01 1Patheon Austria GmbH & Co KG
01 1Neostigmine Bromide
01 1U.S.A
Registration Number : 306MF10020
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2024-01-30
Latest Date of Registration : 2024-01-30
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A 005SYP50G5 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 005SYP50G5, including repackagers and relabelers. The FDA regulates 005SYP50G5 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 005SYP50G5 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 005SYP50G5 supplier is an individual or a company that provides 005SYP50G5 active pharmaceutical ingredient (API) or 005SYP50G5 finished formulations upon request. The 005SYP50G5 suppliers may include 005SYP50G5 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 005SYP50G5 Drug Master File in Japan (005SYP50G5 JDMF) empowers 005SYP50G5 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 005SYP50G5 JDMF during the approval evaluation for pharmaceutical products. At the time of 005SYP50G5 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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