01 1DIPHARMA FRANCIS srl
02 2Dipharma Francis Srl
03 1Dipharma Francis Srl@Adare Pharmaceuticals srl
04 2Dottikon Exclusive Synthesis AG
05 1JP Laboratories Private Limited
01 1Bukwang Pharmaceutical Co., Ltd.
02 2Erison Pharmaceutical Co., Ltd.
03 1KR Pharm Co., Ltd.
04 1Kolon Pharmaceutical Co., Ltd.
05 1Korea Unipharm Co., Ltd.
06 1Samoh Pharmaceutical Co., Ltd.
01 3Diluted isosorbide dinitrate
02 4Isosorbide dinitrate
01 1India
02 4Italy
03 2Switzerland
Registrant Name : Erison Pharmaceutical Co., Ltd.
Registration Date : 2022-12-14
Registration Number : 20221214-209-J-1421
Manufacturer Name : DIPHARMA FRANCIS srl
Manufacturer Address : Via XXIV Maggio 40, 33036 Mereto di Tomba (UD) Italy
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2021-12-07
Registration Number : 20211207-209-J-1172
Manufacturer Name : Dipharma Francis Srl@Adare P...
Manufacturer Address : 33036, Via XXIV Maggio, 40, Mereto di Tomba (UD), Italy@Via Martin Luther King, 13 20...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-08-25
Registration Number : 20220825-209-J-1350
Manufacturer Name : Dipharma Francis Srl
Manufacturer Address : Via XXIV Maggio 40-33036 Mereto di Tomba (UD) Italy
Registrant Name : Erison Pharmaceutical Co., Ltd.
Registration Date : 2023-01-06
Registration Number : 20220825-209-J-1350(1)
Manufacturer Name : Dipharma Francis Srl
Manufacturer Address : Via XXIV Maggio 40-33036 Mereto di Tomba (UD) Italy
Registrant Name : Korea Unipharm Co., Ltd.
Registration Date : 2020-08-28
Registration Number : 20200828-209-J-668
Manufacturer Name : Dottikon Exclusive Synthesis...
Manufacturer Address : Hembrunnstrasse 17 5605 Dottikon Switzerland
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20200828-209-J-668(1)
Manufacturer Name : Dottikon Exclusive Synthesis...
Manufacturer Address : Hembrunnstrasse 17 CH-5605 Dottikon Switzerland
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2022-09-28
Registration Number : 20220928-209-J-1370
Manufacturer Name : JP Laboratories Private Limi...
Manufacturer Address : Block A-76, MIDC Chemical Zone, Kurkumbh, Daund, Pune - 413 801 INDIA
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Isosorbide Dinitrate Drug Master File in Korea (Isosorbide Dinitrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isosorbide Dinitrate. The MFDS reviews the Isosorbide Dinitrate KDMF as part of the drug registration process and uses the information provided in the Isosorbide Dinitrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Isosorbide Dinitrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Isosorbide Dinitrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Isosorbide Dinitrate suppliers with KDMF on PharmaCompass.
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