01 1Alps Pharmaceutical Co., Ltd.
01 1Japanese Pharmacopoeia funnel extract
01 1Japan
Japanese Pharmacopoeia Scopolia Extract
Registration Number : 217MF11030
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2005-12-02
Latest Date of Registration : 2010-04-01
A Hyoscyamine Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyoscyamine Sulfate, including repackagers and relabelers. The FDA regulates Hyoscyamine Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyoscyamine Sulfate 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 Hyoscyamine Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyoscyamine Sulfate supplier is an individual or a company that provides Hyoscyamine Sulfate active pharmaceutical ingredient (API) or Hyoscyamine Sulfate finished formulations upon request. The Hyoscyamine Sulfate suppliers may include Hyoscyamine Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Hyoscyamine Sulfate 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 Hyoscyamine Sulfate Drug Master File in Japan (Hyoscyamine Sulfate JDMF) empowers Hyoscyamine Sulfate 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 Hyoscyamine Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Hyoscyamine Sulfate 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 Hyoscyamine Sulfate suppliers with JDMF on PharmaCompass.
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