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German regulator denies GMP nod to DRLs Bachupally Unit 2


German regulator denies GMP nod to DRLs Bachupally Unit 2

New Delhi: Drug firm Dr Reddy’s Laboratories (DRL) said the German regulator has not renewed good manufacturing practice (GMP) compliance certificate of its formulations facility 2 in Bachupally in Hyderabad.

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

Betapharm Arzneimittel GmbH, Germany, the company’s wholly-owned arm received a communication “from the regulatory authority of Germany (Regierung 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”, it added.

Pending revocation of the non-compliance notification, the plant will not be able to make any further exports to the European Union until the next inspection, Dr Reddy’s said.

The inspection is to be initiated by an invitation from Betapharm, it added.



Source: PTI
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