MUMBAI (Reuters) - The U.S. Food and Drug Administration (FDA) has raised concerns over production processes at a plant that makes oral contraceptives operated by Lupin Ltd(LUPN.NS), India's fourth-largest generic drug manufacturer by sales.
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 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 FDA's concerns come as India's generic drugmakers continue to face close regulatory scrutiny on their products. In recent months, local plants of firms including Sun Pharmaceutical Industries Ltd (SUN.NS), Dr Reddy's Laboratories Ltd (REDY.NS), and Cadila Healthcare Ltd (CADI.NS) have all come under the FDA's scanner due to production quality issues.
The Lupin plant, at Pithampur in Madhya Pradesh, produces both oral contraceptives and treatments for eye diseases for sale in the United States. The U.S. oral contraceptives market, in which Lupin is a leading supplier, is valued at about $5 billion and the firm has filed for approval of close to 36 products in that segment so far.
Lupin, which started selling oral contraceptives in the U.S. in 2011, said that since the FDA audit it has won U.S. approvals to launch one new drug and transfer production of two existing medicines to the same plant. The company also said it had received FDA approval for a generic version of Allergan Inc's (AGN.N) Lumigan opthalmic solution, which was filed from its Pithampur plant.
The FDA regularly audits plants that export products to the United States. When it issues a Form 483, it outlines conditions or practices at the plant that it believes may cause the products made there to be in violation of its standards.
The Pithampur plant is Lupin's second-largest manufacturing facility exporting to its largest market, the United States. The FDA letter could impact approvals of new drugs made at the plant, analysts at brokerage Motilal Oswal said in a note.
Lupin said the FDA in November inspected its plant in Pune in western India and did not outline any concerns.
Shares in Lupin ended down 2.5 percent, after falling as much as 5.3 percent earlier in the day. The broader Mumbai market closed 0.9 percent lower.
(Reporting by Abhishek Vishnoi and Zeba Siddiqui; Editing by Sumeet Chatterjee and Kenneth Maxwell)