01 1Synthesia, a. s.
01 1Japanese Pharmacopoeia ergocalciferol (production only)
01 1Czech Republic
Japanese Pharmacopoeia Ergocalciferol (for manufacturing only)
Registration Number : 218MF10696
Registrant's Address : Semtin 103, 530 02 Pardubice, Czech Republic
Initial Date of Registration : 2006-08-11
Latest Date of Registration : 2015-11-02
A Ergocalciferol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ergocalciferol, including repackagers and relabelers. The FDA regulates Ergocalciferol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ergocalciferol 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 Ergocalciferol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ergocalciferol supplier is an individual or a company that provides Ergocalciferol active pharmaceutical ingredient (API) or Ergocalciferol finished formulations upon request. The Ergocalciferol suppliers may include Ergocalciferol API manufacturers, exporters, distributors and traders.
click here to find a list of Ergocalciferol 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 Ergocalciferol Drug Master File in Japan (Ergocalciferol JDMF) empowers Ergocalciferol 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 Ergocalciferol JDMF during the approval evaluation for pharmaceutical products. At the time of Ergocalciferol 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 Ergocalciferol suppliers with JDMF on PharmaCompass.
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