01 1Southwest Synthetic Pharmaceutical Corp. , Ltd.
01 1Sulfadiazine
01 1China
Registration Number : 228MF10135
Registrant's Address : No. 22, Founder Avenue, Shuitu Township, Beibei District, Chongqing 400714, P. R. Chi...
Initial Date of Registration : 2016-07-27
Latest Date of Registration : 2016-07-27
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A SULPHAZINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SULPHAZINE, including repackagers and relabelers. The FDA regulates SULPHAZINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SULPHAZINE 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 SULPHAZINE supplier is an individual or a company that provides SULPHAZINE active pharmaceutical ingredient (API) or SULPHAZINE finished formulations upon request. The SULPHAZINE suppliers may include SULPHAZINE API manufacturers, exporters, distributors and traders.
click here to find a list of SULPHAZINE 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 SULPHAZINE Drug Master File in Japan (SULPHAZINE JDMF) empowers SULPHAZINE 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 SULPHAZINE JDMF during the approval evaluation for pharmaceutical products. At the time of SULPHAZINE 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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