01 2CHANGZHOU YABANG PHARMACEUTICAL CO. , LTD.
02 2Sanyo Chemical Research Institute Co., Ltd.
03 1SperaNexus Inc.
01 2MEXILETINE HYDROCHLORIDE
02 3Mexiletine hydrochloride
01 2China
02 2Gabon
03 1Japan
Registration Number : 230MF10140
Registrant's Address : Liangchang East Road 6#, Jintan, Jiangsu Province, P. R. China
Initial Date of Registration : 2018-10-12
Latest Date of Registration : 2018-10-12
Registration Number : 220MF10055
Registrant's Address : Liangchang East Road 6#, Jintan, Jiangsu Province, P. R. China
Initial Date of Registration : 2008-02-08
Latest Date of Registration : 2010-07-26
Registration Number : 217MF10039
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2010-02-09
Registration Number : 301MF10087
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2019-11-11
Latest Date of Registration : 2019-11-11
Registration Number : 219MF10182
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2007-06-01
Latest Date of Registration : 2007-06-01
A Mexiletine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mexiletine, including repackagers and relabelers. The FDA regulates Mexiletine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mexiletine 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 Mexiletine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mexiletine supplier is an individual or a company that provides Mexiletine active pharmaceutical ingredient (API) or Mexiletine finished formulations upon request. The Mexiletine suppliers may include Mexiletine API manufacturers, exporters, distributors and traders.
click here to find a list of Mexiletine 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 Mexiletine Drug Master File in Japan (Mexiletine JDMF) empowers Mexiletine 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 Mexiletine JDMF during the approval evaluation for pharmaceutical products. At the time of Mexiletine 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 Mexiletine suppliers with JDMF on PharmaCompass.
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