1. Big setback for Dr Reddy’s Laboratories, German regulator slaps 6 observations on Visakhapatnam plant

Big setback for Dr Reddy’s Laboratories, German regulator slaps 6 observations on Visakhapatnam plant

In yet another regulatory blow to pharma major Dr Reddy’s Laboratories, a German regulatory authority has issued six major observations related to good manufacturing practices for its plant in Visakhapatnam.

By: | Hyderabad | Published: September 9, 2017 5:46 AM
Dr Reddys Laboratories, Dr Reddys Laboratories vizag plant, Dr Reddys Laboratories Visakhapatnam plant, Dr Reddys Laboratories germany, Dr Reddys Laboratories german regulator “The company will be submitting a Corrective and Preventive Action plan (CAPA) to the authorities,” DRL said. (Reuters)

In yet another regulatory blow to pharma major Dr Reddy’s Laboratories (DRL), a German regulatory authority has issued six major observations related to good manufacturing practices (GMPs) for its plant in Visakhapatnam. “The Regulatory Authority of Germany (Regierung von Oberbayern), concluded an audit for our formulations manufacturing facility in Duvvada, Visakhapatnam, with zero critical and six major observations,” the company said in a BSE notification. Products manufactured at the facility are currently being exported to the European Union (EU).

“The company will be submitting a Corrective and Preventive Action plan (CAPA) to the authorities,” DRL said. The Duvvada facility’s compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by November 2018 for continuation of its EU-GMP certification, it added.

“The auditor has cautioned that the facility will receive EU-GMP certification from the regulator up to November 2018 only when the regulator approves the CAPA,” it stated. Following this announcement, the DRL share fell as much as 7.13% to the day’s low of Rs 2,066.15 before ending at Rs 2,158.80, down 2.93% from its previous close.

Last month, DRL’s German subsidiary Betapharm Arzneimittel had said it has not received communication from the Regulatory Authority of Germany pertaining to renewal of the GMP compliance certificate of the company’s formulations manufacturing unit 2 in Bachupally near Hyderabad after its recent inspection of the plant. “Pending revocation of the non-compliance notification, the plant will not be able to make any further dispatch to the European Union until the next inspection, to be initiated by an invitation from Betapharm,” DRL had said in a statement.

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