New Delhi: Dr. Reddy’s Laboratories said a German regulatory authority has allowed company’s Visakhapatnam-based plant to restart production for the European market (EU).
“The corrective and preventive action plan (CAPA) submitted by us has been accepted by the regulator. Consequently, the regulator has permitted production to start again from this facility for the EU market,” Dr. Reddy’s Laboratories said in a regulatory filing.
However, the regulator will re-inspect the facility by the end of 2018, it added.
In September, a German regulatory authority had issued six major observations against the Hyderabad-based drug firms’ formulations unit at Visakhapatnam in Andhra Pradesh after an inspection.
The company, however, did not elaborate on the observations which were made by the regulator related to violations of good manufacturing practices (GMP).