First Publication Date: 9th February 2010. In furtherance to Vikram’s post on Paragraph IV certification and its exploitation by generic pharmaceutical companies (ANDA applicant) to enter the market sooner, here is an insight on the NDA holders’ attempt to exploit the same. Every ANDA application filed by a generic company has to be in a prescribed format and must contain the prescribed content as per 21CFR sec. 314.94 (Contents and Format of an Abbreviated application). Each of these applications…