01 1Hebei Shengxue Dacheng Pharmaceutical Co. , Ltd.
01 1Streptomycin sulfate
01 1China
Registration Number : 229MF10076
Registrant's Address : No. 50 Shengxue Road, Luncheng Shijiazhuang, Hebei Province, China
Initial Date of Registration : 2017-04-11
Latest Date of Registration : 2017-04-11
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A Estreptomicina Normon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estreptomicina Normon, including repackagers and relabelers. The FDA regulates Estreptomicina Normon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estreptomicina Normon 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 Estreptomicina Normon supplier is an individual or a company that provides Estreptomicina Normon active pharmaceutical ingredient (API) or Estreptomicina Normon finished formulations upon request. The Estreptomicina Normon suppliers may include Estreptomicina Normon 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 Estreptomicina Normon Drug Master File in Japan (Estreptomicina Normon JDMF) empowers Estreptomicina Normon 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 Estreptomicina Normon JDMF during the approval evaluation for pharmaceutical products. At the time of Estreptomicina Normon 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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