ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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01 1ChemWerth Inc
02 1Shanghai Minbiotech
03 1Fishfa Biogenics
04 1TAPI Technology & API Services
05 1Sumar Biotech
06 1Aspen Bio
07 1Biopeptek Pharmaceuticals
08 1Concord Biotech
09 1Darmerica
10 1Hubei Honch Pharmaceutical
11 1Kyowa Hakko Bio
12 1Letco Medical
13 1Medisca
14 1Pcca
15 1Sicor
16 1Sicor Societa Italiana Corticosteroidi Srl
17 1Teva Pharmaceutical Industries
18 1Wuxi Fortune Pharmaceutical
19 1Zhejiang Hisun Chemical Co., Ltd.
20 2Zhejiang Hisun Pharmaceutical
21 1Zhejiang Huida Biotech
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01 7China
02 4India
03 2Israel
04 2Italy
05 1Japan
06 5U.S.A
07 1United Kingdom
08 2Blank
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01 6Active
02 3Inactive
03 15Blank
01 5Valid
02 1Withdrawn by Holder
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01 1304MF10010
02 23Blank
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01 1WC-0111
02 23Blank
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01 24Blank
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01 138779-0553
02 151927-0286
03 153183-7010
04 158623-0045
05 162158-0005
06 162991-2729
07 165050-0058
08 168254-0016
09 171052-644
10 173212-036
11 14Blank
01 24Blank
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
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-29
Pay. Date : 2012-11-09
DMF Number : 13791
Submission : 1998-09-01
Status : Active
Type : II
Available Reg Filing : CA, ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-08
Pay. Date : 2012-11-15
DMF Number : 25659
Submission : 2011-12-30
Status : Active
Type : II
Certificate Number : R1-CEP 2005-021 - Rev 00
Issue Date : 2011-01-25
Type : Chemical
Substance Number : 1655
Status : Withdrawn by Holder
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-21
Pay. Date : 2019-04-24
DMF Number : 33662
Submission : 2019-04-20
Status : Active
Type : II
Certificate Number : R0-CEP 2019-308 - Rev 00
Issue Date : 2021-02-25
Type : Chemical
Substance Number : 1655
Status : Valid
Date of Issue : 2022-12-16
Valid Till : 2025-07-02
Written Confirmation Number : WC-0111
Address of the Firm :
NDC Package Code : 68254-0016
Start Marketing Date : 2016-05-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13783
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 2012-013 - Rev 00
Issue Date : 2022-05-10
Type : Chemical
Substance Number : 1655
Status : Valid
NDC Package Code : 58623-0045
Start Marketing Date : 2019-08-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18599
Submission : 1988-07-14
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13521
Submission : 1998-09-01
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.
We have 21 companies offering Mito-C
Get in contact with the supplier of your choice: