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Another Dr Reddy’s Plant Runs Afoul Of German Regulator

 
• By Anju Ghangurde

Dr Reddy’s Laboratories has suffered another blow, with a second manufacturing facility failing to pass muster with the German regulator. While the plant doesn’t currently make supplies to the EU, the firm’s recent run of compliance deviations threatens to erode investor confidence.

Compliance
DR REDDY'S PLANT HAS FAILED TO PASS MUSTER WITH THE GERMAN REGULATOR

Things don’t seem to be going right for Dr. Reddy's Laboratories Ltd. on the manufacturing compliance front, at least currently. The Hyderabad-based company’s formulations facility in Duvvada has failed to clear an audit by the German regulator – the second unit under scrutiny by the agency for compliance deviations over the recent past.

Dr Reddy’s informed the Bombay Stock Exchange that an audit by inspectors from Regierung von Oberbayern of its formulations site in Duvvada, Vishakapatnam, identified “zero critical and six major observations”.

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

More from Compliance

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.