01 1Katwijk Chemie bv
01 1Ethosuximide
01 1Netherlands
Registration Number : 217MF10735
Registrant's Address : Snijderstraat 6,2222 BA, Katwijk, ZH The Netherlands
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2024-11-20
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Ethosuximide Drug Master File in Japan (Ethosuximide JDMF) empowers Ethosuximide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Ethosuximide JDMF during the approval evaluation for pharmaceutical products. At the time of Ethosuximide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Ethosuximide suppliers with JDMF on PharmaCompass.
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