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Factors driving the growth of FDCs One of the primary reasons for the rise of FDCs has been their role in addressing diseases that require multi-drug therapy, such as tuberculosis, cardiovascular conditions, diabetes, and infectious diseases. Rifampicin + Isoniazid + Ethambutol) Antimalarial combinations (e.g.,
According to the World Health Organisation (WHO), an estimated two billion people across the world do not have access to essential medicines for life threatening diseases like cancer, AIDS and even autoimmune diseases like Type 1 diabetes.
The FDA’s 505(b)(2) pathway and the European Medicines Agency’s (EMA) Hybrid Pathway offer routes for drug developers to rely on previously submitted clinical data, cutting down approval times significantly. As the world’s largest manufacturer of genericmedicines, India has vast potential to utilise repurposed drugs.
Since manufacturers know the precise quality specifications, standards help make the approval process for genericmedicines more efficient. Starting in 2018, the presence of nitrosamine impurities was identified in some angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure.
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