01 1Kyongbo Pharmaceutical Co. , Ltd.
02 1Ohara Pharmaceutical Co., Ltd.
03 1Osaka Synthetic Organic Chemistry Research Institute Co., Ltd.
01 1Hydrochloric acid imidapril
02 1Imidapril hydrochloride
03 1Only the Japanese Pharmacopoeia imidapril hydrochloride salt production
01 2Japan
02 1South Korea
Registration Number : 227MF10222
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2015-08-31
Latest Date of Registration : 2015-08-31
Registration Number : 219MF10095
Registrant's Address : 121-15 Torii-no, Koka-cho, Koka City, Shiga Prefecture
Initial Date of Registration : 2007-03-14
Latest Date of Registration : 2007-03-14
Japanese Pharmacopoeia Imidapril Hydrochloride (For Manufacturing Use Only)
Registration Number : 221MF10285
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2009-12-22
Latest Date of Registration : 2020-12-07
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A Hormosan brand of imidapril hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hormosan brand of imidapril hydrochloride, including repackagers and relabelers. The FDA regulates Hormosan brand of imidapril hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hormosan brand of imidapril 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.
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A Hormosan brand of imidapril hydrochloride supplier is an individual or a company that provides Hormosan brand of imidapril hydrochloride active pharmaceutical ingredient (API) or Hormosan brand of imidapril hydrochloride finished formulations upon request. The Hormosan brand of imidapril hydrochloride suppliers may include Hormosan brand of imidapril hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Hormosan brand of imidapril hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Hormosan brand of imidapril hydrochloride Drug Master File in Japan (Hormosan brand of imidapril hydrochloride JDMF) empowers Hormosan brand of imidapril 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 Hormosan brand of imidapril hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Hormosan brand of imidapril hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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