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
99
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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vitamin D manufacturer or Vitamin D supplier.
PharmaCompass also assists you with knowing the Vitamin D API Price utilized in the formulation of products. Vitamin D API Price is not always fixed or binding as the Vitamin D Price is obtained through a variety of data sources. The Vitamin D Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vitamin D2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin D2, including repackagers and relabelers. The FDA regulates Vitamin D2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin D2 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 Vitamin D2 supplier is an individual or a company that provides Vitamin D2 active pharmaceutical ingredient (API) or Vitamin D2 finished formulations upon request. The Vitamin D2 suppliers may include Vitamin D2 API manufacturers, exporters, distributors and traders.
click here to find a list of Vitamin D2 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 D2 Drug Master File in Japan (Vitamin D2 JDMF) empowers Vitamin D2 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 D2 JDMF during the approval evaluation for pharmaceutical products. At the time of Vitamin D2 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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