MUMBAI (Reuters) - Strides Arcolab, the latest Indian drug firm to draw U.S. regulators’ scrutiny over manufacturing practices, has answered June queries by the U.S. Food and Drug Administration on its drug factories, the firm’s chief executive said on Wednesday.
India, which exports pharmaceutical products worth about $12 billion every year, is seen as a key source of generic drugs for regulated markets such as the United States, Europe and Japan.
Shares in Strides Arcolab fell as much as 17.1 percent on market talk that the U.S. FDA observations, in a document known as a Form-483, might hurt its sales in the United States.
“We have submitted our response and we are confident about resolving it,” Arun Kumar, the group’s chief executive, told Reuters by telephone. “We continue to supply to the United States.”
The U.S. regulator in May banned India’s Wockhardt from shipping drugs to the United States from its factory at Waluj in western India. In February, Jubilant Life Sciences Ltd had received a warning letter from the regulator over one of its manufacturing plants.
Ranbaxy Laboratories, India’s top drugmaker by sales, is still struggling to resume supplies to the United States from its two plants in India.
The company pleaded guilty this year in a drug safety probe and agreed to pay a record $500 million in civil and criminal fines under a settlement pact with the U.S. Department of Justice.
A Form-483 highlights concerns over manufacturing practices. Failure to submit a satisfactory response can result in a ban on exports to the United States from a specific manufacturing unit.
Valued at about $673 million, Strides Arcolab shares ended Wednesday down 13.04 percent at 589.65 rupees, underperforming a fall of 0.23 percent in the Mumbai benchmark.
Reporting by Kaustubh Kulkarni; Editing by Tony Munroe and Clarence Fernandez