ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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01 1ChemWerth Inc
02 1TAPI Technology & API Services
03 1Concord Biotech
04 1Hubei Honch Pharmaceutical
05 1Kyowa Hakko Bio
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01 5MITOMYCIN
02 2MITOMYCIN USP
03 1MITOMYCIN USP (ALTERNATIVE PROCESS)
04 1MITOMYCIN-C CONJUGATED MURINE MONOCLONAL ANTIBODIES
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33811
Submission : 2019-11-04
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-09
DMF Number : 13791
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-21
Pay. Date : 2019-04-24
DMF Number : 33662
Submission : 2019-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2025-03-27
Pay. Date : 2025-01-14
DMF Number : 37462
Submission : 2023-10-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13521
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-23
Pay. Date : 2020-09-25
DMF Number : 34866
Submission : 2020-09-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-08
Pay. Date : 2012-11-15
DMF Number : 25659
Submission : 2011-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13783
Submission : 1998-09-01
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18599
Submission : 1988-07-14
Status : Inactive
Type : II
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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.
A Mitosol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitosol, including repackagers and relabelers. The FDA regulates Mitosol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitosol 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 Mitosol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitosol supplier is an individual or a company that provides Mitosol active pharmaceutical ingredient (API) or Mitosol finished formulations upon request. The Mitosol suppliers may include Mitosol API manufacturers, exporters, distributors and traders.
click here to find a list of Mitosol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mitosol DMF (Drug Master File) is a document detailing the whole manufacturing process of Mitosol active pharmaceutical ingredient (API) in detail. Different forms of Mitosol DMFs exist exist since differing nations have different regulations, such as Mitosol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mitosol DMF submitted to regulatory agencies in the US is known as a USDMF. Mitosol USDMF includes data on Mitosol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mitosol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mitosol suppliers with USDMF on PharmaCompass.
We have 7 companies offering Mitosol
Get in contact with the supplier of your choice: