Generic pharmaceutical manufacturer

An organization of the generic drug industiy in the US., representing generic pharmaceutical manufacturers, distributors and their suppliers. 

Case History Takeda, in an attempt to protect Actos from generic competition, sued various generic pharmaceutical manufacturers (collectively Alphapharm) for infringing the claims of U.S. Patent No. 4,687,777 ( 777). At trial, Alphapharm asserted that the compounds covered by the claims of the 777 patent were obvious in view of a prior art compound. The district court found the compounds covered by the claims of the 777... 

Infringement Exemptions for Generic Pharmaceutical Manufacturers under Hatch-Waxman Provisions... 

Wechsler J. The push for generics challenges manufacturers. Pharmaceutical Technology July 26-34 (2003). 

Pharmacokinetic studies are so important in the pharmaceutical arena, that they play the central role in FDA approval of generic versions of drugs. A generic drug manufacturer has to demonstrate to the FDA s satisfaction a capability to manufacture the drug with appropriate levels of quality. But beyond that, the generic manufacturer need... 

The key objective of this chapter is to describe a generic and systematic pharmaceutical manufacturing/assembly system design method that includes product, process, service systems, and even innovation project management architecture aspects of such systems. 

Our failure risk analysis and opportunity method and iterative software tool, as part of our New Product Process Innovation (NPPI) Tool Library, promotes systematic collaboration and team-oriented engineering thinking when a new pharmaceutical manufacturing system process and/or product are developed. (We call it opportunity method too, since most risks, if not all, offer new opportunities for innovation.) It is based on our generic process failure risk analysis method that could be apphed to literally any process that involves risk—and innovation is a very risky process. 

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