Refine by
Drug Application Articles & Analysis: This-Year
4 news found
Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical companies. ...
(Huateng Pharma), a global leader in the development and production of high-quality PEG derivatives, is pleased to announce that its mPEG-pALD (20K) has successfully completed its Drug Master File (DMF) filing with the U.S. Food and Drug Administration (FDA), under DMF No. 040600. ...
An Abbreviated New Drug Application (ANDA) is an application submitted to the U.S. FDA to demonstrate that a generic drug is equivalent to a previously approved Reference Listed Drug (RLD) in terms of safety, efficacy, and quality. ...
Biopharma PEG, a leading manufacturer of high-quality polyethylene glycol (PEG) derivatives, today announced that its mPEG-pAld (20K) product has successfully achieved DMF (Drug Master File) registration with the U.S. Food and Drug Administration (FDA) under DMF number 040600. ...