Lupin Facility Cited with Six Observations by FDABy
Lupin Limited has received final approval for its Bimatoprost Ophthalmic Solution, 0.03% from the US Food and Drugs Administration (FDA) to market a generic version of Allergan Inc.’s LumiganÃ‚ Ophthalmic Solution, 0.03%. Lupin Pharmaceuticals Inc. (LPI), the company’s US subsidiary will begin marketing the product shortly. Lupin’s Bimatoprost Ophthalmic Solution, 0.03% is the generic equivalent of LumiganÃ‚Â® Ophthalmic Solution, 0.03% and is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Lupin’s Bimatoprost Ophthalmic Solution, 0.03% filing was made from its Indore facility which was audited in January, 2015. Two Lupin facilities in India, the Lupin Bioresearch Center, 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. Since then, the Indore facility has received 1 abbreviated new drug application approval and two site-transfer approvals.