Dr. Reddy’s Formulation Facility Passes EU-GMP Re-Inspection
Dr. Reddy’s Laboratories, a Hyderabad, India-headquartered pharmaceutical company, has passed a GMP re-inspection carried out by German regulators at its formulations manufacturing plant (Unit 2) in Bachupally, Hyderabad, India. The plant can now restart dispatch of approved products to the European Union (EU).
Betapharm, Dr. Reddy’s Augsburg, Germany-based subsidiary, invited the regulatory authorities for the re-inspection following a failed inspection earlier in 2017. In August 2017, German pharmaceutical regulators issued a statement of noncompliance of GMP to Dr. Reddy’s for the dosage-form manufacturing plant (Unit 2). The notice said the company would not be able to supply product from the facility to the EU until successful re-inspection of the plant.
Following the January 2018 re-inspection, the company received communication that the current status of EU GMP non-compliance is to be withdrawn from Government of Upper Bavaria–Central Authority for Supervision of Medicinal Products.
Source: Dr. Reddy’s Laboratories