01 1Hanseochem@Jingjing Pharmaceutical Co., Ltd.
02 1Samhwa Biopharm Co., Ltd.
01 1Hanseochem Co., Ltd.
02 1Samhwa Biopharm Co., Ltd.
01 2L-Aspartic Acid-L-Ornithine
01 2South Korea
Registrant Name : Hanseochem Co., Ltd.
Registration Date : 2023-01-12
Registration Number : 20230112-211-J-1435
Manufacturer Name : Hanseochem@Jingjing Pharmace...
Manufacturer Address : 41, Poseung Industrial Complex Road, Poseung-eup, Pyeongtaek-si, Gyeonggi-do @No. 88,...
Registrant Name : Samhwa Biopharm Co., Ltd.
Registration Date : 2022-11-16
Registration Number : 20221116-211-J-1404
Manufacturer Name : Samhwa Biopharm Co., Ltd.
Manufacturer Address : 150 Hyeop-ro, Siheung-si, Gyeonggi-do
A L- Aspartic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L- Aspartic acid, including repackagers and relabelers. The FDA regulates L- Aspartic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L- Aspartic acid 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 L- Aspartic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L- Aspartic acid supplier is an individual or a company that provides L- Aspartic acid active pharmaceutical ingredient (API) or L- Aspartic acid finished formulations upon request. The L- Aspartic acid suppliers may include L- Aspartic acid API manufacturers, exporters, distributors and traders.
click here to find a list of L- Aspartic acid 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 L- Aspartic acid Drug Master File in Korea (L- Aspartic acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of L- Aspartic acid. The MFDS reviews the L- Aspartic acid KDMF as part of the drug registration process and uses the information provided in the L- Aspartic acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a L- Aspartic acid 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 L- Aspartic acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of L- Aspartic acid suppliers with KDMF on PharmaCompass.
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