More Stories

Informist, Thursday, Jul. 9, 2026

 

Please click here to read all liners published on this story

--Dr Reddy's: Will be able to supply semaglutide between Q3, Q4 
--CONTEXT: Dr Reddy's management's comments on semaglutide quality issue 
--Dr Reddy's: No impact on semaglutide oral tablets 
--Dr Reddy's: Hope to resume semaglutide mkt sales late Oct, early Nov 
--Dr Reddy's: Plan to dispatch 6-7 mln semaglutide injectable pens Nov-Mar 
--Dr Reddy's: Recalled 1 batch of semaglutide injectable pens in India 
--Dr Reddy's: Alternative sources for API of no help in next few months 
--Dr Reddy's: No impact on injectables already dispatched to Canada 
--Dr Reddy's: See Canada ops affected by lack of semaglutide sales 
--Dr Reddy's: Prima facie evidence suggests no equipment change needed 
--Dr Reddy's: Don't see need for external consultants on API impurity 
--Dr Reddy's: Semaglutide demand still strong despite rising competition 

 

By Gunjan Rajput and Eshitva Prakash

 

NEW DELHI – Dr. Reddy's Laboratories Ltd. expects to resume commercial supplies of its semaglutide injections by late October or early November, after resolving an active pharmaceutical ingredient-related quality issue that has delayed its shipments, Chief Executive Officer Erez Israeli said in a conference call on Thursday. 

 

The company expects to dispatch 6–7 million semaglutide injectable pens between November and March, assuming it successfully completes validation of the revised manufacturing process by the end of September. "If this happens...commercial APIs (active pharma ingredients) can come during October...which means that the actual supply to the market can resume, let's say, late October, early November," Israeli said.

Earlier in the day, the company informed exchanges that commercial supplies of semaglutide would be delayed as certain batches failed to meet quality specifications due to an API-related issue. The management said the impurity was detected during validation of a scaled-up API manufacturing process and was limited to new validation batches that never reached the market. "The issue has nothing to do with whatever we sent to the market. It was in a scale-up batch," Israeli said.  
 

The company reiterated that there is no impact on patient safety, existing global regulatory filings or supplies of semaglutide oral tablets. "There is no impact on the supply of semaglutide oral tablets, which utilise different API sources," Israeli said.

The company said plans to manufacture semaglutide at its own facility remain intact, although timelines would shift by a few months because the facility also depends on validated API. It added that it remains committed to its long-term manufacturing partnership with OneSource Specialty Pharma Ltd.  
 

Dr. Reddy's said injectables already supplied to Canada were unaffected, though sales in the country would be hit over the next few months as fresh supplies remain on hold. "So, no impact of whatever we sent to Canada until now. The impact on the Canadian market will be because we will not be able to supply in the next couple of months," Israeli said. 

 

The company said switching to an alternative API supplier would not help in the near term because regulatory approval would take about a year. Instead, it would modify the manufacturing process and repeat validation batches. The management added that preliminary findings suggest the issue can be resolved without equipment changes, and it does not expect to require external consultants.  

Dr. Reddy's also clarified that the recall of one semaglutide injectable batch in India was unrelated to the current API issue, as the affected scale-up batches were never supplied to the market. "There is one recall in India that we initiated, and it may come because of timing, but it's nothing to do with the scale-up. The scale-up batches never went to the market, therefore there is no recall or anything like that associated with that," Israeli said. 

 

Despite increasing competition, the company said demand for semaglutide remains robust. "If we had 15 million, we could supply that also...there is no shortage of demand," Israeli said.
 

Dr. Reddy's also said it does not expect to face contractual penalties from customers because of the supply disruption, although certain advance payment arrangements might need to be renegotiated. The company acknowledged that the temporary disruption would reduce semaglutide sales in FY27 compared to its earlier expectations, as supplies planned for July through October were now unlikely. Earlier, the company planned to sell 12 million semaglutide injectables pens in FY27; now, it has narrowed this down to 6-7 million for FY27. 

 

For the March quarter, Dr. Reddy's Laboratories reported a consolidated net profit of INR 2.21 billion on revenue of INR 75.46 billion. On Thursday, its shares ended at INR 1,269.80 on the National Stock Exchange, down 5.8%.  End

 

Edited by Avishek Dutta

 

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 (11) 4220-1000

Send comments to feedback@informistmedia.com

 

© Informist Media Pvt. Ltd. 2026. All rights reserved.