01 1Cambrex Profarmaco Milano S. r. l.
02 1Shizuoka Caffeine Industry Co., Ltd.
01 1Bisacodyl
02 1Japanese Pharmacopoeia bisacodyl (production only)
01 1Japan
02 1U.S.A
Registration Number : 218MF10142
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2006-01-31
Latest Date of Registration : 2015-08-18
Japanese Pharmacopoeia Bisacodyl (for manufacturing only)
Registration Number : 217MF10614
Registrant's Address : 129 Suidocho, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2008-02-25
A Bisacodyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bisacodyl, including repackagers and relabelers. The FDA regulates Bisacodyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bisacodyl 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 Bisacodyl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bisacodyl supplier is an individual or a company that provides Bisacodyl active pharmaceutical ingredient (API) or Bisacodyl finished formulations upon request. The Bisacodyl suppliers may include Bisacodyl API manufacturers, exporters, distributors and traders.
click here to find a list of Bisacodyl 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 Bisacodyl Drug Master File in Japan (Bisacodyl JDMF) empowers Bisacodyl 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 Bisacodyl JDMF during the approval evaluation for pharmaceutical products. At the time of Bisacodyl 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 Bisacodyl suppliers with JDMF on PharmaCompass.
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