01 1Quimica Syntetica S. A.
01 1Guanfacine hydrochloride
01 1Spain
Registration Number : 227MF10293
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2015-12-24
Latest Date of Registration : 2017-01-31
A Guanfacine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Guanfacine, including repackagers and relabelers. The FDA regulates Guanfacine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Guanfacine 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 Guanfacine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Guanfacine supplier is an individual or a company that provides Guanfacine active pharmaceutical ingredient (API) or Guanfacine finished formulations upon request. The Guanfacine suppliers may include Guanfacine API manufacturers, exporters, distributors and traders.
click here to find a list of Guanfacine 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 Guanfacine Drug Master File in Japan (Guanfacine JDMF) empowers Guanfacine 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 Guanfacine JDMF during the approval evaluation for pharmaceutical products. At the time of Guanfacine 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 Guanfacine suppliers with JDMF on PharmaCompass.
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