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

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 Veranova (1)

03 Dr. Reddy's Laboratories (1)

04 CQ INTERNATIONAL CO INC (1)

05 Emcure Pharmaceuticals (1)

06 Farmhispania (1)

07 Fresenius Kabi AB Brunna (1)

08 Hansoh Pharma (1)

09 ITF CHEMICAL LTDA (1)

10 Intas Pharmaceuticals (1)

11 MSN Laboratories (1)

12 Pfanstiehl (1)

13 Qilu Pharmaceutical (1)

14 Reliance Life Sciences Private Limited (1)

15 ScinoPharm Taiwan, Ltd (2)

16 Shilpa Medicare (1)

17 Sun Pharmaceutical Industries Limited (1)

18 Wuhan Calmland Pharmaceuticals (1)

19 Zhejiang Hisun Pharmaceutical (1)

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01 DECITABINE (18)

02 DECITABINE MONOHYDRATE (1)

03 DECITABINE, NON-STERILE BULK DRUG SUBSTANCE (1)

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01 Brazil (1)

02 China (4)

03 India (8)

04 Spain (1)

05 Sweden (1)

06 Taiwan (2)

07 U.S.A (3)

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01 Active (18)

02 Inactive (2)

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01 Complete (10)

02 Blank (10)

URL Supplier Web Content
25988
Active
2012-04-23
N/A
II
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URL Supplier Web Content
26948
Active
2013-03-29
Complete
2014-05-13
2014-01-22
II
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URL Supplier Web Content
25532
Active
2011-12-16
N/A
II
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URL Supplier Web Content
25317
Active
2011-09-21
N/A
II
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URL Supplier Web Content
26708
Active
2012-12-11
Complete
2013-07-08
2013-01-18
II
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URL Supplier Web Content
23387
Active
2009-12-18
Complete
2013-05-14
2012-12-06
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URL Supplier Web Content
26256
Active
2013-02-21
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Looking for 2353-33-5 / Decitabine API manufacturers, exporters & distributors?

Decitabine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Decitabine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Decitabine manufacturer or Decitabine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Decitabine manufacturer or Decitabine supplier.

PharmaCompass also assists you with knowing the Decitabine API Price utilized in the formulation of products. Decitabine API Price is not always fixed or binding as the Decitabine Price is obtained through a variety of data sources. The Decitabine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Decitabine

Synonyms

5-aza-2'-deoxycytidine, 2353-33-5, Dacogen, 2'-deoxy-5-azacytidine, 5-azadeoxycytidine, Azadc

Cas Number

2353-33-5

Unique Ingredient Identifier (UNII)

776B62CQ27

About Decitabine

An azacitidine derivative and antineoplastic antimetabolite. It inhibits DNA methyltransferase to re-activate silent genes, limiting METASTASIS and NEOPLASM DRUG RESISTANCE. Decitabine is used in the treatment of MYELODISPLASTIC SYNDROMES, and ACUTE MYELOID LEUKEMIA.

Decitabine Manufacturers

A Decitabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Decitabine, including repackagers and relabelers. The FDA regulates Decitabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Decitabine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Decitabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Decitabine Suppliers

A Decitabine supplier is an individual or a company that provides Decitabine active pharmaceutical ingredient (API) or Decitabine finished formulations upon request. The Decitabine suppliers may include Decitabine API manufacturers, exporters, distributors and traders.

click here to find a list of Decitabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Decitabine USDMF

A Decitabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Decitabine active pharmaceutical ingredient (API) in detail. Different forms of Decitabine DMFs exist exist since differing nations have different regulations, such as Decitabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Decitabine DMF submitted to regulatory agencies in the US is known as a USDMF. Decitabine USDMF includes data on Decitabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Decitabine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Decitabine suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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