01 2BASF Company Ltd
02 1DSM Nutritional Products Ltd.
03 1Kyowa Pharma Chemical Co., Ltd.
01 1Japanese Pharmacopoeia riboflavin butyric acid ester (production only)
02 1Riboflavin
03 1Riboflavin Riboflavin
04 1Riboflavin Riboflavin Universal
01 1Germany
02 1Japan
03 1Netherlands
04 1Blank
Registration Number : 228MF10235
Registrant's Address : 14-16F KCCI Bldg. , 39, Sejongdaero, Jung-gu, Seoul, Republic of Korea
Initial Date of Registration : 2016-12-26
Latest Date of Registration : 2016-12-26
Registration Number : 217MF10986
Registrant's Address : 14-16F KCCI Bldg. , 39, Sejongdaero, Jung-gu, Seoul, Republic of Korea
Initial Date of Registration : 2005-11-21
Latest Date of Registration : 2010-06-04
Japanese Pharmacopoeia Riboflavin Butyrate (for manufacturing only)
Registration Number : 221MF10100
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2009-05-27
Latest Date of Registration : 2009-05-27
Registration Number : 217MF11283
Registrant's Address : Wurmisweg 576, CH-4303, Kaiseraugst, Switzerland
Initial Date of Registration : 2005-12-22
Latest Date of Registration : 2006-07-20
A Riboflavin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Riboflavin, including repackagers and relabelers. The FDA regulates Riboflavin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Riboflavin 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 Riboflavin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Riboflavin supplier is an individual or a company that provides Riboflavin active pharmaceutical ingredient (API) or Riboflavin finished formulations upon request. The Riboflavin suppliers may include Riboflavin API manufacturers, exporters, distributors and traders.
click here to find a list of Riboflavin 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 Riboflavin Drug Master File in Japan (Riboflavin JDMF) empowers Riboflavin 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 Riboflavin JDMF during the approval evaluation for pharmaceutical products. At the time of Riboflavin 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 Riboflavin suppliers with JDMF on PharmaCompass.
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