May 12, 2022 01:34 PM EDT
Pharma
FDA+

In­di­an man­u­fac­tur­er hit with Form 483 — again

Tyler Patchen

News Reporter

An In­dia-based gener­ics man­u­fac­tur­er is once again feel­ing the wrath of US reg­u­la­tors.

Au­robindo Phar­ma has been slapped with a Form 483 fol­low­ing an in­spec­tion …

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

Among phar­ma CEOs, the IRA now and the IRA lat­er get very dif­fer­ent re­ac­tions

Bris­tol My­ers restarts ra­dio­phar­ma­ceu­ti­cal Phase 3 tri­al, but de­lays read­out by one year

Up­dat­ed: With cost-cut­ting un­der­way, Bris­tol My­ers rais­es guid­ance, touts Phase 3 win and scraps an­oth­er

An­drew Left, short sell­er who cam­paigned against Valeant, is ac­cused of fraud by SEC

Eu­ro­pean drug reg­u­la­tor re­jects Alzheimer's drug Leqem­bi, cit­ing safe­ty con­cerns

sponsored

Crit­i­cal Junc­tures in Gene Ther­a­py Clin­i­cal Ma­te­r­i­al Man­u­fac­tur­ing: Where Do I Start? And Will It Work?

A service from the Financial Times