Registration Number : 217MF10049
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2010-03-09
A Bucolome manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bucolome, including repackagers and relabelers. The FDA regulates Bucolome manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bucolome API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Bucolome supplier is an individual or a company that provides Bucolome active pharmaceutical ingredient (API) or Bucolome finished formulations upon request. The Bucolome suppliers may include Bucolome API manufacturers, exporters, distributors and traders.
click here to find a list of Bucolome 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 Bucolome Drug Master File in Japan (Bucolome JDMF) empowers Bucolome 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 Bucolome JDMF during the approval evaluation for pharmaceutical products. At the time of Bucolome 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 Bucolome suppliers with JDMF on PharmaCompass.
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