EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registration Number : 218MF10733
Registrant's Address : 37 Hollands Road, Haverhill, Suffolk CB9 8PU, U.S. K.
Initial Date of Registration : 2006-09-06
Latest Date of Registration : 2011-04-12
A Sevelamer Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sevelamer Hydrochloride, including repackagers and relabelers. The FDA regulates Sevelamer Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sevelamer 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 Sevelamer Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sevelamer Hydrochloride supplier is an individual or a company that provides Sevelamer Hydrochloride active pharmaceutical ingredient (API) or Sevelamer Hydrochloride finished formulations upon request. The Sevelamer Hydrochloride suppliers may include Sevelamer Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sevelamer 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 Sevelamer Hydrochloride Drug Master File in Japan (Sevelamer Hydrochloride JDMF) empowers Sevelamer 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 Sevelamer Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Sevelamer 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 Sevelamer Hydrochloride suppliers with JDMF on PharmaCompass.
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