01 1Xellia Pharmaceuticals Ltd.
01 1Gramicidin
01 1Denmark
Registration Number : 218MF10936
Registrant's Address : H-1107 Budapest, Sza(´)lla(´)s u. 3. Hungary
Initial Date of Registration : 2006-11-21
Latest Date of Registration : 2006-11-21
A Gramicidin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gramicidin, including repackagers and relabelers. The FDA regulates Gramicidin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gramicidin 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 Gramicidin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gramicidin supplier is an individual or a company that provides Gramicidin active pharmaceutical ingredient (API) or Gramicidin finished formulations upon request. The Gramicidin suppliers may include Gramicidin API manufacturers, exporters, distributors and traders.
click here to find a list of Gramicidin 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 Gramicidin Drug Master File in Japan (Gramicidin JDMF) empowers Gramicidin 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 Gramicidin JDMF during the approval evaluation for pharmaceutical products. At the time of Gramicidin 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 Gramicidin suppliers with JDMF on PharmaCompass.
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