01 1Dipharma Francis Srl
02 1JP Laboratories Private Limited
03 3Shandong Keyuan Pharmaceutical Co., Ltd.
01 1Hyundai Pharmaceutical Co., Ltd.
02 1KR Pharm Co., Ltd.
03 1Samoh Pharmaceutical Co., Ltd.
04 2Wooshin Labotech Co., Ltd.
01 4Diluted isosorbide mononitrate
02 1Isosorbide-5-mononitrate 90%
01 3China
02 1India
03 1Italy
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-05-04
Registration Number : 20220504-209-J-1260
Manufacturer Name : Dipharma Francis Srl
Manufacturer Address : Via XXIV Maggio 40-33036 Mereto di Tomba (UD) Italy
Diluted isosorbide mononitrate
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2021-11-29
Registration Number : 20211129-209-J-654
Manufacturer Name : JP Laboratories Private Limi...
Manufacturer Address : Block A-76, MIDC Chemical Zone, Kurkumbh, Daund, Pune - 413 801 INDIA
Diluted isosorbide mononitrate
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2022-04-05
Registration Number : 20220324-209-J-1239(1)
Manufacturer Name : Shandong Keyuan Pharmaceutic...
Manufacturer Address : Keyuan Street, Shandong Shanghe Economic Development Zone, Jinan, Shandong, China
Diluted isosorbide mononitrate
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2022-03-24
Registration Number : 20220324-209-J-1239
Manufacturer Name : Shandong Keyuan Pharmaceutic...
Manufacturer Address : Keyuan Street, Shandong Shanghe Economic Development Zone, Jinan, Shandong, China
Diluted isosorbide mononitrate
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-209-J-775
Manufacturer Name : Shandong Keyuan Pharmaceutic...
Manufacturer Address : Keyuan Street, Shandong Shanghe Economic Development Zone, Junan City, Shandong, Chin...
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Isosorbide Mononitrate Drug Master File in Korea (Isosorbide Mononitrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isosorbide Mononitrate. The MFDS reviews the Isosorbide Mononitrate KDMF as part of the drug registration process and uses the information provided in the Isosorbide Mononitrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Isosorbide Mononitrate 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 Mononitrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Isosorbide Mononitrate suppliers with KDMF on PharmaCompass.
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