01 1DSM Nutritional Products Ltd.
02 1Sun Chemical Co., Ltd.
01 1Biotin Biotin
02 1d- biotin
01 1China
02 1Netherlands
Registration Number : 217MF11122
Registrant's Address : Wurmisweg 576, CH-4303, Kaiseraugst, Switzerland
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2006-11-15
Registration Number : 217MF10344
Registrant's Address : 29-3 Shinmachi, Yashio City, Saitama Prefecture
Initial Date of Registration : 2005-07-27
Latest Date of Registration : 2006-03-24
A Biotin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biotin, including repackagers and relabelers. The FDA regulates Biotin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biotin 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 Biotin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Biotin supplier is an individual or a company that provides Biotin active pharmaceutical ingredient (API) or Biotin finished formulations upon request. The Biotin suppliers may include Biotin API manufacturers, exporters, distributors and traders.
click here to find a list of Biotin 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 Biotin Drug Master File in Japan (Biotin JDMF) empowers Biotin 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 Biotin JDMF during the approval evaluation for pharmaceutical products. At the time of Biotin 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 Biotin suppliers with JDMF on PharmaCompass.
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