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www.aurobindo.com |
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Hyderabad, March 29, 2007 |
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Cephazone,
cephalosporin sterile injectable facility in California, is
approved by US FDA and receives approval of Ceftriaxone from US
FDA |
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Aurobindo Pharma Ltd is pleased
to announce that its Joint venture, Cephazone
Pharma LLC, at California, USA, a facility
dedicated to cephalosporin injectable drugs, has
received the first ANDA approval for Ceftriaxone |
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The company has received approval
for Ceftriaxone injectable, a third generation
cephalosporin antibiotic. 250mg, 500mg, 1Gm and
2Gm single use vials for intra muscular, intra
venous use and also 1Gm and 2Gm bottles
(popularly known as piggy pack) for intravenous
use are approved. |
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Ceftriaxone is the research
innovation of Hoffmann-La Roche and often used
in respiratory infections and as a choice
antibiotic in bacterial meningitis. Besides, its
use is well documented in pediatrics in febrile
conditions to prevent possible septicemias. |
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Cephazone is a joint venture of
Aurobindo and has filed several ANDAs with US
FDA. Aurobindo has already received the facility
approval for sterile Cephalosporin APIs. |
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Cephalosporin injectables market
is an attractive opportunity in USA and
globally. Aurobindo is vertically integrated in
the cephalosporin category and enjoys a leading
position in the category. |
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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 105 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 38 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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