US FDA Inspections Resume in India
US FDA Inspections Resume in India
Sector outlook
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US FDA inspections resume in India India pharma
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Figure 1
Figure 2
Products requiring pre- What will be the US FDA’s approach to inspections in India?
approval inspections, plants
with compliance issues and
those supplying high- Pre-approval inspections for Plants with an import
volume products to the US products with unmet medical need alert/warning letter/OAI status
could be of priority to the
agency, in our view
US FDA's approach
to inspections
Source: CLSA
Figure 3
Find CLSA research on Bloomberg, Thomson Reuters, FactSet and CapitalIQ - and profit from our evalu@tor proprietary database at clsa.com
Figure 4
Figure 5
50
40
30
20
10
0
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Figure 6
80
60
40
20
0
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Source: US FDA, CLSA, NAI is No Action Indicated, OAI is Official Action Indicated and VAI is Voluntary Action
Indicated
Figure 7
0
Building, equipment Organization and Production, process Records and reports
and packaging personnel and lab controls
Source: US FDA, CLSA
Figure 8
US FDA inspects facilities for pre-approval, compliance with cGMP or product specific compliance
Inspectional
Causes for observations Observations
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Companies mentioned
Alembic Pharma (N-R)
Aurobindo Pharma (ARBP IB - RS726.4 - O-PF)
Biocon (BIOS IB - RS367.1 - SELL)
Cadila Healthcare (CDH IB - RS550.1 - BUY)
Cipla (CIPLA IB - RS956.0 - BUY)
Glenmark Pharma (GNP IS - RS506.2 - SELL)
Ipca (IPCA IB - RS2,433.9 - O-PF)
Jubilant Generics (N-R)
Lupin (LPC IB - RS929.8 - SELL)
Sun Pharma (SUNP IB - RS764.5 - BUY)
Torrent Pharma (TRP IB - RS3,043.1 - BUY)
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