Search Results for Dr. Reddy's

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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

Copaxone Generics: Who Will Win First Filer Exclusivity? By Zachary Brennan - Published 25 May 2017

Generic versions of Teva’s multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) are coming, but a closer look at which competitor might win the coveted 180-day exclusivity for its generic reveals an unusual and complex situation.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Copaxone, Teva, Mylan, Momenta, Synthon, Dr. Reddy's

FDA Warns Sandoz, Dr. Reddy’s Indian Sites Over Data Integrity Violations By Zachary Brennan - Published 24 November 2015

Serious data integrity violations, including the backdating of records and failing to provide pertinent data to regulators, were included in warning letters for five manufacturing facilities from both Sandoz and Dr. Reddy’s in India, according to the US Food and Drug Administration (FDA).

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Crisis management, Drugs, Government affairs, Manufacturing, Quality

Tags: Sandoz, Dr. Reddy's, FDA, warning letters, warning letters in India