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 MolPort-000-883-864 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MolPort-000-883-864, including repackagers and relabelers. The FDA regulates MolPort-000-883-864 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MolPort-000-883-864 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 MolPort-000-883-864 supplier is an individual or a company that provides MolPort-000-883-864 active pharmaceutical ingredient (API) or MolPort-000-883-864 finished formulations upon request. The MolPort-000-883-864 suppliers may include MolPort-000-883-864 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 MolPort-000-883-864 Drug Master File in Japan (MolPort-000-883-864 JDMF) empowers MolPort-000-883-864 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 MolPort-000-883-864 JDMF during the approval evaluation for pharmaceutical products. At the time of MolPort-000-883-864 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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