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Informist, Thursday, Aug 22, 2024

 

--German body issues good mfg certificate to Dr Reddy's Duvvada unit

By Apoorva Choubey and Narayana Krishna 

 

MUMBAI – Germany's drug regulator has issued a good manufacturing certificate to a formulations unit of Dr Reddy's Laboratories Ltd in Duvvada, Visakhapatnam, following an inspection last month, according to a copy of the certificate accessed by Informist. Regierung von Oberbayern, or General Administration of the Free State of Bavaria, certified that the company's facility, which makes drugs in the form of injectables and freeze-dried formulations, conforms with good manufacturing guidelines in the European Union.

 

The good manufacturing practice certificate for the unit, which is named FTO-9, is valid for three years and allows the drugmaker to export products to Germany and other countries under the jurisdiction of the European Medicines Agency. This is a part of the international collaboration plan of the European Medicines Agency, in which drug regulators share inspection data and reviews in order to better manage inspections capacity, allowing more sites to be monitored and reducing unnecessary duplication.

 

Dr Reddy's makes high-value, tough-to-make niche products at the Duvvada facility, including a significant number of products in the oncology segment. The plant is also a key contributor to the drugmaker's exports revenues. On Aug 13, the US Food and Drug Administration issued an Establishment Inspection Report to Dr Reddy's Duvvada facility. 

 

The company's manufacturing process was found compliant across production of sterile products, packaging and overall quality control, the German agency said. However, the scope of the inspection, which ended on Jul 13, did not include ophthalmics, inhalants and nasal sprays, the regulator said. 

 

European operations contribute 7% to the overall revenues of Dr Reddy's. The company's revenue from Europe rose 4% on year to 5.3 bln rupees in Apr-Jun.

 

During the June quarter, the company reported better-than-expected earnings despite higher costs and pricing pressure in some markets. The company's consolidated net profit of 13.92 bln rupees was higher than the Street's estimate of 13.22 bln rupees, but the bottomline fell 1% on year. 

 

Its revenue for the June quarter rose 14% on year to 76.96 bln rupees, also higher than the expected 72.6 bln rupees. At 1459 IST, the company's shares were down over 1% at 6,981 rupees on the National Stock Exchange.  End

 

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Edited by Avishek Dutta

 

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