01 1ESTECHPHARMA CO. , LTD.
02 1Ouchi Shinko Chemical Industry Co., Ltd.
01 1Bunazosin hydrochloride
02 1Japanese Pharmacopoeia bunazosin hydrochloride (production only)
01 1Japan
02 1South Korea
Registration Number : 223MF10013
Registrant's Address : 34BL/10,11, Baran Regional Industrial Complex, 1407-9, Hagil-ri, Hyangnam-eup, Hwaseo...
Initial Date of Registration : 2011-01-21
Latest Date of Registration : 2011-01-21
Japanese Pharmacopoeia Bunazosin Hydrochloride (for manufacturing only)
Registration Number : 225MF10068
Registrant's Address : 7-4, Nihonbashi Kofunecho, Chuo-ku, Tokyo
Initial Date of Registration : 2013-04-18
Latest Date of Registration : 2013-04-18
A Bunazosin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bunazosin Hydrochloride, including repackagers and relabelers. The FDA regulates Bunazosin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bunazosin 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 Bunazosin Hydrochloride supplier is an individual or a company that provides Bunazosin Hydrochloride active pharmaceutical ingredient (API) or Bunazosin Hydrochloride finished formulations upon request. The Bunazosin Hydrochloride suppliers may include Bunazosin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Bunazosin 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 Bunazosin Hydrochloride Drug Master File in Japan (Bunazosin Hydrochloride JDMF) empowers Bunazosin 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 Bunazosin Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Bunazosin 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 Bunazosin Hydrochloride suppliers with JDMF on PharmaCompass.
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