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multibillion dollar business tool. They have already launched FDC globally and among the
leading companies are Merck with 10, Novartis with 9, and GlaxoSmithKline with 8, Abbott
6, Pfizer 6, Bayer 5, Boehringer 5, AstraZeneca 4, BMS 4, Gilead 4, Takeda 4 FDC products
and others 66.
We should feel proud that we have immense number of FDC approval from CDSCO. Now
we should take process patent on priority. Pharmaceutical companies should innovate more
and more FDC. CDSCO generally give priority in approval for FDC those approved
anywhere in US or Europe. CDSCO should remove block barrier that even any FDC if not
approved in US or Europe can be approved first time in the world by CDSCO. Tapentadol &
paracetamol combination has been rejected whereas Tramadol & paracetamol is approved
with CDSCO. It is noteworthy tramdol is 100% opiod where as tapendaol is 50% opiod and
50% non-opiod. Tapentadol is safer than tramadol. Hence tapentadol & paracetamol is better
alternative and it should be approved in India.