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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
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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.
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01 3Diluted isosorbide dinitrate
02 4Isosorbide dinitrate
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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 ISD manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ISD, including repackagers and relabelers. The FDA regulates ISD manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ISD 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 ISD manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ISD supplier is an individual or a company that provides ISD active pharmaceutical ingredient (API) or ISD finished formulations upon request. The ISD suppliers may include ISD API manufacturers, exporters, distributors and traders.
click here to find a list of ISD 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 ISD Drug Master File in Korea (ISD KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ISD. The MFDS reviews the ISD KDMF as part of the drug registration process and uses the information provided in the ISD KDMF to evaluate the safety and efficacy of the drug.
After submitting a ISD 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 ISD API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ISD suppliers with KDMF on PharmaCompass.
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