01 1Boehringer Ingelheim Pharma GmbH & Co. K.G.
01 1Ipratropium bromide hydrate
01 1Germany
Registration Number : 220MF10081
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2008-03-14
Latest Date of Registration : 2023-11-08
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A COMBIVENT-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of COMBIVENT-1, including repackagers and relabelers. The FDA regulates COMBIVENT-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. COMBIVENT-1 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 COMBIVENT-1 supplier is an individual or a company that provides COMBIVENT-1 active pharmaceutical ingredient (API) or COMBIVENT-1 finished formulations upon request. The COMBIVENT-1 suppliers may include COMBIVENT-1 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 COMBIVENT-1 Drug Master File in Japan (COMBIVENT-1 JDMF) empowers COMBIVENT-1 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 COMBIVENT-1 JDMF during the approval evaluation for pharmaceutical products. At the time of COMBIVENT-1 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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