01 1APOTECNIA S. A.
02 1HANMI FINE CHEMICAL CO. , LTD.
03 1JW Pharmaceutical Corporation
04 1Tianish Laboratories Private Limited
05 1Vasudha Pharma Chem Limited
01 5Itraconazole
01 1France
02 1India
03 2South Korea
04 1U.S.A
Registration Number : 218MF10981
Registrant's Address : CARRETERA DE ZENETA, 149.30588 BENIEL, MURCIA, SPAIN
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2006-12-01
Registration Number : 222MF10208
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2010-07-26
Latest Date of Registration : 2010-07-26
Registration Number : 218MF10470
Registrant's Address : 2477, Nambusunhwan-ro Seocho-gu, Seoul, Republic of Korea
Initial Date of Registration : 2006-04-27
Latest Date of Registration : 2023-04-12
Registration Number : 303MF10166
Registrant's Address : 78/A, Bengalrao Nagar, Hyderabad-500 038, Telangana State, India.
Initial Date of Registration : 2021-11-25
Latest Date of Registration : 2021-11-25
Registration Number : 219MF10105
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2007-03-23
Latest Date of Registration : 2023-11-01
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A Itraconazole, Sporanox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Itraconazole, Sporanox, including repackagers and relabelers. The FDA regulates Itraconazole, Sporanox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Itraconazole, Sporanox API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Itraconazole, Sporanox supplier is an individual or a company that provides Itraconazole, Sporanox active pharmaceutical ingredient (API) or Itraconazole, Sporanox finished formulations upon request. The Itraconazole, Sporanox suppliers may include Itraconazole, Sporanox API manufacturers, exporters, distributors and traders.
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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 Itraconazole, Sporanox Drug Master File in Japan (Itraconazole, Sporanox JDMF) empowers Itraconazole, Sporanox 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 Itraconazole, Sporanox JDMF during the approval evaluation for pharmaceutical products. At the time of Itraconazole, Sporanox JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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