For the Q2 concall, I think the most important question was company’s assessment on the latest observations from USFDA for Kothur facility.
Saumil Shah: So congratulations on a good set of numbers. So I wanted to know the impact of eight observations for our Kothur plant on our revenue for the current quarter. And by when we can clear these observations because it’s almost a month now?
Rajeev Nannapaneni: The inspection happened in the month of October, as you’re aware. So on November 8th, we have responded. You’re given 15 working days to respond. NATCO Pharma Limited November 15, 2023
So on November 8th, we’ve answered the given our reply to the observations and our
rectification and remediation plan based on the observation. Typically what happens is it takes about 90 days for them to make a classification of the observation. So I think 90 days starts from November 8th. So that’s on the FDA side. In terms of impact, I think the impact will be minimal because I think the company has always done this mitigation with their top products. As you’re aware, I think all our top revenue items, our top five, six revenue items have an approval from our Vizag site in addition to the Hyderabad Kothur site. Lelanomide also, which is the biggest revenue item, is also having approval from both Vizag and Hyderabad. Except for two strengths, which are 2.5 mg and 20 mg, which is about 7% of the total lelanomide. So even that also we have done the batches. It’s on stability, started stability. So we believe if you do 90 days stability and it’s a procedure called CB30. If that is also done, then even that can be moved. That was already on the way, so that is also planned. Overall, I think our impact will be minimal. So I think let’s wait for the classification of the inspection and we’ll make a decision. But as we plan every project, I think we always have a two-side strategy for all our top five
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