ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Alcami
03 1Apothecon Pharmaceuticals
04 1Ascensus Specialties
05 1GLAND PHARMA LIMITED
06 1Global Calcium
07 1Seratec SAS
08 1Viatris
01 6FOMEPIZOLE
02 1FOMEPIZOLE (4-METHYLPYRAZOLE)
03 1FP-059 (FOMEPIZOLE) DRUG SUBSTANCE
01 1France
02 3India
03 4U.S.A
01 8Active
01 3Complete
02 5Blank
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 : 19978
Submission : 2006-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19151
Submission : 2006-02-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19683
Submission : 2006-08-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-17
Pay. Date : 2024-07-11
DMF Number : 40058
Submission : 2024-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-15
Pay. Date : 2021-04-29
DMF Number : 35383
Submission : 2020-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36871
Submission : 2023-07-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20305
Submission : 2007-02-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-18
DMF Number : 19472
Submission : 2006-05-24
Status : Active
Type : II
A Fomepizole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fomepizole, including repackagers and relabelers. The FDA regulates Fomepizole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fomepizole 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 Fomepizole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fomepizole supplier is an individual or a company that provides Fomepizole active pharmaceutical ingredient (API) or Fomepizole finished formulations upon request. The Fomepizole suppliers may include Fomepizole API manufacturers, exporters, distributors and traders.
click here to find a list of Fomepizole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fomepizole DMF (Drug Master File) is a document detailing the whole manufacturing process of Fomepizole active pharmaceutical ingredient (API) in detail. Different forms of Fomepizole DMFs exist exist since differing nations have different regulations, such as Fomepizole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fomepizole DMF submitted to regulatory agencies in the US is known as a USDMF. Fomepizole USDMF includes data on Fomepizole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fomepizole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fomepizole suppliers with USDMF on PharmaCompass.
We have 8 companies offering Fomepizole
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