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
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PharmaCompass offers a list of Isosorbide Mononitrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Isosorbide Mononitrate manufacturer or Isosorbide Mononitrate supplier for your needs.
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PharmaCompass also assists you with knowing the Isosorbide Mononitrate API Price utilized in the formulation of products. Isosorbide Mononitrate API Price is not always fixed or binding as the Isosorbide Mononitrate Price is obtained through a variety of data sources. The Isosorbide Mononitrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Uniket manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Uniket, including repackagers and relabelers. The FDA regulates Uniket manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Uniket 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 Uniket supplier is an individual or a company that provides Uniket active pharmaceutical ingredient (API) or Uniket finished formulations upon request. The Uniket suppliers may include Uniket API manufacturers, exporters, distributors and traders.
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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 Uniket Drug Master File in Japan (Uniket JDMF) empowers Uniket 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 Uniket JDMF during the approval evaluation for pharmaceutical products. At the time of Uniket 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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