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01 1EUROAPI Hungary Ltd.
01 1Dinoprost
01 1France
Registration Number : 221MF10190
Registrant's Address : To(´) utca 1-5. , 1045 Budapest, Hungary
Initial Date of Registration : 2009-08-18
Latest Date of Registration : 2009-08-18
A Dinoprost manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dinoprost, including repackagers and relabelers. The FDA regulates Dinoprost manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dinoprost 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 Dinoprost manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dinoprost supplier is an individual or a company that provides Dinoprost active pharmaceutical ingredient (API) or Dinoprost finished formulations upon request. The Dinoprost suppliers may include Dinoprost API manufacturers, exporters, distributors and traders.
click here to find a list of Dinoprost 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 Dinoprost Drug Master File in Japan (Dinoprost JDMF) empowers Dinoprost 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 Dinoprost JDMF during the approval evaluation for pharmaceutical products. At the time of Dinoprost 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 Dinoprost suppliers with JDMF on PharmaCompass.
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