USFDA approves Lupin’s plant and product, raises concern over process

Lupin Limited, India's fourth-largest generic drug manufacturer by sales, today said it has received final approval for marketing its Bimatoprost Ophthalmic Solution (0.03%) - a generic version of Allergan Inc's Lumigan Ophthalmic Solution (0.03%) - from the United States Food and Drugs Administration (USFDA).

Lupin Pharmaceuticals Inc (LPI), the company's US subsidiary would commence marketing the product shortly.

However, the FDA has now raised concerns over production processes at a plant that makes both eye treatment products and oral contraceptives, even after inspection and approval of its facilities, Lupin said.

The FDA inspected the plant in January this year, after which it issued the company a so-called Form 483, listing six observations on the manufacturing processes at the plant, Lupin said in a statement on Monday.

Lupin said the ANDA filing for the product was made from its Pithampur facility, near  Indore, which as also the Lupin Bioresearch Center at Pune (LBC) were audited by the US FDA in November 2014 and January 2015, respectively

Lupin didn't disclose the nature of the observations. Once a Form 483 is issued by the FDA, a company has 15 days to respond before the FDA takes further action.

The Lupin plant, at Pithampur in Madhya Pradesh, produces both oral contraceptives and products for treatment of eye diseases for sale in the United States.

Lupin said it had received FDA approval for a generic version of Allergan Inc's Lumigan opthalmic solution, which was filed from its Pithampur plant.

The Pithampur plant is Lupin's second-largest manufacturing facility exporting to its largest market, the United States.

The FDA and India's generic drugmakers are in a constant fight over regulatory scrutiny on drugs, with almost all major Indian pharmaceutical firms, including Sun Pharmaceutical Industries Ltd, Dr Reddy's Laboratories Ltd and Cadila Healthcare Ltd, coming under the FDA's scanner over production quality issues.