Pharma Ltd has announced that it has received the marketing
authorisation approval from the United Kingdom Medicines
and Healthcare Products Regulatory Agency (UK MHRA)
for mirtazapine 15, 30 and 45mg tablets containing the
active ingredient mirtazapine.
is the second formulation approval received from the
UK MHRA for a product developed in house by the company.
With this approval, it will be easier for Aurobindo
Pharma to obtain similar marketing authorisation for
Mirtazapine tablets in the other countries of the European
Union through mutual recognition procedure. This generic
product is bio-equivalent and has the same therapeutic
effect to the innovator product, namely Zispin of Organon
is a newer antidepressant that exhibits both noradrenergic
and serotonergic activity and enjoys a market of over
$140 million in Europe.
Pharma has already filed 20 products in various EU countries,
some of which are nearing the marketing authorization
approvals. Many more filings in the EU countries are
in pipeline in the coming year.
Pharm, the company''s wholly owned subsidiary has over
100 market authorisations in Europe.