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Aurobindo achieves an
important mile stone - obtains UK MHRA (previously known
as UK MCA) approval.
Medicines and Healthcare products Regulatory Agency, UK
has recommended UNIT 3 formulations manufacturing
facility of Aurobindo as a site to manufacture
formulations for UK Market.
Unit 3 at Hyderabad, India
is one of the prestigious manufacturing facilities of
Aurobindo for formulations. The campus area is 8 acres
and the working area of Unit 3 in two production blocks
and five modules admeasures around 120,000 sq.ft. with a
capacity of around 2.7 billion tablets/capsules per
year. Unit 3 is dedicated for non-penicillins and non-cephalosporins
dosage formulations.
Unit 3 is also approved by
South African MCC and Brazilian ANVISA in addition holds
ISO and approvals from several other countries.
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A few weeks earlier, Aurobindo received
its first COS approval from EDQM (European Directorate
for Quality Medicines). Now, with the clearances for
the dosage formulation facility, the journey into
regulated markets begins for Aurobindo, starting with
European market. Aurobindo has filed several dossiers
with European authorities for its APIs and formulations.
Aurobindo has made
significant investments to penetrate into a) Europe b)
USA c) China and Brazil in the last three years. With
the beginning of clearances from EDQM and MHRA, and
the commencement of full-fledged operations in China
in Sep 2003, Aurobindo can look forward to its payback
from these two segments from March 2004 onwards.
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