FDA hands Lupin plant 6 black marks, along with ANDA approval

Nilesh Gupta

Lupin Managing Director Nilesh Gupta recently said he expects the Indian company to introduce 15 to 20 new products to the U.S. market this year, but that was before the announcement today that the FDA had found shortcomings at one of its key plants in India. It is the latest in a long list of actions taken by the FDA against Indian drug producers that have disappointed the agency when it comes to manufacturing.

The Mumbai-based company acknowledged in a statement that the FDA had cited its plant in Pithampur near Indore with 6 observations after inspectors checked the facility out in January. The company didn't provide any insight into what kinds of manufacturing issues the FDA uncovered.

The disclosure came in an announcement that the FDA had approved Lupin's generic version of Allergan's ($AGN) Lumigan 0.03%, an ophthalmic solution used to reduce elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. The company said the FDA also recently gave it a thumbs up to move the production of two other products to that facility. It said its Bioresearch Center in Pune was inspected in November and no observations were recorded for it.

The Pithampur plant makes oral contraceptives as well as eye drugs for the U.S. market, Reuters points out. Lupin is a major supplier of contraceptives in the U.S. It is not unusual for inspectors to cite facilities for some issues during an inspection but the Indian pharma industry has become sensitive to its reputation after the FDA not only cited, but banned, a string of Indian plants in the last several years. Among others, Ranbaxy Laboratories, Sun Pharmaceutical and Wockhardt are all on that list, often over questions of whether products shipped to the U.S. actually met quality or effectiveness standards. The plants were all found to be retesting failed batches until getting passing scores, then deleting the those that were out of spec.

Lupin says it is the fifth largest generic drug supplier in the U.S. with a market share of 5.3%, but it is aiming to move up the food chain in the market. It got approvals for 9 generic products from the FDA in 2014 and Gupta this month said he expected the company to potentially double that number this year. He said Lupin is shooting for $5 billion in sales by 2018, a level of revenue that would put it into contention for being India's largest drugmaker by that measure. Sun, which is about to close a merger with Ranbaxy to solidify its place as the largest Indian pharma player, has said the combined company would have sales of $4.2 billion.

It is too bad for Allergan and Actavis ($ACT) that the FDA issues did not interfere with Lupin's launch of Lunigan. It was Allergan's second best-selling product last year with $662 million in sales, coming in second to its cosmetic drug Botox, which had $2.2 billion in sales. Actavis is buying Allergan in a $66 billion deal and will don the Allergan name when the deal is complete.

- here's the announcement
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