heartburn and ulcer pill Nexium in the United States, analysts said.
Warning letter for Strides Arcolab
India's drugmakers have come under closer scrutiny this year as the FDA, the guardian of the world's most important pharmaceuticals market, has increased its presence in the country, reflecting India's growing importance as a supplier to the United States.
India produces nearly 40 per cent of generic drugs and over-the-counter products and 10 per cent of finished dosages used in the United States. In March, India allowed the FDA to add seven inspectors, which will bring its staff in India to 19, a move that should ultimately bolster the quality of, and confidence in, Indian-made drugs
The FDA's stepped-up presence should also accelerate what some in the domestic industry hope is a more rigorous attitude towards compliance in a country whose cheap generics have made it the low-cost pharmacy to the world.
Another Indian drugmaker, Strides Arcolab Ltd, said on Monday a plant of its unit Agila Specialties Private Limited had also received a warning letter from the FDA after an inspection in June.
Mylan Inc in February agreed to buy Agila for $1.6 billion to expand its presence in the fast-growing injectable drugs market, and it was not immediately clear if the FDA action would have any bearing on the deal.
Strides said it was working with the FDA to resolve concerns cited in the warning letter in the "shortest possible time". Company officials were not available to comment on the impact on the Mylan deal.