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Aurobindo Pharma Ltd is pleased to inform of receiving
its first Certificate Of Suitability (COS), approval
from the European Directorate for Quality Medicines (EDQM),
for its product in the therapeutic segment of
Gastero-Enterology.
Aurobindo filed two more dmfs with US FDA making the
total no of filings to 3 (two in CNS and one in
Diabetology) with US FDA. The recent dmf is for
Citalopram, an antidepressant and the file no. is 16850.
The
Company’s new infrastructure for regulated markets,
three API facilities (Unit 1, Unit 6 and Unit 8)
comprising over 15 blocks and four formulation
facilities (Unit3, Unit 6, Unit 12 and its JV Unit at
Pomona, Losangeles) comprising 15 formulation modules,
built up during the restructuring phase, is enabling the
Company to file COS/DMF's/ANDAs in U.S. / E.U. pharma
markets at a rapid pace. The Company has so far filed
over 20 such dossiers.
By the
virtue of COS, Aurobindo Pharma Ltd will be able to gain
entry into the European Union (E.U.) Pharma market. The
company expects to receive such approvals on a routine
basis here after. |
PRESS
ROOM 
