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Indoco Remedies share price rose more than 5 percent intraday on November 25 despite EIR from USFDA.
The company in its press release said that it has received establishment inspection report (EIR), from the US Food and
Drug Administration (USFDA) for its sterile facility (Plant II) and solid dosages facility (Plant III) at Verna,
Goa for the inspection carried out between October 7 to 15, 2019. This was a pre-approval inspection for a sterile
injectable product, with 2 observations on form 483s, which is now concluded as closed, it added.
The inspection classification of this site has been determined as VAI (Voluntary Action Indicated) by the USFDA.
“We have received the EIR in just over a month’s time from the date of inspection. Excelling at quality and compliance is one
of our top priorities, as we remain committed to meeting and exceeding standards set by the regulatory agencies globally,”
said Aditi Kare Panandikar, Managing Director of Indoco Remedies.
"This second successful PAI (Pre-Approval Inspection) at the site in less than 6 months indicates steady progress in review of Indoco’s pending ANDAs.
The company has 39 ANDAs, pending for approval from this site," she added.
At 09:38 hrs Indoco Remedies was quoting at Rs 155.00, up Rs 5.55, or 3.71 percent on the BSE.
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