01 1LABORATORI ALCHEMIA SRL
02 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
03 1Procos S. p. A.
04 1Shiono Finesse Co., Ltd.
01 1Japanese Pharmacopoeia Sivelestat sodium hydrate production-only
02 2Sivelestat sodium hydrate
03 1Sivelestat sodium hydrate "SFL"
01 2Italy
02 2Japan
Registration Number : 225MF10154
Registrant's Address : Via San Faustino, 68 20134 MILANO-Italy
Initial Date of Registration : 2013-08-09
Latest Date of Registration : 2013-08-09
Japanese Pharmacopoeia Sivelestat Sodium Hydrate For manufacturing purposes only
Registration Number : 226MF10229
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2014-12-08
Latest Date of Registration : 2014-12-08
Registration Number : 225MF10161
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2013-08-14
Latest Date of Registration : 2013-08-14
Sivelestat sodium hydrate "SFL"
Registration Number : 218MF10428
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 3-1-6
Initial Date of Registration : 2006-04-27
Latest Date of Registration : 2014-05-29
A Sivelestat Sodium Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sivelestat Sodium Hydrate, including repackagers and relabelers. The FDA regulates Sivelestat Sodium Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sivelestat Sodium Hydrate supplier is an individual or a company that provides Sivelestat Sodium Hydrate active pharmaceutical ingredient (API) or Sivelestat Sodium Hydrate finished formulations upon request. The Sivelestat Sodium Hydrate suppliers may include Sivelestat Sodium Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate Drug Master File in Japan (Sivelestat Sodium Hydrate JDMF) empowers Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate suppliers with JDMF on PharmaCompass.
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