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