01 1Excella GmbH & Co. K.G.
01 1Ganciclovir
01 1Luxembourg
Registration Number : 222MF10281
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2010-12-24
Latest Date of Registration : 2023-11-01
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PharmaCompass offers a list of Ganciclovir 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 Ganciclovir manufacturer or Ganciclovir supplier for your needs.
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PharmaCompass also assists you with knowing the Ganciclovir API Price utilized in the formulation of products. Ganciclovir API Price is not always fixed or binding as the Ganciclovir Price is obtained through a variety of data sources. The Ganciclovir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 2'-NDG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2'-NDG, including repackagers and relabelers. The FDA regulates 2'-NDG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2'-NDG 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 2'-NDG manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 2'-NDG supplier is an individual or a company that provides 2'-NDG active pharmaceutical ingredient (API) or 2'-NDG finished formulations upon request. The 2'-NDG suppliers may include 2'-NDG API manufacturers, exporters, distributors and traders.
click here to find a list of 2'-NDG 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 2'-NDG Drug Master File in Japan (2'-NDG JDMF) empowers 2'-NDG 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 2'-NDG JDMF during the approval evaluation for pharmaceutical products. At the time of 2'-NDG 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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