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Aurobindo Pharma reported a total income of
Rs.271.98 crore (Rs.352.88 crore) for the second
quarter ended 30th September 2004. |
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The profit after tax stood at Rs.2.56 crore
(Rs.32.15 crore) |
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The accelerated programme for regulatory markets
has resulted in an increase in the expenditure
of about Rs.21 crore pertaining to R&D,
regulatory market filings and Bio-equivalence
studies. This has affected the profitability in
the short term whereas the revenues from the
regulated markets are expected to accrue in the
medium term. In addition, rapid increase in
solvents & fuel costs did have impact on the
profitability during the quarter due to the lag
period in passing off the enhanced costs. |
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The Company has invested significant resources
in building a mega infrastructure for APIs and
formulations. Aurobindo’s 5 units for APIs and 4
Units for formulations are designed for the
regulated market. |
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Aurobindo has been on fast forward mode with
respect to its regulatory filing strategy. The
opportunity to succeed as a vertically
integrated player with a broad product
portfolio, the new business potential in ARVs,
and the business plan around injectable
antibiotics require a rapid filing of DMFs and
ANDAs for the US/EU markets. |
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The company has accelerated the DMF/ANDA filings
programme and the Q2 2004-05 witnessed 17 DMF and 4
ANDA/Formulation dossier filings in the US/EU.
In US itself the company has filed 9 DMFs in Q2.
Over 65 Non-Betalactam APIs are contributing to
the diversification of product portfolio. |
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Aurobindo receives Citalopram approval from US
FDA |
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The company has already met with significant
success in the approvals of Mirtazapine and
Citalopram. The approval of Citalopram, which
was filed in Jan 2004, and the company’s
position amongst the first lot, reflects the
quality of filings and facilities. |
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In view of the above, the company has set up a
significant target of Bio-studies and the impact
of the above target is visible in Q2 due to an
additional Rs.21 crore in costs involved in
regulatory filings, Bio-studies and related
plant expenses. These investments are expected
to reflect in rapid ANDA filings and concomitant
revenues from regulated markets over the medium
term. |
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In addition, to accommodate the significant
number of APIs planned for regulated markets,
the company reallocated capacities for regulated
markets foregoing production capacity in lower
value added products in the short term. Four API
hubs have already filed DMFs and the API
production base has increased substantially. Two
more API hubs are expected to join the regulated
market group in the next two quarters. Three
Formulation hubs and one in USA are involved in
ANDA filings and all the formulation units have
filed ANDAs. |
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Aurobindo is now positioned to be a significant
player in US/EU generic markets. |
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