01 2Tsujimoto Chemical Industry Co., Ltd.
01 1Methylenedioxy salicylic acid promethazine
02 1Promethazine methylene di salicylate
01 2Japan
Promethazine methylene disalicylate
Registration Number : 219MF10270
Registrant's Address : Osaka Prefecture, Osaka City, Tsurumi Ward, Tsurumi 1-6-93
Initial Date of Registration : 2007-08-16
Latest Date of Registration : 2009-06-30
Promethazine methylenedisalicylate
Registration Number : 217MF11311
Registrant's Address : Osaka Prefecture, Osaka City, Tsurumi Ward, Tsurumi 1-6-88
Initial Date of Registration : 2005-12-22
Latest Date of Registration : 2006-04-07
A Histargan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Histargan, including repackagers and relabelers. The FDA regulates Histargan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Histargan 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 Histargan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Histargan supplier is an individual or a company that provides Histargan active pharmaceutical ingredient (API) or Histargan finished formulations upon request. The Histargan suppliers may include Histargan API manufacturers, exporters, distributors and traders.
click here to find a list of Histargan 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 Histargan Drug Master File in Japan (Histargan JDMF) empowers Histargan 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 Histargan JDMF during the approval evaluation for pharmaceutical products. At the time of Histargan 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 Histargan suppliers with JDMF on PharmaCompass.
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