01 3China Chemical Industry Co., Ltd.
02 1DOTTIKON EXCLUSIVE SYNTHESIS AG
03 1Muromachi Chemical Co., Ltd.
01 1Isosorbide dinitrate 20% solution
02 1Isosorbide dinitrate 20% solution Chuka
03 1Isosorbide dinitrate 25% Chichuka
04 1Isosorbide dinitrate 40% Chichuka
05 1Nitrate isosorbitol 40% powder P1007.021
01 4Japan
02 1Switzerland
Isosorbide dinitrate 25% in powder form
Registration Number : 217MF10796
Registrant's Address : 1-6, Tenno Shioyacho, Kure City, Hiroshima Prefecture
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2007-04-27
Isosorbide dinitrate 20% solution
Registration Number : 217MF10797
Registrant's Address : 1-6, Tenno Shioyacho, Kure City, Hiroshima Prefecture
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2009-06-16
Isosorbide dinitrate 40% dispersion
Registration Number : 217MF10795
Registrant's Address : 1-6, Tenno Shioyacho, Kure City, Hiroshima Prefecture
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2006-05-18
Isosorbitol nitrate 40% powder P1007.021
Registration Number : 217MF11278
Registrant's Address : Hembrunnstr. 17, CH-5605 Dottikon, Switzerland
Initial Date of Registration : 2005-12-20
Latest Date of Registration : 2008-03-28
Isosorbide dinitrate 20% solution
Registration Number : 217MF10572
Registrant's Address : 1-38-5 Shinshotachicho, Omuta City, Fukuoka Prefecture
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2009-06-02
A Isosorbide Dinitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isosorbide Dinitrate, including repackagers and relabelers. The FDA regulates Isosorbide Dinitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isosorbide Dinitrate 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 Dinitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isosorbide Dinitrate supplier is an individual or a company that provides Isosorbide Dinitrate active pharmaceutical ingredient (API) or Isosorbide Dinitrate finished formulations upon request. The Isosorbide Dinitrate suppliers may include Isosorbide Dinitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Isosorbide Dinitrate 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 Dinitrate Drug Master File in Japan (Isosorbide Dinitrate JDMF) empowers Isosorbide Dinitrate 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 Dinitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Isosorbide Dinitrate 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 Dinitrate suppliers with JDMF on PharmaCompass.
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