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www.aurobindo.com |
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Hyderabad, 21st November, 2005 |
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AUROBINDO RECEIVES
APPROVAL FOR CEPHALEXIN CAPSULES BY US FDA |
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Aurobindo Pharma Limited is pleased to announce
that U.S. Food Drug Administration (US FDA) has
approved its Cephalexin capsules USP 250 mg &
500 mg. |
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Aurobindo achieved another major milestone by
obtaining the first product approval from the
dedicated Cephalosporin facility (Unit VI,
situated in Medak District, Andhrapradesh,
India). |
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Aurobindo has set up three (Unit III, Unit VI,
Unit XII) multi module formulation manufacturing
facilities. Earlier products from Unit III only
contributed to the sales in the US. Product
approvals from Unit XII and Unit VI have taken
place in the last few days and Aurobindo will be
in a position to capitalize on this opportunity
with immediate effect. |
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The market opportunity for the Cephalexin
Capsules USP 250 mg and 500 mg is around USD 80
million. |
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Aurobindo is the proven leader in this
segment/product range in several markets in the
world and is looking forward to market its range
in USA. |
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Unit |
Segments |
Certifications |
Unit I
Unit IA |
CVS, CNS, anti-allergics
Cephs |
US FDA
US FDA |
Unit VIII
Unit VI |
Gastro enterologivals, ARV's
Cephs |
US FDA, WHO
Health Canada |
Unit VA
Unit XI A |
SSP's
ARV's |
Awaiting US FDA
approvals |
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Formulations |
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Unit III Oral
solids
Liquids |
Multi purpose
-do- |
US FDA, UK MHRA, WHO, Health Canada, MCC
(SA) & ANVISA
US FDA, Health Canada |
Unit VI B
Liquids |
Cephs |
US FDA, MCC,
Health Canada |
Unit XII
Liquids |
SSPs |
Health Canada, US FDA |
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Bio-equivalence centre |
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US FDA, Brazil
ANVISA, WHO |
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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 several 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)
around 65 APIs in the non-antibiotics and 55
APIs in the antibiotic segment. The Company is
marketing these products globally, in over 100
countries. |
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