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