Zydus Lifesciences - Transdermal Launches To Gain Pace, Strengthen U.S. Base Business: Systematix

We see the portfolio being commercialised over next 6-12 months, and add $40- 60 mn in annual sales to Zydus Lifesciences’ US biz.

<div class="paragraphs"><p>Zydus Lifesciences Ltd. (Source: Company website)</p></div>
Zydus Lifesciences Ltd. (Source: Company website)

BQ Prime’s special research section collates quality and in-depth equity and economy research reports from across India’s top brokerages, asset managers and research agencies. These reports offer BQ Prime’s subscribers an opportunity to expand their understanding of companies, sectors and the economy. 

Systematix Research Report

The U.S. Food and Drug Administration conducted a pre-approval inspection at Zydus Lifesciences Ltd.’s Moraiya manufacturing facility from January 23-27, 2023.

The inspection pertained to transdermal products and concluded with NIL observations. We expect this successful pre-approval inspection to pave way for the launch of Zydus Lifescience' transdermal portfolio, which awaits regulatory approval.

We see the portfolio being commercialised over next six-12 months, and add $40- 60 million in annual sales to Zydus Lifesciences’ U.S. business.

The contribution from these launches could be sticky in the base and likely replace a large part of the erosion expected in Asacol HD, thereby providing durability to the base business.

Zydus Lifesciences has four to five transdermal patches filed from Moraiya, of which, one (gVivelle-Dot) was recently approved. In addition to filings from Moraiya, the company has few (three-four) other filings too – A couple from Hercon (gDuragesic Patch was recently approved), one from Matoda and another from a partner site (gRotigotine). gDuragesic patch and gVivelle-Dot have only been recently approved, but are yet to be launched commercially.

Click on the attachment to read the full report:

Systematix Zydus Lifesciences Company Update.pdf


This report is authored by an external party. BQ Prime does not vouch for the accuracy of its contents nor is responsible for them in any way. The contents of this section do not constitute investment advice. For that you must always consult an expert based on your individual needs. The views expressed in the report are that of the author entity and do not represent the views of BQ Prime.

Users have no license to copy, modify, or distribute the content without permission of the Original Owner.