ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Shanghai Minbiotech
03 1Fishfa Biogenics
04 1TAPI Technology & API Services
05 1Aspen Biopharma Labs
06 1Concord Biotech
07 1Hubei Honch Pharmaceutical
08 1Kyowa Hakko Bio
09 1Sicor Societa Italiana Corticosteroidi Srl
10 1Sumar Biotech
11 1Teva Pharmaceutical Industries
12 1Wuxi Fortune Pharmaceutical Co., Ltd
13 2Zhejiang Hisun Pharmaceutical
14 1Zhejiang Huida Biotech
15 1Blank
01 6China
02 4India
03 2Israel
04 1Italy
05 1Japan
06 1U.S.A
07 1Blank
01 6Active
02 3Inactive
03 7Blank
01 5Valid
02 1Withdrawn by Holder
03 10Blank
01 1304MF10010
02 15Blank
01 1WC-0111
02 15Blank
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.
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 : 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 : 2019-09-23
Valid Till : 2022-07-02
Written Confirmation Number : WC-0111
Address of the Firm :
NDC Package Code : 68254-0016
Start Marketing Date : 2016-05-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37462
Submission : 2023-10-10
Status : Active
Type : II
Certificate Number : CEP 2022-400 - Rev 01
Issue Date : 2024-04-26
Type : Chemical
Substance Number : 1655
Status : Valid
NDC Package Code : 62158-0005
Start Marketing Date : 2019-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-23
Pay. Date : 2020-09-25
DMF Number : 34866
Submission : 2020-09-14
Status : Active
Type : II
Certificate Number : R1-CEP 2016-034 - Rev 00
Issue Date : 2022-11-09
Type : Chemical
Substance Number : 1655
Status : Valid
NDC Package Code : 65050-0058
Start Marketing Date : 2020-03-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13521
Submission : 1998-09-01
Status : Inactive
Type : II
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
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.
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.
We have 14 companies offering Mitomycin
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