Aurobindo Pharma on Friday confirmed that it has received the final approval from the US Food & Drug Administration (US FDA).
This is in relation to manufacturing and marketing droxidopa capsules of 100 mg, 200 mg and 300 mg respectively as announced in a regulatory filing.
Moreover, Droxidopa capsules are reportedly referred to as the biological version of Lundbeck NA’s Northera capsules.
The product is set to launch immediately with an estimated market size of $352 million for the twelve months ending December 2020 according to the company.
However, Droxidopa is used for diagnosis of orthostatic dizziness and light headedness in adult patients with symptomatic neurogenic orthostatic hypotension.
These are mostly caused by primary autonomic failure, dopamine beta-hydroxylase deficiency and non-diabetic autonomic neuropathy.
Currently, the company has a total of 469 ANDA approvals which includes 440 Final approvals and 29 tentative approvals from USFDA.
The drug major is known to manufacture both generic pharmaceuticals as well as active pharmaceutical ingredients.
It’s consolidated net profit hiked up by 317.70% amounting to Rs 2,946.32 crore on a 9.5% rise in net sales at Rs 6,353.13 crore in Q3 December 2020.
Further, the scrip fell down by a margin of 0.64% amounting to Rs 905.95 on the BSE while trading in the range of 901 and 921.20 so far during the day.
Also, this is the 24th abbreviated new drug application (ANDA) yet to be approved out of Unit-X formulation facility in Hyderabad used to manufacture oral products.
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