01 1FluoroMed LP
01 1Bukyeong SM Co., Ltd.
01 1Perfluthrene
01 1U.S.A
Registrant Name : Bukyeong SM Co., Ltd.
Registration Date : 2006-12-28
Registration Number : Su372-1-ND
Manufacturer Name : FluoroMed LP
Manufacturer Address : 2350 DOUBLE Creek Drive Round Rock, TX 78664
A Perflutren manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perflutren, including repackagers and relabelers. The FDA regulates Perflutren manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perflutren 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 Perflutren manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Perflutren supplier is an individual or a company that provides Perflutren active pharmaceutical ingredient (API) or Perflutren finished formulations upon request. The Perflutren suppliers may include Perflutren API manufacturers, exporters, distributors and traders.
click here to find a list of Perflutren 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 Perflutren Drug Master File in Korea (Perflutren KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Perflutren. The MFDS reviews the Perflutren KDMF as part of the drug registration process and uses the information provided in the Perflutren KDMF to evaluate the safety and efficacy of the drug.
After submitting a Perflutren 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 Perflutren API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Perflutren suppliers with KDMF on PharmaCompass.
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