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Drug major Lupin has received approval to market its generic bimatoprost ophthalmic solution in the US market.
The company said it has received the final approval for its product, a generic version of Allergan Inc’s Lumigan Ophthalmic Solution, from the US Food and Drug Administration (USFDA).
“Lupin Pharmaceuticals Inc (LPI), the company’s US subsidiary would commence marketing the product shortly,” it added.
The company said filing for the product with the USFDA was made from its Indore facility which was audited in January, 2015.
Two Lupin facilities, the Lupin Bioresearch Centre, Pune (LBC) and its manufacturing facility at Pithampur, near Indore were audited by the US FDA in November, 2014 and January, 2015, respectively.
“Both the audits were completed successfully with LBC not receiving any observations and the Indore facility receiving six observations (483’s),” it said.
Since then, the Indore facility has received one abbreviated new drug application (ANDA) approval and two site-transfer approvals, it added.
The Mumbai-based company’s product is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Lupin shares were trading 2.74 per cent down at Rs 1,644.60 apiece during pre-close session on the BSE.
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