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www.aurobindo.com |
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Hyderabad, 23rd May, 2006 |
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AUROBINDO RECEIVES US FDA
APPROVAL FOR ABACAVIR SULPHATE TABLETS |
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First generic version approval for
Aurobindo Pharma |
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Aurobindo Pharma is
proud to announce that the US FDA has granted
tentative approval for Abacavir Sulfate Tablets
300 mg (base). This is the first generic version
approval given by US FDA. |
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The aforesaid
product will now be available for consideration
for purchase under the PEPFAR. Aurobindo
manufactures both API and formulation for this
generic. |
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With this approval,
the ARV product portfolio of Aurobindo has
increased to 13. Abacavir is a key component of
the ARV regimens in various parts of the world. |
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Abacavir is one of the
non-nucleoside reverse transcriptase inhibitors
(NRTIs), a class of drugs that helps prevent
AIDS virus from reproducing. It is used in
combination with other antiretroviral agents for
the treatment of HIV-1 infection. Abacavir
sulfate tablet is the version of Ziagen Tablets,
an anti-HIV medication manufactured by
GlaxoSmithKline. |
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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/Statins/Diabetology,
CNS, Gastro/Uro/Kidney therapeutics, Anti
fungal/allergics/respiratory) around 65
Betalactam APIs and 123 Non-Betalactam APIs. |
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The Company markets
its products in over 100 countries. The company
has filed over 50 ANDAs and 69 DMFs for the USA
market, in addition to several filings in other
countries. The company has received approvals
for several facilities from leading regulatory
agencies like US FDA, UK MHRA, WHO, Health
Canada, MCC South Africa. |
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Unit |
Certifications |
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API |
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Unit I |
US FDA |
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Unit 1 A |
US FDA |
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Unit VI A |
Health Canada, US FDA
(pre approval over) |
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Unit VIII |
US FDA, WHO |
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Unit XI |
US FDA |
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Formulations |
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Unit III |
US FDA, UK MHRA,
WHO, Health Canada, MCC (SA), Brazil Anvisa
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Unit VI B |
US FDA, MCC (SA), Health
Canada, Brazil Anvisa |
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Unit XII |
US FDA, Health
Canada, UK MHRA, Brazil Anvisa
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For further information,
please contact: |
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Karthik Krishnan
Aurobindo Pharma Limited
Plot # 2, Maitri Vihar, Ameerpet
Hyderabad - 500 038 India
Phone (Board): +91 40 5572 5000
karthik.krishnan@aurobindo.com |
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PRESS
ROOM
