01 1Hanmi Fine Chemical Co., Ltd.
01 1Hanmi Fine Chemical Co., Ltd.
01 1esomeprazole strontium tetrahydrate
01 1South Korea
esomeprazole strontium tetrahydrate
Registrant Name : Hanmi Fine Chemical Co., Ltd.
Registration Date : 2010-12-30
Registration Number : 20101230-127-H-115-02
Manufacturer Name : Hanmi Fine Chemical Co., Ltd...
Manufacturer Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do
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A Esomeprazole Strontium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole Strontium, including repackagers and relabelers. The FDA regulates Esomeprazole Strontium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole Strontium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Esomeprazole Strontium supplier is an individual or a company that provides Esomeprazole Strontium active pharmaceutical ingredient (API) or Esomeprazole Strontium finished formulations upon request. The Esomeprazole Strontium suppliers may include Esomeprazole Strontium API manufacturers, exporters, distributors and traders.
click here to find a list of Esomeprazole Strontium 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 Esomeprazole Strontium Drug Master File in Korea (Esomeprazole Strontium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Esomeprazole Strontium. The MFDS reviews the Esomeprazole Strontium KDMF as part of the drug registration process and uses the information provided in the Esomeprazole Strontium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Esomeprazole Strontium 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 Esomeprazole Strontium API can apply through the Korea Drug Master File (KDMF).
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