01 1Estec Pharma Co., Ltd. @ [Product manufacturer] Yuil Pharmtech Co., Ltd.
01 1Polaris AI Pharma Co., Ltd.
01 1Droxidopa
01 1Japan
Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2018-08-14
Registration Number : 20180814-211-J-252
Manufacturer Name : Estec Pharma Co., Ltd. @ [Pr...
Manufacturer Address : 25, Balan Industrial Complex Road, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, 34 Block 1...
A Northera manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Northera, including repackagers and relabelers. The FDA regulates Northera manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Northera 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 Northera manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Northera supplier is an individual or a company that provides Northera active pharmaceutical ingredient (API) or Northera finished formulations upon request. The Northera suppliers may include Northera API manufacturers, exporters, distributors and traders.
click here to find a list of Northera 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 Northera Drug Master File in Korea (Northera KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Northera. The MFDS reviews the Northera KDMF as part of the drug registration process and uses the information provided in the Northera KDMF to evaluate the safety and efficacy of the drug.
After submitting a Northera 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 Northera API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Northera suppliers with KDMF on PharmaCompass.
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