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With more than US$200 Billion
worth sales drugs going off patent in near future, the Generic
Drug Industry provides a significant opportunity for GMP
compliant cost effective manufacturers. In addition, with 95% of
the Healthcare spending concentrated in USA, Europe & Japan, the
Regulated markets does provide a formidable business opportunity
for Generic Drug Manufacturers.
The ANDA factory model therefore
re-defines the corporate focus temporarily from a manufacturing
centric model to ANDA process centric model. From this
perspective, ThinkGen is helping create a consortium of
leading Generic Drug manufacturers who would rapidly file ANDA/CTD
applications in quick succession into the regulated markets.
ThinkGen through its
international network is also in the advanced stage of evolving
strategic partnership with leading US and European
Pharmaceutical / Biotech and Group Purchase Organizations (GPO).
ANDA factory organizes the
processes in a typical pharma / Biotech Company in such a way
that Regulatory and related processes get CORE process focus.
The Repository of Standard Operating Procedures coupled with a
punch list, can help these organizations become compliant to a
Global Regulatory framework. The ADAPT process model which
provides for such a framework closely couples with the
Bio-Informatics Hubs, thereby providing the Generic Drug
Companies to leverage a viable revenue model to graduate to the
IPR bandwagon.
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