01 1LABORATORI ALCHEMIA SRL
02 1Osaka Synthetic Organic Chemical Research Institute, Inc.
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
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PharmaCompass offers a list of Sivelestat Sodium Hydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sivelestat Sodium Hydrate manufacturer or Sivelestat Sodium Hydrate supplier for your needs.
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A AKOS015963357 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AKOS015963357, including repackagers and relabelers. The FDA regulates AKOS015963357 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AKOS015963357 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A AKOS015963357 supplier is an individual or a company that provides AKOS015963357 active pharmaceutical ingredient (API) or AKOS015963357 finished formulations upon request. The AKOS015963357 suppliers may include AKOS015963357 API manufacturers, exporters, distributors and traders.
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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 AKOS015963357 Drug Master File in Japan (AKOS015963357 JDMF) empowers AKOS015963357 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 AKOS015963357 JDMF during the approval evaluation for pharmaceutical products. At the time of AKOS015963357 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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