Registration Number : 218MF10226
Registrant's Address : Viale Ortles 12 Milan Italy
Initial Date of Registration : 2006-02-16
Latest Date of Registration : 2022-02-17
A Colchicine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colchicine, including repackagers and relabelers. The FDA regulates Colchicine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colchicine 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 Colchicine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Colchicine supplier is an individual or a company that provides Colchicine active pharmaceutical ingredient (API) or Colchicine finished formulations upon request. The Colchicine suppliers may include Colchicine API manufacturers, exporters, distributors and traders.
click here to find a list of Colchicine 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 Colchicine Drug Master File in Japan (Colchicine JDMF) empowers Colchicine 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 Colchicine JDMF during the approval evaluation for pharmaceutical products. At the time of Colchicine 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 Colchicine suppliers with JDMF on PharmaCompass.
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