01 1LUPIN LIMITED.
02 1Sanwa Chemical Co., Ltd.
03 1Themis Medicare Ltd.
01 2Ethambutol hydrochloride
02 1Japanese Pharmacopoeia hydrochloric acid ethambutol (production only)
01 2India
02 1Japan
Registration Number : 225MF10019
Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 4...
Initial Date of Registration : 2013-02-05
Latest Date of Registration : 2013-02-05
Japanese Pharmacopoeia Ethambutol Hydrochloride (for manufacturing only)
Registration Number : 218MF10556
Registrant's Address : 24-8 Tamura 9-chome, Hiratsuka City, Kanagawa Prefecture
Initial Date of Registration : 2006-06-02
Latest Date of Registration : 2009-03-16
Registration Number : 221MF10232
Registrant's Address : 11/12, Udyog Nagar, S. V. Road, Goregaon-West, Mumbai-400104, India
Initial Date of Registration : 2009-10-26
Latest Date of Registration : 2009-10-26
A Ethambutol Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethambutol Dihydrochloride, including repackagers and relabelers. The FDA regulates Ethambutol Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethambutol Dihydrochloride 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 Ethambutol Dihydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ethambutol Dihydrochloride supplier is an individual or a company that provides Ethambutol Dihydrochloride active pharmaceutical ingredient (API) or Ethambutol Dihydrochloride finished formulations upon request. The Ethambutol Dihydrochloride suppliers may include Ethambutol Dihydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ethambutol Dihydrochloride 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 Ethambutol Dihydrochloride Drug Master File in Japan (Ethambutol Dihydrochloride JDMF) empowers Ethambutol Dihydrochloride 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 Ethambutol Dihydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ethambutol Dihydrochloride 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 Ethambutol Dihydrochloride suppliers with JDMF on PharmaCompass.
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