Synopsis: Cipla’s US unit recalled Lanreotide injections after the FDA flagged issues, causing a temporary shortage. North America revenue fell 22 percent YoY, and quarterly EBITDA came in 1.5–2 percent below expectations.
This article outlines Cipla’s recent challenges in the US market, where its subsidiary, Cipla USA Inc., recalled Lanreotide injections following FDA observations at its partner facility, leading to a temporary shortage and affecting North America revenue and quarterly EBITDA.
With a market capitalization of Rs 1,07,431 crore, Cipla Ltd’s share on Tuesday made a day high of Rs 1332.95 per share, up by 0.5 percent from its previous day’s close price of Rs 1325.15 per share. The share of this company has given a return of 65 percent over the last five years
News
Cipla’s US arm, Cipla USA Inc., has begun recalling unexpired batches of Lanreotide injection, which is expected to create a temporary shortage in the market. The move follows discussions with its supply partner Pharmathen and comes after earlier updates shared by the company this year.
The recall was triggered after the US FDA classified Pharmathen’s Greece facility as “Official Action Indicated” following inspection concerns. As Lanreotide is Cipla’s largest US product with a 22 percent market share, the company expects a challenging quarter and has trimmed margin guidance to 21 percent.
Revenue Split
Cipla reported total revenue of Rs 7,074 crore, with Rs 6,746.40 crore coming from its core pharmaceuticals business. Its new ventures contributed Rs 381.48 crore, while inter-segment revenue during the period stood at Rs 953.40 crore, reflecting contributions from different business segments.
North America contributes about 21 percent of Cipla’s total revenue. The company leads the US Albuterol market with a 22 percent share and over 50 million inhalers supplied. Lanreotide production is temporarily paused after USFDA observations, with resupply expected in H1 FY27, while upcoming launches may support future growth.
The temporary pause in Lanreotide supply is expected to weigh on Cipla’s US business, which contributes about 21 percent of its total revenue. The disruption follows USFDA observations at partner Pharmathen’s facility in Greece, leading to a halt in production and recall of certain batches.
Lanreotide has been a key product in Cipla’s North America portfolio, making its absence significant for near-term revenues. At the same time, generic Revlimid (gRevlimid) contributed only a good amount in Q3 FY26, indicating a limited buffer to offset the shortfall from Lanreotide.
However, the company expects the disruption to be temporary, with resupply of Lanreotide likely in H1 FY27. Cipla is also relying on upcoming launches and its strong respiratory franchise, including Albuterol with a 22 percent US market share, to support growth.
Cipla reported that its EBITDA for the quarter came in 1.5–2 percent below internal expectations, mainly due to weaker Lanreotide performance and the completion of the generic Revlimid billing cycle, with most shipments concluded in the September quarter. As a result, North America revenue declined about 22 percent YoY, impacted by Lanreotide supply disruptions and lower Revlimid contribution.
Cipla Limited, founded in 1935 as Chemical Industrial & Pharmaceutical Laboratories Ltd, is a premier Indian multinational pharmaceutical company headquartered in Mumbai. Known for its “Caring for Life” ethos, it is a global leader in respiratory, anti-retroviral, and cardiovascular drugs.
Financial Highlights: The revenue from operations remained flat at Rs 7,074 crore in Q3 FY26 compared to Rs 7,073 crore in Q3 FY25, and EBIDT fell by 37 percent to Rs 1,255 crore in Q3 FY26 from Rs 1,989 crore in Q3 FY25. Accompanied by a net profit decline of 44 percent to Rs 674 crore in Q3 FY26 from Rs 1,575 crore in Q3 FY25, resulting in an EPS decline of 57 percent to Rs 8.37 per share in Q3 FY26.
Disclaimer: The views and investment tips expressed by investment experts/broking houses/rating agencies on tradebrains.in are their own, and not that of the website or its management. Investing in equities poses a risk of financial losses. Investors must therefore exercise due caution while investing or trading in stocks. Trade Brains Technologies Private Limited or the author are not liable for any losses caused as a result of the decision based on this article. Please consult your investment advisor before investing.
