01 1Antibio(')ticos do Brazil Ltda
01 1Cephalothin sodium
01 1Brazil
Registration Number : 219MF10341
Registrant's Address : Rodovia Professor Zeferino Vaz,SP-332 Km 135 Cosmo(')polis-SP-Brazil ZpC 13151-350
Initial Date of Registration : 2007-11-21
Latest Date of Registration : 2020-06-11
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A Keflin N Injektionsflaschen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Keflin N Injektionsflaschen, including repackagers and relabelers. The FDA regulates Keflin N Injektionsflaschen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Keflin N Injektionsflaschen 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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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 Keflin N Injektionsflaschen Drug Master File in Japan (Keflin N Injektionsflaschen JDMF) empowers Keflin N Injektionsflaschen 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 Keflin N Injektionsflaschen JDMF during the approval evaluation for pharmaceutical products. At the time of Keflin N Injektionsflaschen 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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