German Regulators Approve Corrective Plan for Dr. Reddy’s Dosage-Form PlantBy
German regulatory authorities have approved Dr. Reddy’s Laboratories’ corrective and preventive action plan for its formulations manufacturing facility in Duvvada, Visakhapatnam, India.
Consequently, German regulatory authorities have permitted production to start again from this facility for the European Union market and will re-inspect this facility by the end of 2018.
In March 2017, a facility in Duvvada was also cited by the US Food and Drug Administration (FDA) when the agency issued a Form 483 with 13 observations.
These violations and observations are part of ongoing manufacturing issues for the company. In August 2017, German regulatory authorities issued a statement of noncompliance of good manufacturing practice (GMP) to Dr. Reddy’s for its dosage-form manufacturing plant (Unit 2) in Bachupally, Hyderabad, India. The company was cited for non-compliance in manufacturing for the following areas: non-sterile products (processing operations for several dosage forms [hard-shell capsules, tablets, and other coated tablets and granules]); primary packaging (hard-shell capsules, soft-shell capsules, tablets, and other non-sterile medicinal products [coated tablets and granules]); secondary packaging; and quality-control testing (microbiological/non-sterility and chemical/physical). The company was cited for critical deficiencies in the plant’s pharmaceutical quality system, deviation and out-of-specification management, and cleaning protocols.
The notice, which was issued in early August 2017, meant that the company would not be able to supply product from the facility to the European Union until successful re-inspection of the plant, to be initiated by invitation from betapharm, Dr. Reddy’s Augsburg, Germany-based subsidiary.
Additionally, in May 2017, following the FDA citation for the Duvvada facility, Dr. Reddy’s received a Form 483 with 11 observations from the FDA for its plant in Hyderabad. In April 2017, the FDA also issued a Form 483 with two observations on the company’s active pharmaceutical ingredient manufacturing plant in Srikakulam, Andhra Pradesh, India.
The Duvvada facility was among three Dr. Reddy’s facilities that were named in an FDA Warning Letter received by the company in November 2015. In that Warning Letter, the FDA inspected three of Dr. Reddy’s Indian facilities in Ranasthalam, Srikakulam District from November 17 to 21, 2014; Tripuraram, Nalgonda District from January 26 to 31, 2015, and Duvvada from February 26 to March 6, 2015. The FDA identified cGMP deviations for the manufacture of active pharmaceutical ingredients at the Ranasthalam and Tripuraram facilities and found violations of cGMP regulations for finished pharmaceuticals at the Duvvada facility.
In a separate development, Dr. Reddy’s also said the company has been served in a US securities class action lawsuit. Dr. Reddy’s says it believes the claims are without merit and that it intends to defend itself against the allegations.