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