Registration Number : 222MF10097
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2010-03-17
Latest Date of Registration : 2019-10-18
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PharmaCompass offers a list of Hydroxyurea 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 Hydroxyurea manufacturer or Hydroxyurea supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydroxyurea manufacturer or Hydroxyurea supplier.
PharmaCompass also assists you with knowing the Hydroxyurea API Price utilized in the formulation of products. Hydroxyurea API Price is not always fixed or binding as the Hydroxyurea Price is obtained through a variety of data sources. The Hydroxyurea Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hydura manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydura, including repackagers and relabelers. The FDA regulates Hydura manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydura 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 Hydura manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydura supplier is an individual or a company that provides Hydura active pharmaceutical ingredient (API) or Hydura finished formulations upon request. The Hydura suppliers may include Hydura API manufacturers, exporters, distributors and traders.
click here to find a list of Hydura 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 Hydura Drug Master File in Japan (Hydura JDMF) empowers Hydura 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 Hydura JDMF during the approval evaluation for pharmaceutical products. At the time of Hydura 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 Hydura suppliers with JDMF on PharmaCompass.
