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DRL’S BACHUPALLY UNIT FAILED TO GET GMP NOD FROM GERMAN REGULATOR

Dr Reddy’s Laboratories Bachupally Unit 2 failed to get Good Manufacturing Practices (GMP) compliance certificate from German Regulator. Only this time it has run afoul of the German regulator Regulatory Authority of Germany (Regierung von Oberbayern).

BetapharmArzneimittel GmbH, Germany (wholly owned subsidiary of DRL), received a letter from German Regulatory stating non-compliance with GMP consequent to recent inspection of the plant. Due to this, the plant will not be able to make any further exports to the European Union until next inspection.

DRL has been battling regulatory issues raised by United States Food and Drug Administration (USFDA) at a couple of its manufacturing unit in India.

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