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www.aurobindo.com |
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Hyderabad,
25th October, 2004 |
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FIRST PRODUCT APPROVAL
FROM USFDA RECEIVED
FORAY INTO REGULATED MARKET CROSSES FIRST
MAJOR MILESTONE
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Aurobindo Pharma Ltd, a vertically integrated
pharmaceutical company based at Hyderabad,
India, is pleased to announce that US FDA (U.S.
Food and Drug Administration) has granted
approval for its first Abbreviated New Drug
Application (ANDA) for Mirtazapine tablets
7.5mg, 15mg, 30mg and 45mg. Active
Pharmaceutical Ingredients (API) are
manufactured at Unit 1 and formulation is made
at its Unit 3. Obtaining the product and
facility approvals for large API and formulation
units without any 483 in less than one year is
considered a record. |
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Mirtazapine tablets are indicated for the
treatment of major depressive disorders. |
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Aurobindo has filed over 15 Drug Master Files (DMFs)
and 6
ANDAs with the US FDA
in the recent
past in its efforts to build a broad product
portfolio for the
US market. |
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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 Pharma Limited manufactures generic
pharmaceuticals and APIs. The company’s robust
product portfolio is spread over 6 major product
areas encompassing anti-biotics, anti-retrovirals,
CVS, CNS, gastroenterologicals, and anti-allergics
with around 65 APIs in the non-antibiotics and
over 55 APIs in the antibiotic segment. The
Company is marketing these products globally, in
over 100 countries. |
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PRESS
ROOM 