Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Manufacturing Woes Result In “Complete Response” For Lilly’s Empagliflozin

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Some analysts expect it could take six months to resolve problems at partner Boehringer Ingelheim’s German manufacturing site, where the SGLT-2 inhibitor is made. Lilly says the European filing is not affected.

You may also be interested in...



BI/Lilly Bring Third Entrant To SGLT2 Market With Jardiance Approval

The type 2 diabetes space gets more crowded as FDA hands out another approval for an SGLT-2 inhibitor after an earlier rejection in March due to manufacturing issues.

Empagliflozin Approval May Come This Year After Boehringer Resolves GMP Problems

BI/Lilly’s SGLT-2 inhibitor is to be manufactured in a facility that was subject to a May 2013 warning letter from FDA.

Empagliflozin Approval May Come This Year After Boehringer Resolves GMP Problems

BI/Lilly’s SGLT-2 inhibitor is to be manufactured in a facility that was subject to a May 2013 warning letter from FDA.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS005685

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel