01 1BIOFER SPA
01 1Sam-O Pharmaceutical Co., Ltd.
01 1Polymaltose ferric hydroxide complex
01 1Italy
Polymaltose ferric hydroxide complex
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2022-01-10
Registration Number : 20220110-211-J-1113
Manufacturer Name : BIOFER SPA
Manufacturer Address : Via Canina, 2 - 41036 MEDOLLA (MO), Italy
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A Intrafer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Intrafer, including repackagers and relabelers. The FDA regulates Intrafer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Intrafer API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Intrafer supplier is an individual or a company that provides Intrafer active pharmaceutical ingredient (API) or Intrafer finished formulations upon request. The Intrafer suppliers may include Intrafer API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Intrafer Drug Master File in Korea (Intrafer KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Intrafer. The MFDS reviews the Intrafer KDMF as part of the drug registration process and uses the information provided in the Intrafer KDMF to evaluate the safety and efficacy of the drug.
After submitting a Intrafer 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 Intrafer API can apply through the Korea Drug Master File (KDMF).
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