01 1Sekisui Medical Co., Ltd.
01 1Indigo carmine
01 1Japan
Registration Number : 217MF10769
Registrant's Address : 2-1-3 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-20
Latest Date of Registration : 2009-07-09
A Indigo Carmine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indigo Carmine, including repackagers and relabelers. The FDA regulates Indigo Carmine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indigo Carmine 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 Indigo Carmine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indigo Carmine supplier is an individual or a company that provides Indigo Carmine active pharmaceutical ingredient (API) or Indigo Carmine finished formulations upon request. The Indigo Carmine suppliers may include Indigo Carmine API manufacturers, exporters, distributors and traders.
click here to find a list of Indigo Carmine 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 Indigo Carmine Drug Master File in Japan (Indigo Carmine JDMF) empowers Indigo Carmine 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 Indigo Carmine JDMF during the approval evaluation for pharmaceutical products. At the time of Indigo Carmine 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 Indigo Carmine suppliers with JDMF on PharmaCompass.
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