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www.aurobindo.com |
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Hyderabad, 21st June, 2005 |
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AUROBINDO RECEIVES SECOND ANDA
APPROVAL FROM US FDA FOR PEPFAR |
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Aurobindo Pharma Limited has crossed one more
milestone in its ARV (Anti-Retro Virals) filing
with US FDA. |
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Aurobindo has received tentative approval from
US FDA for Nevirapine, a key ARV in the
treatment of AIDS. Nevirapine is in the class of
drugs called non-nucleoside reverse
transcriptase inhibitors (NNRTIs), which helps
keep the AIDS virus from reproducing. This
antiretroviral drug is used in combination with
other anti-retroviral agents for the treatment
of HIV-1 infection. |
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This is the second approval received from USFDA
under PEPFAR (President’s Emergency Plan for
Aids Relief) program. Already Aurobindo has
received approval for Lamivudine. Aurobindo
Pharma Limited is one among very few most
vertically integrated companies to participate
in PEPFAR program. USD 15 billion is earmarked
for the 5-year PEPFAR program, including around
USD 1 billion per year for medicines. Approvals
for Product, Plant and Bio-Equivalence by USFDA
are important qualifying criteria to participate
in the program. Aurobindo believes that this is
another significant landmark in penetrating the
Global ARVs business. In the near term,
Aurobindo Pharma Limited expects to file a few
other relevant ARV (Anti-Retro Virals) filings. |
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About Aurobindo Pharma Limited: |
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Aurobindo Pharma Limited (www.aurobindo.com),
headquartered at Hyderabad, India, manufactures
generic pharmaceuticals and Active
Pharmaceutical Ingredients. The Company’s robust
product portfolio is spread over 6 major
therapeutic/product areas encompassing
(Antibiotics, Anti-Retrovirals, CVS, CNS,
Gastroenterologicals, and Anti-Allergics) with
around 65 APIs in the non-antibiotics and over
55 APIs in the antibiotic segment. The Company
is marketing these products globally, in over
100 countries. |
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PRESS
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