Import Alert

Sun Pharma facility placed on FDA import alert

13-Dec-2022 By Ben Hargreaves

The company’s Gujarat facility has been listed under import alert, after an inspection earlier this year found it was not cGMP compliant.

OTC makers hit with US FDA warning letters

19-Feb-2018 By Staff Reporter

Two Chinese and one Korean over-the-counter (OTC) drugmakers have received US FDA warnings for violating good manufacturing practice (GMP) regulations for finished pharmaceuticals.

Data issues and misbranded chest rub land Indian drugmaker US warning

02-Nov-2017 By Staff Reporter

The US FDA has sent a warning letter to Kim Chemicals Private Ltd after finding GMP issues at its facility in Raigad, Maharashtra.

Divi's Labs' Vizag plant banned from shipping to US

23-Mar-2017 By Gareth Macdonald

Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.

Third strike for Wockhardt as API facility hit with US import alert

08-Aug-2016 By Dan Stanton

The US FDA has banned products from a third Indian manufacturing plant operated by Wockhardt.

FDA adds 4 API manufacturers to 'Red List'

19-Jul-2016 By Melissa Fassbender

Two Chinese and two Indian companies have been banned from importing APIs to the US – one manufacturer says it’s making GMP compliance a “priority.”

US FDA 2009 import ban legal NAFTA panel tells Apotex

01-Sep-2014 By Gareth Macdonald

The US FDA import ban imposed on Apotex in 2009 was legal and the firm was not treated more harshly than generics rival Teva according to a State Department arbitration panel.

US FDA issues import alert on Apotex’s Indian API facility

03-Apr-2014 By Zachary Brennan

The US FDA has banned generic drugmaker Apotex from importing drugs made at its plant in Bangalore, India after discovering GMP violations.

Sun down on latest Indian US FDA import alert

13-Mar-2014 By Dan Stanton

Sun Pharma’s antibiotic facility import alert is the latest blow to the Indian drug industry but is unlikely to impact revenues or cause US shortages, the firm says.