01 3Solara Active Pharma Sciences Limited
02 1Vifor(International) AG
01 1Aging Life Science Co., Ltd.
02 1Fresenius Medical Care Korea Co., Ltd.
03 1Lihu Healthcare Co., Ltd.
04 1Masung LS Co., Ltd.
01 4sucroferric oxyhydroxide
01 3India
02 1Switzerland
Registrant Name : Fresenius Medical Care Korea Co., Ltd.
Registration Date : 2018-03-19
Registration Number : Su539-1-ND
Manufacturer Name : Vifor(International) AG
Manufacturer Address : Rechenstrasse 37, 9014 St. Gallen, Switzerland
Registrant Name : Lihu Healthcare Co., Ltd.
Registration Date : 2024-07-25
Registration Number : No. 163-34-ND(B)
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A1/B, Sipcot Industrial Complex, Kudikadu, Cuddalore 607 005, India
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2024-05-31
Registration Number : No. 163-34-ND(A)
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A1/B, Sipcot Industrial Complex, Kudikadu, Cuddalore 607 005, India
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2024-04-30
Registration Number : 163-34-ND
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A1/B, SIPCOT Industrial Complex, Kudikadu,Cuddalore- 607 005, Tamil Nadu, India
A Iron Sucrose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iron Sucrose, including repackagers and relabelers. The FDA regulates Iron Sucrose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iron Sucrose 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 Iron Sucrose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iron Sucrose supplier is an individual or a company that provides Iron Sucrose active pharmaceutical ingredient (API) or Iron Sucrose finished formulations upon request. The Iron Sucrose suppliers may include Iron Sucrose API manufacturers, exporters, distributors and traders.
click here to find a list of Iron Sucrose 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 Iron Sucrose Drug Master File in Korea (Iron Sucrose KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Iron Sucrose. The MFDS reviews the Iron Sucrose KDMF as part of the drug registration process and uses the information provided in the Iron Sucrose KDMF to evaluate the safety and efficacy of the drug.
After submitting a Iron Sucrose 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 Iron Sucrose API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Iron Sucrose suppliers with KDMF on PharmaCompass.
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