The share price of Indoco Remedies jumped over 4 percent intraday on Wednesday after the USFDA concluded inspection of company's Goa Unit II with two observations. The two observations issued to Goa Unit II are, however, not related to data integrity.
USFDA inspected Indico's Goa Unit II from October 7 to October 15. The stock gained over 8 percent in the last three days.
“This is the second successful Pre-Approval Inspection (PAI) of this site in less than six months, which indicates steady progress in review of our pending ANDAs. The Company has 39 ANDAs pending for approval from this site”, said Ms. Aditi Kare Panandikar, Managing Director – Indoco Remedies Ltd.
"The Inspection ended with two observations, neither of these are related to Data Integrity or the core Quality Management System and the company will respond to the FDA within the stipulated time. The site continues to maintain its VAI status," the company said in a release to the exchanges.
At 1102 hrs, Indoco Remedies was quoting at Rs 146.90, up Rs 6.35, or 4.52 percent. It has touched an intraday high of Rs 155.40 and an intraday low of Rs 134.00.
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