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German regulator rejects GMP approval to DRL’s Bachupally Unit2

The German regulator has not renewed good manufacturing practise (GMP) compliance certificate of Dr Reddy’s Laboratories formulations facility 2 in Bachupally in Hyderabad.

Dr Reddy’s Laboratories said in a BSE filing that the communication came after a recent inspection of the plant.

It added that Betapharm Arzneimittel GmbH, Germany, the company’s wholly owned arm received a communication “from the regulatory authority of Germany (Regiergun von Oberbayern) last night, that the GMP compliance certificate in respect of company’s formulations manufacturing Unit 2 plant in Bachupally, Hyderabad, is not renewed consequent to the recent inspection of the plant.”

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