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 Mito-C manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mito-C, including repackagers and relabelers. The FDA regulates Mito-C manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mito-C 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 Mito-C manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mito-C supplier is an individual or a company that provides Mito-C active pharmaceutical ingredient (API) or Mito-C finished formulations upon request. The Mito-C suppliers may include Mito-C API manufacturers, exporters, distributors and traders.
click here to find a list of Mito-C suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mito-C DMF (Drug Master File) is a document detailing the whole manufacturing process of Mito-C active pharmaceutical ingredient (API) in detail. Different forms of Mito-C DMFs exist exist since differing nations have different regulations, such as Mito-C USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mito-C DMF submitted to regulatory agencies in the US is known as a USDMF. Mito-C USDMF includes data on Mito-C's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mito-C USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mito-C suppliers with USDMF on PharmaCompass.
We have 7 companies offering Mito-C
Get in contact with the supplier of your choice: