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.
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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 CCRIS 958 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CCRIS 958, including repackagers and relabelers. The FDA regulates CCRIS 958 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CCRIS 958 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 CCRIS 958 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CCRIS 958 supplier is an individual or a company that provides CCRIS 958 active pharmaceutical ingredient (API) or CCRIS 958 finished formulations upon request. The CCRIS 958 suppliers may include CCRIS 958 API manufacturers, exporters, distributors and traders.
click here to find a list of CCRIS 958 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 CCRIS 958 Drug Master File in Japan (CCRIS 958 JDMF) empowers CCRIS 958 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 CCRIS 958 JDMF during the approval evaluation for pharmaceutical products. At the time of CCRIS 958 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 CCRIS 958 suppliers with JDMF on PharmaCompass.
