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www.aurobindo.com |
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Aurobindo receives US FDA
approval for Stavudine Capsules 15mg & 20mg |
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Aurobindo Pharma
Limited is delighted to share that the Company
has received tentative approval from the US FDA
for Stavudine capsules, 15 mg and 20 mg. This is
in addition to 30 mg and 40 mg already approved
in July 2005. Today's US FDA action tentatively
approves the total application covering 15, 20,
30 and 40 mg. The Company has already bagged
approval for several other ARVs totaling 14. |
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Stavudine is an antiviral
agent of the nucleoside analog class, which
includes zidovudine (AZT), didanosine (ddI) and
zalcitabine (ddC). The international brand name
is Zerit and is marketed by Bristol Myers
Squibb. Nucleoside analogs are thought to slow
the progression of AIDS by inhibiting HIV
replication. Data indicate that this class of
drugs may delay the onset of AIDS symptoms in
HIV-infected individuals, and may extend
survival in some. |
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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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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
