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Athena Athena

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

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01 Fareva (1)

02 Axplora (1)

03 Apicore LLC (1)

04 Archimica (1)

05 ChemPacific Corp (1)

06 DMFs Not Supported (1)

07 Emcure Pharmaceuticals (2)

08 Fresenius Kabi AB Brunna (1)

09 Shilpa Medicare (1)

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01 BUSULFAN (5)

02 BUSULFAN DRUG SUBSTANCE (1)

03 BUSULFAN USP (3)

04 PREMIX FOR BUSULFAN (WITHOUT ACTIVE) (1)

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01 Germany (1)

02 India (4)

03 Italy (1)

04 Luxembourg (1)

05 Sweden (1)

06 U.S.A (1)

07 Blank (1)

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01 Active (8)

02 Inactive (2)

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01 Complete (6)

02 Blank (4)

25933
Active
2012-03-27
Complete
2013-08-08
2012-12-17
II
Axplora CB

Biotechgate Digital

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
23924
Active
2010-08-05
Complete
2015-06-10
2015-05-27
II
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URL Supplier Web Content
25393
Inactive
2011-10-18
N/A
II
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URL Supplier Web Content
21126
Active
2007-12-12
N/A
II
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ARTHUR GROUP LLC

Contact Supplier
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Virtual Booth Virtual Booth
Digital Content Digital Content
URL Supplier Web Content
25667
Active
2012-02-02
Complete
2013-06-25
2012-11-21
II
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URL Supplier Web Content
25433
Active
2011-12-29
Complete
2014-05-29
2014-01-22
II
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URL Supplier Web Content
25836
Inactive
2012-04-01
N/A
IV
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URL Supplier Web Content
24385
Active
2010-11-30
N/A
II
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URL Supplier Web Content
25491
Active
2011-12-07
Complete
2013-07-02
2012-12-19
II
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Looking for 55-98-1 / Busulfan API manufacturers, exporters & distributors?

Busulfan manufacturers, exporters & distributors 1

70

PharmaCompass offers a list of Busulfan 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 Busulfan manufacturer or Busulfan supplier for your needs.

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

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

API | Excipient name

Busulfan

Synonyms

55-98-1, Myleran, Busulphan, Sulphabutin, Leucosulfan, Busulfex

Cas Number

55-98-1

Unique Ingredient Identifier (UNII)

G1LN9045DK

About Busulfan

An alkylating agent having a selective immunosuppressive effect on BONE MARROW. It has been used in the palliative treatment of chronic myeloid leukemia (MYELOID LEUKEMIA, CHRONIC), but although symptomatic relief is provided, no permanent remission is brought about. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), busulfan is listed as a known carcinogen.

Busulfan Manufacturers

A Busulfan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Busulfan, including repackagers and relabelers. The FDA regulates Busulfan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Busulfan 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 Busulfan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Busulfan Suppliers

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

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

Busulfan USDMF

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

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

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

Busulfan Manufacturers | Traders | Suppliers

Busulfan Manufacturers, Traders, Suppliers 1
21

We have 8 companies offering Busulfan

Get in contact with the supplier of your choice:

  1. Fareva
  2. Axplora
  3. Apicore LLC
  4. Archimica
  5. ChemPacific Corp
  6. Emcure Pharmaceuticals
  7. Fresenius Kabi AB Brunna
  8. Shilpa Medicare
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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