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