01 1Shandong Xinhua Pharmaceutical Co. , Ltd.
01 1Pipemidic acid hydrate
01 1China
Registration Number : 221MF10201
Registrant's Address : No. 14, Dongyi Road, Zhangdian Zibo, Shandong, P. R. China
Initial Date of Registration : 2009-09-14
Latest Date of Registration : 2009-09-14
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A 1-Pyridineacetic acid, hexahydro- manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-Pyridineacetic acid, hexahydro-, including repackagers and relabelers. The FDA regulates 1-Pyridineacetic acid, hexahydro- manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-Pyridineacetic acid, hexahydro- 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 1-Pyridineacetic acid, hexahydro- supplier is an individual or a company that provides 1-Pyridineacetic acid, hexahydro- active pharmaceutical ingredient (API) or 1-Pyridineacetic acid, hexahydro- finished formulations upon request. The 1-Pyridineacetic acid, hexahydro- suppliers may include 1-Pyridineacetic acid, hexahydro- 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 1-Pyridineacetic acid, hexahydro- Drug Master File in Japan (1-Pyridineacetic acid, hexahydro- JDMF) empowers 1-Pyridineacetic acid, hexahydro- 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 1-Pyridineacetic acid, hexahydro- JDMF during the approval evaluation for pharmaceutical products. At the time of 1-Pyridineacetic acid, hexahydro- 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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