01 1GEDEON RICHTER Plc.
01 1Estetrol hydrate
01 1Hungary
Registration Number : 305MF10111
Registrant's Address : BUDAPEST, GYOMROI UT 19-21, HUNGARY
Initial Date of Registration : 2023-09-26
Latest Date of Registration : 2023-09-26
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PharmaCompass offers a list of Estetrol 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 Estetrol manufacturer or Estetrol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Estetrol manufacturer or Estetrol supplier.
PharmaCompass also assists you with knowing the Estetrol API Price utilized in the formulation of products. Estetrol API Price is not always fixed or binding as the Estetrol Price is obtained through a variety of data sources. The Estetrol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Estetrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estetrol, including repackagers and relabelers. The FDA regulates Estetrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estetrol 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 Estetrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estetrol supplier is an individual or a company that provides Estetrol active pharmaceutical ingredient (API) or Estetrol finished formulations upon request. The Estetrol suppliers may include Estetrol API manufacturers, exporters, distributors and traders.
click here to find a list of Estetrol 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 Estetrol Drug Master File in Japan (Estetrol JDMF) empowers Estetrol 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 Estetrol JDMF during the approval evaluation for pharmaceutical products. At the time of Estetrol 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 Estetrol suppliers with JDMF on PharmaCompass.
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