01 1Synthesia, a. s.
01 1Japanese Pharmacopoeia ergocalciferol (production only)
01 1Czech Republic
Japanese Pharmacopoeia Ergocalciferol (for manufacturing purposes 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
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PharmaCompass offers a list of Vitamin D API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Vitamin D manufacturer or Vitamin D supplier for your needs.
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A Geltabs manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Geltabs, including repackagers and relabelers. The FDA regulates Geltabs manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Geltabs API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Geltabs supplier is an individual or a company that provides Geltabs active pharmaceutical ingredient (API) or Geltabs finished formulations upon request. The Geltabs suppliers may include Geltabs API manufacturers, exporters, distributors and traders.
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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 Geltabs Drug Master File in Japan (Geltabs JDMF) empowers Geltabs 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 Geltabs JDMF during the approval evaluation for pharmaceutical products. At the time of Geltabs JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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