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www.aurobindo.com |
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Aurobindo receives US FDA Final
approval
For Didanosine Oral Suspension |
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Aurobindo takes
pleasure to inform that the US FDA has granted
final approval for Aurobindo’s Didanosine Oral
Suspension (Pediatric Powder) 10 mg / ml. |
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This product is the first generic
version of the research product, Videx Pediatric
Powder for Oral Suspension, 10-mg/ml,
manufactured by Bristol Myers Squibb
Pharmaceuticals. Aurobindo manufactures both API
and formulation for this generic. |
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The total number
of ANDA approvals from US FDA stands at 38 which
include 22 final approvals and 16 tentative
approvals. |
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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)
The Company markets its products
in over 100 countries. The company has filed 77
ANDAs and 106 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. |
For further information,
please contact:
Investor Relations
Aurobindo Pharma Limited
Plot # 2, Maitri Vihar | Ameerpet
Hyderabad - 500 038 |India
Phone (Board): +91 40 6672 5000
Mobile 0 98486 67906
Email : ir@aurobindo.com |
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