01 1Alps Pharmaceutical Co., Ltd.
01 1Scopolamine hydrobromide hydrate
01 1Japan
Scopolamine hydrobromide hydrate
Registration Number : 303MF10050
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2021-03-22
Latest Date of Registration : 2021-03-22
A Scopolamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Scopolamine, including repackagers and relabelers. The FDA regulates Scopolamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Scopolamine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Scopolamine supplier is an individual or a company that provides Scopolamine active pharmaceutical ingredient (API) or Scopolamine finished formulations upon request. The Scopolamine suppliers may include Scopolamine API manufacturers, exporters, distributors and traders.
click here to find a list of Scopolamine 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 Drug Master File in Japan (Scopolamine JDMF) empowers Scopolamine 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Scopolamine 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 suppliers with JDMF on PharmaCompass.
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