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List of Drug Master Files (DMF) of Azacitidine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Azacitidine
CAS 6974-32-9
CAS 931-86-2
USDMF

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Azacitidine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 21 USDMF, 3 JDMF, 6 EU WC, 8 KDMF, 16 NDC API, 27 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

150 Drugs in Development

150 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

158 FDF Dossiers, 17 FDA Orange Book, 15 Europe, 7 Canada, 101 Australia, 3 South Africa, 15 Listed Dossiers

158 FDF Dossiers
17 FDA Orange Book
15 Europe
7 Canada
101 Australia
3 South Africa
15 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 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
12 SPI Pharma
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, 11 Taste Masking, 10 Chewable & Orodispersible Aids, 9 Direct Compression, 5 Parenteral, 3 Disintegrants & Superdisintegrants, 3 Thickeners and Stabilizers, 3 Co-Processed Excipients, 3 Granulation, 2 Coating Systems & Additives, 1 API Stability Enhancers

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

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 110 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
110 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 13 Finished Drug Prices, 20 Annual Reports

3 US Medicaid Prescriptions
13 Finished Drug 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

4 USP, 5 Others

4 USP
5 Others

$ API Ref.Price (USD/KG) : 30,303 Xls

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21 All

01 1ChemWerth Inc

02 1Dr. Reddy\'s Laboratories

03 1Archimica

04 1Ash Stevens, Inc.

05 1Aurobindo Pharma Limited

06 1Hansoh Pharma

07 1Hetero Drugs

08 1ITF CHEMICAL LTDA

09 1Intas Pharmaceuticals

10 1Laurus Labs

11 1MSN Laboratories

12 1Polymed Therapeutics Inc.

13 1Qilu Antibiotics Pharmaceutical Co., Ltd.

14 1Reliance Life Sciences Private Limited

15 1ScinoPharm Taiwan, Ltd

16 1Shilpa Medicare

17 1Sun Pharmaceutical Industries Limited

18 1Teva API

19 1Viatris

20 2Blank

filter Subject Reset all filters

21 All

01 15-AZACYTIDINE

02 15AZACITIDINE

03 1AZACITIDINE USP

04 1AZACITIDINE [ROUTE CODE "AJ"]

05 1AZACITIDINE, NON-STERILE BULK DRUG SUBSTANCE

06 1AZACYTIDINE

07 1BULK PREPARATION OF 5-AZACYTIDINE

filter Country Reset all filters

21 All

01 1Brazil

02 2China

03 9India

04 1Israel

05 1Italy

06 1Taiwan

07 4U.S.A

08 2Blank

filter Status Reset all filters

21 All

01 17Active

02 4Inactive

filter GDUFA DMF Review Reset all filters

21 All

01 16Complete

02 5Blank

API Suppliers
USDMF
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Chemwerth Inc

CPhI Worldwide, Milan

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

Contact Supplier

Contact Supplier

Digital Content

Azacitidine

GDUFA

DMF Review : Complete

Rev. Date : 2023-01-26

Pay. Date : 2022-12-16

DMF Number : 23416

Submission : 2009-12-22

Status : Active

Type : II

Chemwerth Compnay Banner

Product Web Link

Digital Content

02

Dr Reddys Laboratories Ltd

CPhI Worldwide, Milan

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

Contact Supplier

Contact Supplier

Digital Content

Azacitidine

GDUFA

DMF Review : Complete

Rev. Date : 2020-11-20

Pay. Date : 2020-11-17

DMF Number : 23564

Submission : 2010-02-23

Status : Active

Type : II

Dr Reddy Company Banner

Product Web Link

Digital Content

03

Intas Pharmaceuticals Ltd

USDMF

Discovery on Target

Not Confirmed

03

Intas Pharmaceuticals Ltd

Discovery on Target

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

Azacitidine

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-20

Pay. Date : 2013-12-27

DMF Number : 27821

Submission : 2013-12-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Itf Chemical Ltda

USDMF

Discovery on Target

Not Confirmed

04

Itf Chemical Ltda

Discovery on Target

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

Azacytidine

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-27

Pay. Date : 2014-07-01

DMF Number : 27953

Submission : 2014-03-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Laurus Labs Ltd

USDMF

Discovery on Target

Not Confirmed

05

Laurus Labs Ltd

Discovery on Target

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

Azacitidine

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-03

Pay. Date : 2013-02-07

DMF Number : 26846

Submission : 2013-02-07

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

06

Msn Laboratories Private Ltd

USDMF

Discovery on Target

Not Confirmed

06

Msn Laboratories Private Ltd

Discovery on Target

Not Confirmed

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Digital Content

Azacitidine [route Code "aj"]

GDUFA

DMF Review : Complete

Rev. Date : 2018-09-05

Pay. Date : 2018-06-19

DMF Number : 28100

Submission : 2014-04-05

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

07

Chongqing Sintaho Pharmaceutical Co ...

USDMF

Discovery on Target

Not Confirmed

07

Chongqing Sintaho Pharmaceutical Co ...

Discovery on Target

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

Azacitidine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2016-10-06

Pay. Date : 2016-08-10

DMF Number : 28107

Submission : 2014-03-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Scinopharm Taiwan Ltd

USDMF

Discovery on Target

Not Confirmed

08

Scinopharm Taiwan Ltd

Discovery on Target

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

Azacitidine

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-04

Pay. Date : 2012-11-29

DMF Number : 22360

Submission : 2008-12-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

09

Shilpa Pharma Lifesciences Ltd

USDMF

Discovery on Target

Not Confirmed

09

Shilpa Pharma Lifesciences Ltd

Discovery on Target

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.

Post an Enquiry

Post an Enquiry

Digital Content

Azacitidine

GDUFA

DMF Review : Complete

Rev. Date : 2014-03-15

Pay. Date : 2013-09-23

DMF Number : 27487

Submission : 2013-09-23

Status : Active

Type : II

Product Web Link

Digital Content

10

Teva Pharmaceutical Industries Ltd

USDMF

Discovery on Target

Not Confirmed

10

Teva Pharmaceutical Industries Ltd

Discovery on Target

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.

Post an Enquiry

Post an Enquiry

Digital Content

Azacitidine

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-24

Pay. Date : 2012-11-13

DMF Number : 26126

Submission : 2012-06-04

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

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Azacitidine Manufacturers | Traders | Suppliers

Azacitidine Manufacturers, Traders, Suppliers 1

49

We have 19 companies offering Azacitidine

Get in contact with the supplier of your choice:

ChemWerth Inc
Dr. Reddy\'s Laboratories
Archimica
Ash Stevens, Inc.
Aurobindo Pharma Limited
Hansoh Pharma
Hetero Drugs
Intas Pharmaceuticals
ITF CHEMICAL LTDA
Laurus Labs
MSN Laboratories
Polymed Therapeutics Inc.
Qilu Antibiotics Pharmaceutical Co., Ltd.
Reliance Life Sciences Private Limited
ScinoPharm Taiwan, Ltd
Shilpa Medicare
Sun Pharmaceutical Industries Limited
Teva API
Viatris

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