01 1Alps Pharmaceutical Co., Ltd.
02 1Boehringer Ingelheim Pharma GmbH & Co. K.G.
01 1Japanese Pharmacopoeia scopolamine hydrobromide hydrate
02 1Scopolamine hydrobromide hydrate
01 1Germany
02 1Japan
Japanese Pharmacopoeia Scopolamine Hydrobromide Hydrate
Registration Number : 227MF10032
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2015-01-23
Latest Date of Registration : 2015-01-23
Scopolamine hydrobromide hydrate
Registration Number : 221MF10105
Registrant's Address : Binger Strasse 173, 55216 Ingelheim am Rhein
Initial Date of Registration : 2009-05-27
Latest Date of Registration : 2009-05-27
A Scopolamine Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Scopolamine Hydrobromide, including repackagers and relabelers. The FDA regulates Scopolamine Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Scopolamine Hydrobromide 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 Scopolamine Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Scopolamine Hydrobromide supplier is an individual or a company that provides Scopolamine Hydrobromide active pharmaceutical ingredient (API) or Scopolamine Hydrobromide finished formulations upon request. The Scopolamine Hydrobromide suppliers may include Scopolamine Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Scopolamine Hydrobromide 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 Scopolamine Hydrobromide Drug Master File in Japan (Scopolamine Hydrobromide JDMF) empowers Scopolamine Hydrobromide 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 Scopolamine Hydrobromide JDMF during the approval evaluation for pharmaceutical products. At the time of Scopolamine Hydrobromide 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 Scopolamine Hydrobromide suppliers with JDMF on PharmaCompass.
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