01 1Zhejiang Chiral Medicine Chemicals Co. , Ltd.
02 1Zhejiang Wild Wind Pharmaceutical Co. , Ltd.
01 2Methyldopa hydrate
01 2China
Registration Number : 306MF10095
Registrant's Address : Nanyang Economy Development Zone, Xiaoshan, Hangzhou, Zhejiang, China
Initial Date of Registration : 2024-07-11
Latest Date of Registration : 2024-07-11
Registration Number : 226MF10099
Registrant's Address : Beijing Industrial Zone, Geshan Town, Dongyang, Zhejiang Province, China
Initial Date of Registration : 2014-05-14
Latest Date of Registration : 2014-05-14
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A Methyldopa 500 Tab 500mg manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methyldopa 500 Tab 500mg, including repackagers and relabelers. The FDA regulates Methyldopa 500 Tab 500mg manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methyldopa 500 Tab 500mg 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 Methyldopa 500 Tab 500mg supplier is an individual or a company that provides Methyldopa 500 Tab 500mg active pharmaceutical ingredient (API) or Methyldopa 500 Tab 500mg finished formulations upon request. The Methyldopa 500 Tab 500mg suppliers may include Methyldopa 500 Tab 500mg 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 Methyldopa 500 Tab 500mg Drug Master File in Japan (Methyldopa 500 Tab 500mg JDMF) empowers Methyldopa 500 Tab 500mg 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 Methyldopa 500 Tab 500mg JDMF during the approval evaluation for pharmaceutical products. At the time of Methyldopa 500 Tab 500mg 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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