01 1Airgas Therapeutics, LLC
01 1Braco Imaging Korea Ltd.
01 1Sulphahexafluoride
01 1U.S.A
Registrant Name : Braco Imaging Korea Ltd.
Registration Date : 2005-06-14
Registration Number : Number 267-1-ND
Manufacturer Name : Airgas Therapeutics, LLC
Manufacturer Address : 6141 Easton Road-Building 3, Plumsteadville, PA 18949-0310
A Lumason manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lumason, including repackagers and relabelers. The FDA regulates Lumason manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lumason API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lumason supplier is an individual or a company that provides Lumason active pharmaceutical ingredient (API) or Lumason finished formulations upon request. The Lumason suppliers may include Lumason API manufacturers, exporters, distributors and traders.
click here to find a list of Lumason 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 Lumason Drug Master File in Korea (Lumason KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lumason. The MFDS reviews the Lumason KDMF as part of the drug registration process and uses the information provided in the Lumason KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lumason 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 Lumason API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lumason suppliers with KDMF on PharmaCompass.
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