Laurus Labs - Can Business Transform to Next Level?

[Chins]

@singhvir

Going to the Orange book site at link Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations and search based on the “Search by Applicant (Company)” and by giving name Laurus Labs, gets the below list and none of the drug is classified with TE code “BX” for Laurus Labs. My interpretation is that this is not impacting any of Laurus Labs drug otherwise they FDA would have changed the TE code to BX already as stated by FDA in Q&A.

Just to confirm that this is indeed the right interpretation:

Searching the Orange Book for Lupin does show 9 drugs classified as BX, while all of Laurus’ approvals remain as AB.

@zahare2001

By no means is this the entire list of affected products, and we believe the FDA database will continue to update over the next few days. The companies with maximum TE rating changes in FDA orange book in recent days are Amneal (11), Lupin (6) and Emcure (4).

Jefferies’ claim that the list is incomplete could be true, as Lupin is now up to 9 rating changes, Amneal is up to 31. (Although it’s possible that some may already have had BX status and aren’t new changes, but I don’t track these companies)

@vnktshb

Checked with Laurus through a contact. There is just 1 product in US FDA list, which impacts Laurus a little. That too is so small that it is not even meaningful. US FDA had informed them about this in March 2021. They have already taken corrective action.

If the information from this source is true, we should expect one rating change in a few days.

Disclosure: invested.