01 1Mitsui Chemicals, Inc.
02 2Tateyama Chemical Co., Ltd.
01 2Nifekalant hydrochloride
02 1Shinbitto bulk powder
01 3Japan
Registration Number : 218MF10808
Registrant's Address : 1-5-2 Higashi-Shinbashi, Minato-ku, Tokyo
Initial Date of Registration : 2006-10-06
Latest Date of Registration : 2006-10-06
Registration Number : 227MF10006
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2015-01-05
Latest Date of Registration : 2015-01-05
Registration Number : 228MF10068
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2016-02-29
Latest Date of Registration : 2017-02-15
A Nifekalant Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nifekalant Hydrochloride, including repackagers and relabelers. The FDA regulates Nifekalant Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nifekalant 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.
A Nifekalant Hydrochloride supplier is an individual or a company that provides Nifekalant Hydrochloride active pharmaceutical ingredient (API) or Nifekalant Hydrochloride finished formulations upon request. The Nifekalant Hydrochloride suppliers may include Nifekalant Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Nifekalant 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 Nifekalant Hydrochloride Drug Master File in Japan (Nifekalant Hydrochloride JDMF) empowers Nifekalant 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 Nifekalant Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Nifekalant 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 Nifekalant Hydrochloride suppliers with JDMF on PharmaCompass.
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