01 1Sumitomo Chemical Co., Ltd.
01 1Japanese Pharmacopoeia trientine hydrochloride
01 1Japan
Japanese Pharmacopoeia Trientine Hydrochloride
Registration Number : 218MF10740
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2006-09-06
Latest Date of Registration : 2006-09-06
A Trientine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trientine, including repackagers and relabelers. The FDA regulates Trientine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trientine 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 Trientine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trientine supplier is an individual or a company that provides Trientine active pharmaceutical ingredient (API) or Trientine finished formulations upon request. The Trientine suppliers may include Trientine API manufacturers, exporters, distributors and traders.
click here to find a list of Trientine 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 Trientine Drug Master File in Japan (Trientine JDMF) empowers Trientine 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 Trientine JDMF during the approval evaluation for pharmaceutical products. At the time of Trientine 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 Trientine suppliers with JDMF on PharmaCompass.
We have 1 companies offering Trientine
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
