Archive for September 2020

Sanofi and GlaxoSmithKline announced in Security Exchange Commission (SEC) filings that the Department of Justice and the U.S. Attorney’s Office for the Eastern District of Pennsylvania have opened an investigation into their reporting of potentially contaminated Zantac (ranitidine). Source: Drug GMP Report

The European Medicines Agency (EMA) has updated its advice on impurity testing for nitrosamines, expanding it to include some biological medicines. Source: Drug GMP Report

Drugmakers successfully completed a majority of postmarketing requirements and commitments in fiscal 2019, the FDA said in its latest annual report. Source: Drug GMP Report

The European Medicines Agency’s suspended the marketing authorizations of generic drugs tested by Panexcell Clinical Laboratories at its site in Mumbai, India. Source: Drug GMP Report

A drug manufacturer in Bangalore, India, drew a warning letter from the FDA for failing to properly investigate contamination at its facility. Source: Drug GMP Report

A Mylan Laboratories active pharmaceutical ingredient (API) manufacturing facility in India drew a warning letter from the FDA for cleaning and other failures. Source: Drug GMP Report

The FDA hit Las Vegas compounder ACRx Specialty Pharmacy for poor aseptic practices and other GMP failures observed during an inspection last year. Source: Drug GMP Report

A new bill introduced by Sen. Gary Peters (D-Mich.) would give the FDA the authority to recall unsafe drug products, a power it currently does not have. Source: Drug GMP Report