MUMBAI (Reuters) - Strides Arcolab Ltd's (NSI:STAR.NS - News) September quarter profit plummeted on forex losses and a delay in regulatory approvals but the Indian drugmaker stood by its revenue forecast of 10 billion rupees for the year.
The company said it had 18 pending approvals with the U.S. FDA and it expected to get nod for some of these products in the current quarter ending December.
"In spite of a subdued quarter and delay in product approvals for the U.S. market, the company is confident of meeting its guidance for the year," Arun Kumar, group CEO, said in a statement.
Strides said its net profit fell 93 percent in July-September to 22.2 million rupees on net sales of 1.99 billion. It had a foreign exchange loss of 70 million rupees in the period.
Its consolidated pharma revenue stood at 7.09 billion rupees for the nine months ended September, while earnings before interest, tax, depreciation and amortisation (EBITDA) for the period was at 1.4 billion rupees. The full-year EBITDA outlook is 2 billion rupees.
Strides said in September a plant of its unit Agila Specialties Private Ltd had received a warning letter from the U.S. FDA after an inspection in June.
On Thursday, it said the company took "various voluntary remedial actions to address the concerns raised by the U.S. FDA and has responded suitably within the stipulated timelines."
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 percent of generic drugs and over-the-counter products and 10 percent 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.
Mylan agreed to buy Agila for $1.6 billion in February to expand its presence in the fast-growing injectable drugs market.
(Reporting by Swati Pandey; Editing by Gopakumar Warrier)