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March 13, 2019 01:42 PM | Healthcare

Jubilant Life receives warning letter, Aurobindo Pharma gets observations from USFDA

A host of pharmaceutical companies, including Jubilant Lifesciences, Aurobindo Pharma, have received warning letters and observations from the US Food and Drug Administration  (USFDA).

To start with, Jubilant Lifesciences' Roorkee facility received a warning letter from the USFDA. The regulator pointed out in the warning letter that there were some discrepancies, which Jubilant Lifesciences would need to solve going forward. The issues deal with consumer recalls and the fact that there were some repeated observations from the last time they had inspected the facility. Roorkee contributes around 4 percent of total sales for Jubilant.

Aurobindo Pharma’s Unit 16 has received 11 observations and was inspected from February 22 till March 1. Some of the observations, according to experts, will take some time to solve but again this particular facility is quite new. It was commissioned only in FY17-FY18 and hence the contribution of financial impact would be limited even if there is an escalation or the remediation takes longer.

Biocon has received two observations for its Bengaluru facility. This was basically for a pre-approval inspection (PAI) for its insulin manufacturing plant. The market seems to be a bit sanguine about it but there are six additional observations, which were issued following another inspection, which took place in the Bengaluru facility. So there is a little bit of a concern, which the market is probably sensing.
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