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