01 1Jinan Yuteng Pharma Co., Ltd.
01 1Essel Bio Co., Ltd.
01 1isosorbide
01 1Blank
Registrant Name : Essel Bio Co., Ltd.
Registration Date : 2025-03-07
Registration Number : 20250307-209-J-1680
Manufacturer Name : Jinan Yuteng Pharma Co., Ltd...
Manufacturer Address : Sunguanzhuang Industrial Park, Yushan Street, Pingyin County, Jinan City, Shandong Pr...
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PharmaCompass offers a list of Isosorbide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Isosorbide manufacturer or Isosorbide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isosorbide manufacturer or Isosorbide supplier.
A ISMOTIC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ISMOTIC, including repackagers and relabelers. The FDA regulates ISMOTIC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ISMOTIC 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 ISMOTIC manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ISMOTIC supplier is an individual or a company that provides ISMOTIC active pharmaceutical ingredient (API) or ISMOTIC finished formulations upon request. The ISMOTIC suppliers may include ISMOTIC API manufacturers, exporters, distributors and traders.
click here to find a list of ISMOTIC suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 ISMOTIC Drug Master File in Korea (ISMOTIC KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ISMOTIC. The MFDS reviews the ISMOTIC KDMF as part of the drug registration process and uses the information provided in the ISMOTIC KDMF to evaluate the safety and efficacy of the drug.
After submitting a ISMOTIC 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 ISMOTIC API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ISMOTIC suppliers with KDMF on PharmaCompass.
