01 1Active Pharma Inc.
01 1Japanese Pharmacopoeia tolnaftate (production only)
01 1Japan
Japanese Pharmacopoeia Tolnaftate (for manufacturing only)
Registration Number : 217MF10195
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-08
Latest Date of Registration : 2020-06-04
A Tolnaftate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolnaftate, including repackagers and relabelers. The FDA regulates Tolnaftate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolnaftate 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 Tolnaftate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tolnaftate supplier is an individual or a company that provides Tolnaftate active pharmaceutical ingredient (API) or Tolnaftate finished formulations upon request. The Tolnaftate suppliers may include Tolnaftate API manufacturers, exporters, distributors and traders.
click here to find a list of Tolnaftate 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 Tolnaftate Drug Master File in Japan (Tolnaftate JDMF) empowers Tolnaftate 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 Tolnaftate JDMF during the approval evaluation for pharmaceutical products. At the time of Tolnaftate 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 Tolnaftate suppliers with JDMF on PharmaCompass.
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