01 1SperaNexus Inc.
01 1Phenylephrine hydrochloride
01 1Japan
Registration Number : 217MF10030
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2007-04-27
A Phenylephrine.HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylephrine.HCl, including repackagers and relabelers. The FDA regulates Phenylephrine.HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylephrine.HCl 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 Phenylephrine.HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenylephrine.HCl supplier is an individual or a company that provides Phenylephrine.HCl active pharmaceutical ingredient (API) or Phenylephrine.HCl finished formulations upon request. The Phenylephrine.HCl suppliers may include Phenylephrine.HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Phenylephrine.HCl 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 Phenylephrine.HCl Drug Master File in Japan (Phenylephrine.HCl JDMF) empowers Phenylephrine.HCl 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 Phenylephrine.HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Phenylephrine.HCl 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 Phenylephrine.HCl suppliers with JDMF on PharmaCompass.
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