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Mumbai:
Strides Arcolab Ltd announced on Wednesday that it has
received tentative approval from the United States Food
and Drug Administration (US FDA) for Efavirenz tablets
under the expedited review provisions of the President's
Emergency Plan for Aids Relief (PEPFAR) programme.
Efavirenz,
the generic version of Bristol Myers Squibb's Susvita,
is a non-nucleoside reverse transcriptase inhibitor, which
prevents the AIDS virus from reproducing in cells. Efavirenz
is used in combination with other anti-retroviral agents
for the treatment of HIV-infections and is a key component
of drug regimens for patients who are on concurrent treatment
for tuberculosis.
"We
now have ANDA/NDA approvals for all first line anti-retroviral
drugs. This will give major boost to our AIDS, TB and
Malaria (ATM) initiative particularly in Africa and South
Asian countries," Arun Kumar, vice chairman and managing
director of the company, said.
The
company also partners the Clinton Foundation to ensure
availability of affordable quality generic ARVs in least
developed countries.
The
company recently obtained tentative approvals from the
USFDA for two new drug applications for fixed dose combination
of Lamivudine/Stavudine tablets in the strength of 150/40
mg and Lamivudine / Stavudine q50/40 mg tablets co-packaged
with Nevirapine 200 mg tablets, both under the expedited
review provision of the President's Emergency Plan for
aids relief programme.
Strides
Arcolab Ltd is an exporter of branded generic pharmaceutical
products. The company employs around 1,700 people across
the globe and has a marketing presence in over 50 countries.
The
company posted consolidated profit after minority interest
and share from associates of Rs 40 crore on total income
of Rs760 crore.
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