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Biological drugs or biologics such as insulin, penicillin, blood and blood products, vaccines, derivatives of natural substances, and extracts of living cells are grown or cultured in separate batches. Just as with beer or wine, the quality can vary considerably by batch depending on small differences in inputs. Thus, in addition to obtaining marketing approval, a biologics manufacturer previously also had to have its production methods and facilities FDA licensed. Moreover, every batch of biologics had to be FDA tested. Recent advances in biotechnology, however, have diminished the variation and made production more like that of nonbiological or chemically synthesized drugs. In 1995, the FDA announced simplified rules on well-characterized biologics, dropping manufacturing-facility licensing and batch certification in such cases. Today many biologics are treated in the same fashion as nonbiological drugs. The FDA s rules on biologics were codified in the 1997 Modernization Act. – The acid addition salt of Udenafil in which Udenafil is bonded to an organic acid statistical significance.
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