01 1Qilu Antibiotics Pharmaceutical Co. , Ltd.
01 1Cefepime dihydrochloride hydrate L- arginine mixture
01 1China
Cefepime hydrochloride hydrate L-arginine mixture
Registration Number : 225MF10112
Registrant's Address : No. 849 Dongjia Town, Licheng District, Jinan, Shandong, China
Initial Date of Registration : 2013-06-05
Latest Date of Registration : 2021-03-01
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A Cefepime Mixture With Arginine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefepime Mixture With Arginine, including repackagers and relabelers. The FDA regulates Cefepime Mixture With Arginine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefepime Mixture With Arginine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Cefepime Mixture With Arginine supplier is an individual or a company that provides Cefepime Mixture With Arginine active pharmaceutical ingredient (API) or Cefepime Mixture With Arginine finished formulations upon request. The Cefepime Mixture With Arginine suppliers may include Cefepime Mixture With Arginine 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 Cefepime Mixture With Arginine Drug Master File in Japan (Cefepime Mixture With Arginine JDMF) empowers Cefepime Mixture With Arginine 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 Cefepime Mixture With Arginine JDMF during the approval evaluation for pharmaceutical products. At the time of Cefepime Mixture With Arginine 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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