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01 1Fermion Oy
02 1Jiangsu Hengrui Pharmaceuticals Co. , Ltd.
03 2Joint Stock Company Grindeks
04 1Tateyama Chemical Co., Ltd.
01 1Dexmedetomidine Hydrochloide
02 1Dexmedetomidine Hydrochloride
03 1Dexmedetomidine hydrochloride "Tateyama"
04 1Hydrochloric acid dexmedetomidine
05 1Hydrochloric acid dexmedetomidine (production only)
01 1China
02 1Finland
03 1Japan
04 2Latvia
Dexmedetomidine hydrochloride (for manufacturing only)
Registration Number : 218MF10833
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2006-10-20
Latest Date of Registration : 2021-07-01
Registration Number : 303MF10179
Registrant's Address : 53 Krustpils Street, Riga, Latvia
Initial Date of Registration : 2021-12-15
Latest Date of Registration : 2021-12-15
Registration Number : 228MF10234
Registrant's Address : 53 Krustpils Street, Riga, Latvia
Initial Date of Registration : 2016-12-26
Latest Date of Registration : 2016-12-26
Dexmedetomidine Hydrochloride “Hengrui”
Registration Number : 228MF10029
Registrant's Address : No. 7, Kunlunshan Road, Economic and Technological Development Zone, Lianyungang, Jia...
Initial Date of Registration : 2016-02-02
Latest Date of Registration : 2022-07-06
Dexmedetomidine hydrochloride "Tateyama"
Registration Number : 229MF10055
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2017-02-28
Latest Date of Registration : 2017-02-28
A Dexmedetomidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexmedetomidine, including repackagers and relabelers. The FDA regulates Dexmedetomidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexmedetomidine 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 Dexmedetomidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexmedetomidine supplier is an individual or a company that provides Dexmedetomidine active pharmaceutical ingredient (API) or Dexmedetomidine finished formulations upon request. The Dexmedetomidine suppliers may include Dexmedetomidine API manufacturers, exporters, distributors and traders.
click here to find a list of Dexmedetomidine 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 Dexmedetomidine Drug Master File in Japan (Dexmedetomidine JDMF) empowers Dexmedetomidine 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 Dexmedetomidine JDMF during the approval evaluation for pharmaceutical products. At the time of Dexmedetomidine 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 Dexmedetomidine suppliers with JDMF on PharmaCompass.
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