Mumbai: Domestic pharma companies received
more than 300 approvals in 2017 to launch generic drugs in the US, which is an
all-time high. The clearances came despite regulatory pressure from the US Food
and Drug Administration (FDA), and unprecedented warning letters issued to the
pharma companies’ facilities.
The final approvals for
Indian players are up by nearly 43% from 211 in 2016, and corner about 40% of
all global filings in the highly lucrative around $70-billion US market. This,
even as all drug biggies — including Zydus, Sun Pharma, Dr Reddy’s and Cipla —
faced regulatory ire, while some were pulled up for manufacturing lapses by the
US regulator during last year.
In terms of each company,
Zydus leads with 66 approvals in 2017, followed by Aurobindo
(52), Glenmark (18), Lupin (17), Gland Pharma (16) and Cipla
(10). Zydus cornered a majority of US filings as its Moraiya
facility, which contributes about 60% of US sales, came out from under USFDA
scanner in June last year. Sun Pharma remained static at 10 approvals, due to
its Halol plant continuing under the regulatory glare.
The US generics market, a
key driver of Indian pharma’s growth, has always been a dynamic market. But the
pace of change has accelerated in the last few years. The increase in
competition and consolidation of distribution channels have led to the US
generics business getting commoditised. Price erosion has been at an all-time
high and this has impacted operating margins significantly. Major domestic
companies earn at least 40% of their overall sales from the US.
Glenmark Pharma chairman
& MD Glenn Saldanha says, “While the number of ANDA (abbreviated new drug
application) approvals continue to remain strong for us, we, however, have
begun the process of transitioning the US business to a specialty/innovation
business.”
Source:THE TIMES OF INDIA-25th January,2018
