01 1Catalent Pharma Solutions
02 1Katwijk Chemie
01 1ETHOSUXIMIDE
02 1ZARONTIN 0.25G SOFT GELATIN CAPSULES
01 1Netherlands
02 1U.S.A
01 1Active
02 1Inactive
01 1Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14835
Submission : 2000-04-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-09-26
DMF Number : 7937
Submission : 1989-02-16
Status : Active
Type : II
A Ethosuximide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethosuximide, including repackagers and relabelers. The FDA regulates Ethosuximide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethosuximide 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 Ethosuximide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ethosuximide supplier is an individual or a company that provides Ethosuximide active pharmaceutical ingredient (API) or Ethosuximide finished formulations upon request. The Ethosuximide suppliers may include Ethosuximide API manufacturers, exporters, distributors and traders.
click here to find a list of Ethosuximide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ethosuximide DMF (Drug Master File) is a document detailing the whole manufacturing process of Ethosuximide active pharmaceutical ingredient (API) in detail. Different forms of Ethosuximide DMFs exist exist since differing nations have different regulations, such as Ethosuximide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ethosuximide DMF submitted to regulatory agencies in the US is known as a USDMF. Ethosuximide USDMF includes data on Ethosuximide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ethosuximide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ethosuximide suppliers with USDMF on PharmaCompass.
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