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 ATEM manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ATEM, including repackagers and relabelers. The FDA regulates ATEM manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ATEM 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 ATEM manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ATEM supplier is an individual or a company that provides ATEM active pharmaceutical ingredient (API) or ATEM finished formulations upon request. The ATEM suppliers may include ATEM API manufacturers, exporters, distributors and traders.
click here to find a list of ATEM 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 ATEM Drug Master File in Japan (ATEM JDMF) empowers ATEM 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 ATEM JDMF during the approval evaluation for pharmaceutical products. At the time of ATEM 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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