> ## Content Index > Fetch the complete content index at: https://www.bullished.co/llms.txt > Use this file to discover other available public pages before exploring further. # Dr. Reddy's CEO Says Semaglutide API Problem Is Solved, But Drug Validation Is Still Pending - URL: https://www.bullished.co/dr-reddys-ceo-says-semaglutide-api-problem-is-solved-but-drug-validation-is-still-pending-e9a19d42/ - Published: 2026-10-23T16:05:51.000Z - Updated: 2026-10-23T16:05:51.000Z - Description: Erez Israeli says orders are in hand for a November relaunch, with most volume headed to Canada. - Author: Matteo Parrino - Tags: Earnings, RDY, Industry: Healthcare [Dr. Reddy's Laboratories](https://www.bullished.co/tag/rdy/) CEO Erez Israeli said on the company's earnings call Friday that the [active-ingredient scale-up problem](https://www.benzinga.com/news/26/10/62564009/dr-reddys-laboratories-q2-2027-earnings-call-transcript?ref=bullished.co) behind its generic semaglutide supply disruption is solved, though validation of the finished drug is still pending. The company, a drugmaker built mostly on generics, expects to restart semaglutide shipments in November, subject to that validation. ## Validation is the last gate Israeli told analysts he is "very confident," citing orders already in hand, and said all necessary active ingredient has been shipped to the company's partner. "[We still need](https://www.benzinga.com/news/26/10/62564009/dr-reddys-laboratories-q2-2027-earnings-call-transcript?ref=bullished.co) to have the results of the validation," he said, adding that he is confident it will succeed. He explained that validating the finished drug made with that ingredient takes about three weeks, and that activities so far are on time. Most volume will go to Canada, with the rest primarily to Latin America and a little to Africa. Israeli said generic semaglutide is now approved in [10 countries](https://www.benzinga.com/news/26/10/62564009/dr-reddys-laboratories-q2-2027-earnings-call-transcript?ref=bullished.co) across Latin America, Africa, the Middle East, Canada and India. The target market count is now 89, he said. Regulatory reviews kept going during the supply problem because the scale-up issue was unrelated to filings, though approvals in some markets were delayed because samples had to be shipped to them. Brazil is likely to launch early in the fourth quarter. ## Volume targets stay, tentatively An analyst from Astute Investment Management noted that management still adheres to guidance of 6 to 7 million devices this year. Israeli said a run-rate of 12 to 15 million pens, which he described for the 12 months from April, is "still my estimate," but should be taken as "a very tentative number" that depends on the success of the 6 to 7 million and on approvals and competition in each market. Asked whether he felt more or less positive, he said he had not changed his attitude. In Canada, he said, only one generic is on the market now. ## A quarter without lenalidomide Revenue for the second quarter of fiscal 2027 fell 1.5% from a year earlier to Rs 8,671 crore, or $905 million, and rose 7.4% from the prior quarter, CFO M.V. Narasimham said. EBITDA margin was 20.6%, and gross margin was 52.1%. The year-over-year drop came from lower sales of lenalidomide in North America; excluding it, the base business grew at a double-digit rate. Israeli said the company is still aiming for a 25% EBITDA margin. North America generics revenue was $264 million, down 29% from a year earlier, and the company launched six products there, including the first-to-market launch of sugammadex injection. India revenue rose 17% from a year earlier, and a US FDA decision date on abatacept, a biosimilar, is December 22, with Israeli saying there is a chance of a rejection letter. The next checkpoint is the three-week drug validation, with first shipments planned for November. ### Sources - [Dr Reddy's Laboratories Q2 2027 Earnings Call Transcript](https://www.benzinga.com/news/26/10/62564009/dr-reddys-laboratories-q2-2027-earnings-call-transcript?ref=bullished.co) — benzinga.com ### More on Dr. Reddy's Laboratories - [Dr. Reddy's Gets India Nod For Zytorvi In Esophageal Cancer, Citing 42% Lower Risk Of Disease Or Death](https://www.bullished.co/dr-reddys-gets-india-nod-for-zytorvi-in-esophageal-cancer-citing-42-lower-risk-of-disease-9a127c21/) [All Dr. Reddy's Laboratories (RDY) coverage →](https://www.bullished.co/tag/rdy/)