01 1China Chemical Industry Co., Ltd.
02 1Dipharma Francis S. r. l.
03 1Muromachi Chemical Co., Ltd.
04 1Shandong Keyuan Pharmaceutical Co. , Ltd.
01 170% isosorbide mononitrate lactose powder
02 1Isosorbide Mononitrate 70% / Lactose 30%
03 1Isosorbide mononitrate
04 1Japanese Pharmacopoeia drugs isosorbide dinitrate "(production only)."
01 1China
02 1Italy
03 2Japan
Japanese Pharmacopoeia Isosorbide Dinitrate (For manufacturing only)
Registration Number : 217MF10798
Registrant's Address : 1-6, Tenno Shioyacho, Kure City, Hiroshima Prefecture
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2007-01-24
Registration Number : 218MF10745
Registrant's Address : Via Bissone, 5, 20021-Baranzate, Milano, Italy
Initial Date of Registration : 2006-09-06
Latest Date of Registration : 2020-04-22
70% Isosorbide Mononitrate Lactose Powder
Registration Number : 225MF10192
Registrant's Address : 1-38-5 Shinshotachicho, Omuta City, Fukuoka Prefecture
Initial Date of Registration : 2013-10-09
Latest Date of Registration : 2013-10-09
Isosorbide Mononitrate 70%/Lactose 30%
Registration Number : 229MF10189
Registrant's Address : Keyuan Street, Shandong Shanghe Economic Development Zone, Jinan City, Shandong, Chin...
Initial Date of Registration : 2017-10-26
Latest Date of Registration : 2017-10-26
A Isosorbide Mononitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isosorbide Mononitrate, including repackagers and relabelers. The FDA regulates Isosorbide Mononitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isosorbide Mononitrate 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 Isosorbide Mononitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isosorbide Mononitrate supplier is an individual or a company that provides Isosorbide Mononitrate active pharmaceutical ingredient (API) or Isosorbide Mononitrate finished formulations upon request. The Isosorbide Mononitrate suppliers may include Isosorbide Mononitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Isosorbide Mononitrate 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 Isosorbide Mononitrate Drug Master File in Japan (Isosorbide Mononitrate JDMF) empowers Isosorbide Mononitrate 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 Isosorbide Mononitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Isosorbide Mononitrate 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 Isosorbide Mononitrate suppliers with JDMF on PharmaCompass.
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