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The USFDA inspected Indoco Remedies' sterile manufacturing facility in Goa (Plant II) from October 7-15. “This is the second successful pre-approval inspection of this site in less than six months, which indicates steady progress in the review of our pending ANDAs.
The company has 39 ANDAs pending for approval from this site,” said Aditi Kare Panandikar, Managing Director, Indoco Remedies, in a notice to the exchanges. The inspection ended with two observations, neither of which are related to data integrity or the core quality management system. The company said it will respond to the FDA within the stipulated time, the release added. The stock closed flat at ₹140.50 on the BSE.
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