01 1Midori Chemical Co., Ltd.
01 1Japanese Pharmacopoeia hydrochloric acid tolperisone
01 1Japan
Tolperisone Hydrochloride, Japanese Pharmacopoeia
Registration Number : 217MF10876
Registrant's Address : 3-19-12 Kamiochiai, Shinjuku-ku, Tokyo
Initial Date of Registration : 2005-11-07
Latest Date of Registration : 2006-07-03
A Tolperisone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolperisone, including repackagers and relabelers. The FDA regulates Tolperisone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolperisone 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 Tolperisone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tolperisone supplier is an individual or a company that provides Tolperisone active pharmaceutical ingredient (API) or Tolperisone finished formulations upon request. The Tolperisone suppliers may include Tolperisone API manufacturers, exporters, distributors and traders.
click here to find a list of Tolperisone 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 Tolperisone Drug Master File in Japan (Tolperisone JDMF) empowers Tolperisone 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 Tolperisone JDMF during the approval evaluation for pharmaceutical products. At the time of Tolperisone 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 Tolperisone suppliers with JDMF on PharmaCompass.
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