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 Laxine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Laxine, including repackagers and relabelers. The FDA regulates Laxine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Laxine 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 Laxine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Laxine supplier is an individual or a company that provides Laxine active pharmaceutical ingredient (API) or Laxine finished formulations upon request. The Laxine suppliers may include Laxine API manufacturers, exporters, distributors and traders.
click here to find a list of Laxine 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 Laxine Drug Master File in Japan (Laxine JDMF) empowers Laxine 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 Laxine JDMF during the approval evaluation for pharmaceutical products. At the time of Laxine 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 Laxine suppliers with JDMF on PharmaCompass.
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