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

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01 ChemWerth Inc (1)

02 Concord Biotech (1)

03 Hubei Honch Pharmaceutical (1)

04 Kyowa Hakko Bio (1)

05 MicroBiopharm Japan Co., Ltd. (1)

06 Teva API (1)

07 Wuxi Fortune Pharmaceutical Co., Ltd (1)

08 Zhejiang Hisun Pharmaceutical (2)

09 Blank (1)

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01 MITOMYCIN (6)

02 MITOMYCIN USP (2)

03 MITOMYCIN USP (ALTERNATIVE PROCESS) (1)

04 MITOMYCIN-C CONJUGATED MURINE MONOCLONAL ANTIBODIES (1)

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01 China (4)

02 India (1)

03 Israel (1)

04 Japan (2)

05 U.S.A (1)

06 Blank (1)

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01 Active (6)

02 Inactive (4)

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01 Complete (4)

02 Blank (6)

URL Supplier Web Content
33662
Active
2019-04-20
Complete
2019-10-21
2019-04-24
II
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URL Supplier Web Content
37462
Active
2023-10-10
N/A
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URL Supplier Web Content
13521
Inactive
1998-09-01
N/A
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URL Supplier Web Content
13785
Inactive
1998-09-01
N/A
II
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URL Supplier Web Content
13791
Active
1998-09-01
Complete
2012-11-29
2012-11-09
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URL Supplier Web Content
34866
Active
2020-09-14
Complete
2021-03-23
2020-09-25
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URL Supplier Web Content
25659
Active
2011-12-30
Complete
2013-10-08
2012-11-15
II
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URL Supplier Web Content
13783
Inactive
1998-09-01
N/A
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BIOLOGICAL THERAPY INSTITUTE

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18599
Inactive
1988-07-14
N/A
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Looking for 50-07-7 / Mitomycin API manufacturers, exporters & distributors?

Mitomycin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mitomycin

Synonyms

50-07-7, Ametycine, Mutamycin, Mitomycin-c, Mitocin-c, Mytozytrex

Cas Number

50-07-7

Unique Ingredient Identifier (UNII)

50SG953SK6

About Mitomycin

An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.

Mitomycin Manufacturers

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

Mitomycin Suppliers

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

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

Mitomycin USDMF

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

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

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

Mitomycin Manufacturers | Traders | Suppliers

Mitomycin Manufacturers, Traders, Suppliers 1
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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