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
A Ipratropium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ipratropium Bromide, including repackagers and relabelers. The FDA regulates Ipratropium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ipratropium Bromide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ipratropium Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ipratropium Bromide supplier is an individual or a company that provides Ipratropium Bromide active pharmaceutical ingredient (API) or Ipratropium Bromide finished formulations upon request. The Ipratropium Bromide suppliers may include Ipratropium Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Ipratropium Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 Drug Master File in Japan (Ipratropium Bromide JDMF) empowers Ipratropium Bromide 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Ipratropium Bromide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Ipratropium Bromide suppliers with JDMF on PharmaCompass.
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