01 1Alfasigma SpA/@OPOCRIN SpA_x000D_ @Sam-O Pharmaceutical Co., Ltd.
02 1Alfasigma SpA@ OPOCRIN SpA
03 1Biofer SpA
01 1Aju Pharmaceutical Co., Ltd.
02 1Pami Future Co., Ltd.
03 1Samoh Pharmaceutical Co., Ltd.
01 3Sulodexide
01 3Italy
Registrant Name : Aju Pharmaceutical Co., Ltd.
Registration Date : 2013-01-31
Registration Number : 20121026-149-I-108-01(1)
Manufacturer Name : Alfasigma SpA@ OPOCRIN SpA
Manufacturer Address : Via ENRICO FERMI 1-65020 ALANNO(PE), ITALY@Via Pacinotti, 3 41043 CORLO Di FORMIGINE ...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2012-10-26
Registration Number : 20121026-149-I-108-01
Manufacturer Name : Alfasigma SpA/@OPOCRIN SpA_x...
Manufacturer Address : Via Enrico Fermi 1-65020 Alanno (PE), Italy @ Via Pacinotti, 3 41043 CORLO Di FORMIGI...
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2019-11-25
Registration Number : 20191125-149-I-563-02
Manufacturer Name : Biofer SpA
Manufacturer Address : Via Canina, 2, 41036 MEDOLLA (MO), ITALY
A Sulodexide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulodexide, including repackagers and relabelers. The FDA regulates Sulodexide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulodexide 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 Sulodexide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulodexide supplier is an individual or a company that provides Sulodexide active pharmaceutical ingredient (API) or Sulodexide finished formulations upon request. The Sulodexide suppliers may include Sulodexide API manufacturers, exporters, distributors and traders.
click here to find a list of Sulodexide 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 Sulodexide Drug Master File in Korea (Sulodexide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sulodexide. The MFDS reviews the Sulodexide KDMF as part of the drug registration process and uses the information provided in the Sulodexide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sulodexide 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 Sulodexide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sulodexide suppliers with KDMF on PharmaCompass.
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