April 17, 2023 03:29 PM EDT
Pharma
Manufacturing

FDA in­spec­tion at Lupin man­u­fac­tur­ing site un­cov­ers break­downs left un­in­ves­ti­gat­ed and da­ta ques­tions

Tyler Patchen

News Reporter

A March FDA in­spec­tion at Lupin’s man­u­fac­tur­ing site in Pi­tham­pur, In­dia has un­cov­ered qual­i­ty and oth­er per­for­mance is­sues.

The FDA’s

Endpoints News

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

BECOME A PREMIUM SUBSCRIBER
TRENDING NOW

The End­points 2024 win­ners and losers list: Who was up and who was down in bio­phar­ma

FDA ap­proves Hu­ma­cyte’s lab-grown blood ves­sels in mile­stone for re­gen­er­a­tive med­i­cine

Up­dat­ed: No­vo’s 23% weight loss with Ca­griSe­ma falls short of high ex­pec­ta­tions, new tri­al planned

Ex­clu­sive: Flori­da can­cer biotech rais­es $100M Se­ries A

Califf, on his way out at FDA, pre­dicts agency tug-of-war be­tween Ra­maswamy and RFK Jr.

Ac­cel­er­at­ed ap­proval brings Pfiz­er's BRAF in­hibitor to first-line pa­tients

A service from the Financial Times