01 1Midori Chemical Co., Ltd.
01 1Japan Standards of Pharmaceutical Ingredients simetride
01 1Japan
Simetridone, a non-Japanese Pharmacopoeia pharmaceutical ingredient
Registration Number : 217MF10877
Registrant's Address : 3-19-12 Kamiochiai, Shinjuku-ku, Tokyo
Initial Date of Registration : 2005-11-07
Latest Date of Registration : 2009-11-17
A Simetride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Simetride, including repackagers and relabelers. The FDA regulates Simetride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Simetride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Simetride supplier is an individual or a company that provides Simetride active pharmaceutical ingredient (API) or Simetride finished formulations upon request. The Simetride suppliers may include Simetride API manufacturers, exporters, distributors and traders.
click here to find a list of Simetride 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 Simetride Drug Master File in Japan (Simetride JDMF) empowers Simetride 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 Simetride JDMF during the approval evaluation for pharmaceutical products. At the time of Simetride 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 Simetride suppliers with JDMF on PharmaCompass.
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