01 1Janssen Pharmaceutical Sciences Unlimited Company
02 1Permakem Asia Co., Ltd.
03 1Sanyo Chemical Research Institute Co., Ltd.
04 1SperaNexus Inc.
01 1Outsiders regulations oxatomide (production only)
02 3Oxatomide
01 1Gabon
02 2Japan
03 1U.S.A
Registration Number : 217MF10048
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2009-04-22
Registration Number : 218MF10663
Registrant's Address : Little Island Industrial Estate, Little Island, Co. Cork, Ireland
Initial Date of Registration : 2006-07-24
Latest Date of Registration : 2006-07-24
Registration Number : 217MF10712
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2008-11-04
Oxatomide (for manufacturing only)
Registration Number : 217MF10169
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2005-05-31
Latest Date of Registration : 2008-07-24
A Oxatomide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxatomide, including repackagers and relabelers. The FDA regulates Oxatomide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxatomide 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 Oxatomide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxatomide supplier is an individual or a company that provides Oxatomide active pharmaceutical ingredient (API) or Oxatomide finished formulations upon request. The Oxatomide suppliers may include Oxatomide API manufacturers, exporters, distributors and traders.
click here to find a list of Oxatomide 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 Oxatomide Drug Master File in Japan (Oxatomide JDMF) empowers Oxatomide 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 Oxatomide JDMF during the approval evaluation for pharmaceutical products. At the time of Oxatomide 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 Oxatomide suppliers with JDMF on PharmaCompass.
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