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