01 2Albumedix Limited
01 1Recombumin Elite
02 1Recombumin Prime
01 2United Kingdom
Registration Number : 303MF20002
Registrant's Address : Mabel Street, The Meadows, Nottingham, NG2 3ED, United Kingdom
Initial Date of Registration : 2021-03-11
Latest Date of Registration : 2021-03-11
Registration Number : 303MF20001
Registrant's Address : Mabel Street, The Meadows, Nottingham, NG2 3ED, United Kingdom
Initial Date of Registration : 2021-03-05
Latest Date of Registration : 2021-03-05
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Perflutren Drug Master File in Japan (Perflutren JDMF) empowers Perflutren API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Perflutren JDMF during the approval evaluation for pharmaceutical products. At the time of Perflutren JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Perflutren suppliers with JDMF on PharmaCompass.
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