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www.aurobindo.com |
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US FDA approval for Abacavir
Sulfate Solution |
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Yet another 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 oral Solution. 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. With this
approval, the ARV product portfolio of Aurobindo
has increased to 14. |
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Abacavir is a key component
of the ARV regimens in various parts of the
world. This is a promising drug product used in
the pediatric AIDs population treatment. |
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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 oral solution is the version of Ziagen
Solution, 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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For further information,
please contact:
Investor Relations
Aurobindo Pharma Limited
Plot # 2, Maitri Vihar | Ameerpet
Hyderabad - 500 038 |India
Phone (Board): +91 40 5572 5000
Email : ir@aurobindo.com |
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Unit
Certifications |
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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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PRESS
ROOM
