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 Vitamin D3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin D3, including repackagers and relabelers. The FDA regulates Vitamin D3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin D3 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 Vitamin D3 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vitamin D3 supplier is an individual or a company that provides Vitamin D3 active pharmaceutical ingredient (API) or Vitamin D3 finished formulations upon request. The Vitamin D3 suppliers may include Vitamin D3 API manufacturers, exporters, distributors and traders.
click here to find a list of Vitamin D3 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 Vitamin D3 Drug Master File in Japan (Vitamin D3 JDMF) empowers Vitamin D3 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 Vitamin D3 JDMF during the approval evaluation for pharmaceutical products. At the time of Vitamin D3 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 Vitamin D3 suppliers with JDMF on PharmaCompass.
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