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www.aurobindo.com |
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Aurobindo receives USFDA
Approval for
its Zolpidem |
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Aurobindo is pleased to announce
that US FDA has approved its Zolpidem
tablets in strengths 5mg and
10mg. Zolpidem belongs to the class of
imidazopyridines(Medicenes acting
on Central nervous system).
Zolpidem is the generic version
of the brand “Ambien”
manufactured and sold by
Sanofi Aventis.
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It is used in
short term treatment of insomnia. |
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Zolpidem enjoys a market of
around $2.1 billion in the USA. |
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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
has received approvals for most of the targeted
API and formulation facilities from leading
regulatory agencies like US FDA, UK MHRA, WHO,
Health Canada, MCC South Africa. The company’s
robust product portfolio is spread over 6 major
therapeutic/product areas encompassing
Antibiotics, Anti-Retrovirals, CVS, CNS,
Gastroenterologicals, and Anti-Allergics. The
formulation portfolio is built on six technology
platforms such as immediate release generics,
SR/CR generics, Orally disintegrating/Mouth
dissolving generics, Combination products,
Sterile/Lyophilized generics and Liquids/Dry
syrups.
Aurobindo has filed over 100 DMFs
and 79 ANDAs for the USA market alone in
addition to filings in other countries. The pace
of filings is matched by rapid product approvals
from various markets. Till date Aurobindo
received 40 ANDA approvals (both final and
tentative) from US alone. Aurobindo operates in
over 100 countries and markets over 180 APIs and
250 formulations |
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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