More Stories

Informist, Thursday, Aug 22, 2024

 

--Dr Reddy's Srikakulam unit in Andhra gets EU OK for blood cancer drug

--Dr Reddy's Srikakulam unit gets EU OK for new injectable product line

 

By Apoorva Choubey and Narayana Krishna 

 

MUMBAI – Dr Reddy's Laboratories Ltd's unit at Srikakulam in Andhra Pradesh has received clearance from the German drug regulator for a new product line and cancer drug Azacitidine, a copy of the certificate accessed by Informist showed. Germany's Regierung von Oberbayern, or General Administration of the Free State of Bavaria, certified that the company's new production line, which comprises injectables and freeze-dried formulations, conforms with good manufacturing guidelines in the European Union.

 

The good manufacturing practice certificate, commonly identified as FTO-11, was issued on Monday after an inspection earlier this month, the records on the European Medicines Agency's database showed. The certification is valid for three years and allows the drugmaker to export products to Germany and other countries that fall under the jurisdiction of the EMA. This is a part of the international collaboration plan of the EMA, where drug regulators share inspection data and reviews in order to better manage inspections capacity, allowing more sites to be monitored and reducing unnecessary duplication. 

 

This approval could prove significant not only because injectables and oncology drugs are high value in nature, but also because Europe remains a focus market for the company. The company's manufacturing process was found compliant across parameters of production of sterile products, packaging and quality control, the German regulator said.

 

This plant in Srikakulam now also has the authorisation to export multi-million dollar drug Azacitidine, which is used in the treatment of blood or bone marrow disorders. The company has received the approval for Azacitidine in the strength of 25 mg per ml powder for the preparation of injection of 100 mg per vial.   

 

Dr Reddy's revenues from Europe, which make up 7% of the total sales, rose 4% on year to 5.3 bln rupees for Apr-Jun. Overall, the drugmaker reported better-than-expected earnings during the June quarter despite higher costs and pricing pressure in some markets. The company's Apr-Jun consolidated net profit of 13.92 bln rupees was higher than the Street view of 13.22 bln rupees, but was 1% down on year. 

 

Its revenue for the June quarter grew 14% on year to 76.96 bln rupees, also higher than the expected 72.6 bln rupees. Today, shares of the company ended 1.2% down at 6,980 rupees on the National Stock Exchange.  End

 

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

 

Edited by Saji George Titus

 

For users of real-time market data terminals, Informist news is available exclusively on the NSE Cogencis WorkStation.

 

Cogencis news is now Informist news. This follows the acquisition of Cogencis Information Services Ltd by NSE Data & Analytics Ltd, a 100% subsidiary of the National Stock Exchange of India Ltd. As a part of the transaction, the news department of Cogencis has been sold to Informist Media Pvt Ltd.

 

Informist Media Tel +91 (22) 6985-4000

Send comments to feedback@informistmedia.com

 

© Informist Media Pvt. Ltd. 2024. All rights reserved.