 "usfda, pharma")
The pace of approvals for abbreviated new drug applications (ANDAs) by the US drug regulator has halved, compared to pre-Covid levels, revealed the latest data from India Ratings & Research (Ind-Ra).
Compared to 670 global ANDA approvals given by the US Food and Drug Administration (USFDA) in the first half (H1) of calendar year 2019, the number of approvals has halved to 328 in H12021 (calendar).
Within this, the ANDA approvals secured by Indian pharmaceutical (pharma) firms have fallen from 267 in H12019 (calendar) to 137 in H12021 (calendar) - a 49-per cent drop.
India’s share in the global ANDA
Unlock 30+ premium stories daily hand-picked by our editors, across devices on browser and app.
Pick your 5 favourite companies, get a daily email with all news updates on them.'%3E%3Cg id='Artboard-Copy' transform='translate(0 0.012)'%3E%3Cg id='_126115' transform='translate(0 0)'%3E%3Cpath id='Path' d='M17.537 1.487a.473.473 0 0 0-.467.477v12.67A2.4 2.4 0 0 1 14.7 17.06H3.3A2.4 2.4 0 0 1 .933 14.634V.966H14.587v12.29a.467.467 0 0 0 .933 0V.489a.473.473 0 0 0-.467-.477H.467A.473.473 0 0 0 0 .489V14.63a3.346 3.346 0 0 0 3.3 3.382H14.7A3.346 3.346 0 0 0 18 14.63V1.965a.467.467 0 0 0-.462-.478Z' transform='translate(0 -0.012)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-2' d='M12.676 3.955a.478.478 0 1 0 0-.955H2.508a.478.478 0 1 0 0 .955Z' transform='translate(0.124 0.166)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-3' d='M12.676 13H2.508a.478.478 0 1 0 0 .955H12.672a.478.478 0 1 0 0-.955Z' transform='translate(0.124 0.768)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Shape' d='M2 6v5.371a.484.484 0 0 0 .467.5H7.531a.484.484 0 0 0 .467-.5V6a.484.484 0 0 0-.467-.5H2.467A.484.484 0 0 0 2 6Zm.933.5H7.066v4.375H2.933Z' transform='translate(0.122 0.317)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-4' d='M12.321 5.5H8.967a.478.478 0 1 0 0 .955h3.354a.478.478 0 1 0 0-.955Z' transform='translate(0.517 0.317)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-5' d='M12.321 8H8.967a.478.478 0 1 0 0 .955h3.354a.478.478 0 1 0 0-.955Z' transform='translate(0.517 0.467)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-6' d='M12.788 10.977a.473.473 0 0 0-.467-.477H8.967a.478.478 0 1 0 0 .955h3.354a.471.471 0 0 0 .467-.478Z' transform='translate(0.517 0.617)' fill='%23c4132a'%3E%3C/path%3E%3C/g%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Full access to our intuitive epaper - clip, save, share articles from any device; newspaper archives from 2006.
Preferential invites to Business Standard events.
Curated newsletters on markets, personal finance, policy & politics, start-ups, technology, and more.