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www.aurobindo.com |
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Hyderabad, 24th April, 2006 |
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AUROBINDO RECEIVES US FDA
APPROVAL FOR SIMVASTATIN |
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Aurobindo Pharma is proud to
announce that the US FDA has granted tentative
approval for Aurobindo’s Simvastatin Tablets USP
5 mg, 10 mg, 20 mg, 40 mg and 80 mg. |
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Zocor®, Merck’s
brand name for Simvastatin, is the second
largest brand in USA with over USD 5 Billion
annual sales and is one of the fast growing
brands. Simvastatin Tablets USP is going off
patent on 23rd June 2006 and is indicated for
the treatment of high cholesterol. |
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This is a
significant approval for Aurobindo Pharma. |
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Aurobindo manufactures both
API and formulations for Simvastatin Tablets USP
5 mg, 10 mg, 20 mg, 40 mg and 80 mg. |
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Approval of Simvastatin,
known to be a difficult product requiring
intense R & D capabilities, once again
demonstrates the R & D skills of Aurobindo
Pharma. |
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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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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
