Search Results for EudraGMDP

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German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies By Zachary Brennan - Published 10 August 2017

Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories.

Categories: News, Asia, Europe, EC, FDA, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Dr. Reddy's, competent authorities, EudraGMDP

Updated: MHRA Suspends UK Company's MS License By Zachary Brennan - Published 15 September 2015

Late last month, the UK's Medicines & Healthcare products Regulatory Agency (MHRA) suspended the manufacture specials (MS) license of a UK company that recently made a push into the US.

Categories: News, Europe, MHRA, Crisis management, Distribution, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: MHRA, good distribution practice, GDP, EudraGMDP, United Kingdom

Indian API Manufacturer Faces Canadian Quarantine Over Data Integrity Issues By Michael Mezher - Published 30 June 2015

After Slovenian inspectors uncovered serious issues at Indian active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories, Health Canada has issued a voluntary quarantine for all products containing APIs sourced from the company.

Categories: News, Canada, Europe, EMA, Health Canada, Active pharmaceutical ingredients, Compliance, Distribution, Drugs, Manufacturing

Tags: Good manufacturing practice, GMP, EudraGMDP, Polydrug