01 1Speranexus Co., Ltd.
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
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PharmaCompass offers a list of Phenylephrine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Phenylephrine Hydrochloride manufacturer or Phenylephrine Hydrochloride supplier for your needs.
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A Phenylephrine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylephrine Hydrochloride, including repackagers and relabelers. The FDA regulates Phenylephrine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylephrine 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 Phenylephrine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Phenylephrine Hydrochloride supplier is an individual or a company that provides Phenylephrine Hydrochloride active pharmaceutical ingredient (API) or Phenylephrine Hydrochloride finished formulations upon request. The Phenylephrine Hydrochloride suppliers may include Phenylephrine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Phenylephrine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Hydrochloride Drug Master File in Japan (Phenylephrine Hydrochloride JDMF) empowers Phenylephrine 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 Phenylephrine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Phenylephrine 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 Phenylephrine Hydrochloride suppliers with JDMF on PharmaCompass.
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