01 1DSM Nutritional Products Ltd.
02 1F. Hoffmann-La Roche Limited.
01 2Cholecalciferol Cholecalciferol / Vitamin D3 Cr ystalline
01 1Netherlands
02 1Switzerland
Cholecalciferol / Vitamin D3 Crystalline
Registration Number : 218MF10105
Registrant's Address : Grenzacherstrasse 124, 4070 Basel, Switzerland
Initial Date of Registration : 2006-01-30
Latest Date of Registration : 2006-07-20
Cholecalciferol / Vitamin D3 Crystalline
Registration Number : 223MF10101
Registrant's Address : Wurmisweg 576, CH-4303, Kaiseraugst, Switzerland
Initial Date of Registration : 2011-07-11
Latest Date of Registration : 2011-07-11
A Cholecalciferol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cholecalciferol, including repackagers and relabelers. The FDA regulates Cholecalciferol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cholecalciferol 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 Cholecalciferol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cholecalciferol supplier is an individual or a company that provides Cholecalciferol active pharmaceutical ingredient (API) or Cholecalciferol finished formulations upon request. The Cholecalciferol suppliers may include Cholecalciferol API manufacturers, exporters, distributors and traders.
click here to find a list of Cholecalciferol 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 Cholecalciferol Drug Master File in Japan (Cholecalciferol JDMF) empowers Cholecalciferol 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 Cholecalciferol JDMF during the approval evaluation for pharmaceutical products. At the time of Cholecalciferol 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 Cholecalciferol suppliers with JDMF on PharmaCompass.
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