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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PharmaCompass also assists you with knowing the Ipratropium Bromide API Price utilized in the formulation of products. Ipratropium Bromide API Price is not always fixed or binding as the Ipratropium Bromide Price is obtained through a variety of data sources. The Ipratropium Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ipratropium Bromide, (exo,syn)-Isomer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ipratropium Bromide, (exo,syn)-Isomer, including repackagers and relabelers. The FDA regulates Ipratropium Bromide, (exo,syn)-Isomer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer supplier is an individual or a company that provides Ipratropium Bromide, (exo,syn)-Isomer active pharmaceutical ingredient (API) or Ipratropium Bromide, (exo,syn)-Isomer finished formulations upon request. The Ipratropium Bromide, (exo,syn)-Isomer suppliers may include Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer Drug Master File in Japan (Ipratropium Bromide, (exo,syn)-Isomer JDMF) empowers Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer JDMF during the approval evaluation for pharmaceutical products. At the time of Ipratropium Bromide, (exo,syn)-Isomer 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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