-TDAC

Not Confirmed

SHILPA MEDICARE

AMWC Asia-TDAC

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

Product Web Link

Digital Content

10

NORVIUM BIOSCIENCE

Country

AMWC Asia-TDAC

Not Confirmed

NORVIUM BIOSCIENCE

Country

AMWC Asia-TDAC

Not Confirmed

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Country

Virtual Booth

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

Virtual Booth

Digital Content

Website

Corporate PDF

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