Last Updated on December 23, 2020 by The Health Master
As per the ratings agency, these companies have garnered 45% of all new Abbreviated New Drug Application (ANDA) approvals over the past nine months.
Besides, Ind-Ra expects the regulatory environment to remain stringent.
However, it said well-equipped companies would be able to take the advantage of a better pricing outlook emanating from supply shortages and recalls.
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“Indian companies have received a higher share of new ANDA approvals since April 2020 led by significant manufacturing facility clearances, GDUFA-II (Generic Drug User Fee Amendments), and a strong filing momentum aided by historical investments in R&D,” Ind-Ra added in a report.
“Ind-Ra has seen an increasing drug demand since the start of the C-19 pandemic led by supply chain issues, channel filling, and demand for C-19 led preventive products. In the past, too, there was drug shortage in the US due to the exit of the large generic players from unviable products.”
“Overall drug shortages in the US are leading to moderate-to-stable pricing pressures.”
Furthermore, it cited that majority of the drug recalls (91%) from the US markets are from the non or least serious category (Class-II and III recall).
Accordingly, only ‘Class-I’ drug recalls are serious in nature.