The United States Food and Drugs Administration began its inspection of Cipla’s Pithampur unit in Madhya Pradesh on June 27, CNBC-TV18 reported. Cipla said the FDA was doing a pre-approval inspection (PAI) related to a drug application made by the company.
According to CNBC-TV18 sources, the PAI is likely related to a dry-powder inhaler produced by the company, for which it has applied for approval in the US.
A PAI is conducted by the US health regulator to make sure that the manufacturing unit named in a drug application is capable of producing the drug and to verify the submitted data.
The US is a growing market for Cipla. The company’s US business posted sales worth $160 million in the March quarter, helped by its respiratory portfolio, which accounted for 23 percent of its total sales in the quarter.At 1.27 pm, Cipla shares were trading flat at Rs 933.8 on the National Stock Exchange.