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