What's behind the flip-flop by USFDA on Aurobindo Pharma? Here's cue

What do you make of this flip flop by the FDA on Aurobindo Pharma?

See, even the FDA can make some mistakes and this is one such mistake. Rarely so, but such mistakes can be seen in the industry.

However, they have to give their judgment within 90 days after receipt of the 483 observations response. I believe it is in a hurry that they had concluded that voluntary action is sufficient for these things and issued the letter with respect to this. However, the review process might not have been completed internally and someone might have raised objections with respect to certain serious issues in regard to this injectable facility. And that is why immediately within two days they have revoked and resend their initial letter which was given earlier. There are similar examples in the US also where the approved ANDAs have been revoked because certain issues were pending.


How do you think the stock could move now?

This particular facility is an injectable facility and is an important facility for Aurobindo Pharma. Anything happening to this injectable manufacturing with respect to Aurobindo Pharma, the stock will immediately react to it because the company’s major revenue will come from this particular injectable business only. In such cases, definitely FDA is not going to stall this process, whereas, they will review it properly and then give a further justification in a very short period of time.