Cipla updates on US FDA product-specific Pre-Approval Inspection

The United States Food and Drug Administration ("US FDA") conducted a PreApproval Inspection ("PAI") at the Company's Indore plant from 27th June 2022 to 1st July 2022. The Company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at the said plant. There is no data integrity observation.

The PAI is part of the routine business operations and the Company is committed to addressing these observations and will submit its response to US FDA within the stipulated time.

Shares of Cipla Limited was last trading in BSE at Rs. 930.35 as compared to the previous close of Rs. 950.10. The total number of shares traded during the day was 26084 in over 1905 trades.

The stock hit an intraday high of Rs. 950.00 and intraday low of 928.65. The net turnover during the day was Rs. 24400081.00.

Source : Equity Bulls

Keywords

Cipla INE059A01026 USFDA PAI IndorePlant PreApprovalInspection Form483