01 1Cambrex Profarmaco Milano S. r. l.
02 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
01 1Estazolam
02 1Only the Japanese Pharmacopoeia estazolam production
01 1Japan
02 1U.S.A
Registration Number : 222MF10060
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2010-02-17
Latest Date of Registration : 2020-07-29
Japanese Pharmacopoeia Estazolam For manufacturing only
Registration Number : 217MF10395
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2005-08-10
Latest Date of Registration : 2009-07-30
A Esilgan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esilgan, including repackagers and relabelers. The FDA regulates Esilgan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esilgan 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 Esilgan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esilgan supplier is an individual or a company that provides Esilgan active pharmaceutical ingredient (API) or Esilgan finished formulations upon request. The Esilgan suppliers may include Esilgan API manufacturers, exporters, distributors and traders.
click here to find a list of Esilgan 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 Esilgan Drug Master File in Japan (Esilgan JDMF) empowers Esilgan 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 Esilgan JDMF during the approval evaluation for pharmaceutical products. At the time of Esilgan 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 Esilgan suppliers with JDMF on PharmaCompass.
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