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www.aurobindo.com |
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US FDA approval for Didanosine
(Chewable) Tablets |
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Once again first generic approval |
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Aurobindo Pharma is proud to
announce that the US FDA has granted tentative
approval for Didanosine tablets (Chewable) of
strengths 100mg, 150mg & 200mg. This is the
first generic version approval of Didanosine
chewable in the world given by US FDA. |
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The 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 17. |
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Didanosine is a NRTI class of
drugs, and a key component of the ARV regimens
in various parts of the world. This molecule enjoys approximately $100
mio. of market share. |
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Didanosine helps prevent AIDS
virus from reproducing. It is used in
combination with other antiretroviral agents for
the treatment of HIV-1 infection. Didanosine is
the version of VIDEX an anti-HIV medication
manufactured by Bristol Myers Squibb. |
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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
