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Aurobindo Pharma Limited is pleased to announce
that US FDA (U.S. Food and Drug Administration)
has granted approval for its Abbreviated New
Drug Application (ANDA) for Citalopram HBr
Tablets 10mg, 20mg, and 40mg. The US FDA has
determined it to be bio-equivalent to the listed
drug Celexa of Forest Laboratories. |
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The API is manufactured at Unit 1 and the
formulation is manufactured at Unit 3. With this
approval Aurobindo Pharma has received its 2nd
product approval from USFDA for marketing in the
USA and looks forward for more to come in the
near future. 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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Citalopram tablets are indicated
in the treatment of depressive disorders. |
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The product had annual US brand sales of
approximately $1.4 billion (Source: IMS June
2004). |
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Aurobindo has filed over 15 DMFs
(Drug Master File) and 6
ANDAs Abbreviated
New Drug Application) 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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Aurobindo has invested
significant resources in building a mega
infrastructure for APIs and formulations to
emerge as a vertically integrated pharmaceutical
company. Aurobindo’s 5 units for APIs and 4
units for formulations are designed for the
regulated market. |
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Aurobindo Pharma Limited based at Hyderabad,
India manufactures generic pharmaceuticals and
Active Pharmaceutical Ingredients. The company’s
robust product portfolio is spread over 6 major
product areas encompassing (Antibiotics,
Anti-Retro Virals, 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 selling its products in over 100 countries. |
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