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The approval covers a product that is the first AB-rated generic therapeutic equivalent of Ventolin HFA, originally marketed by GlaxoSmithKline.
The drug is indicated for the treatment or prevention of bronchospasm in adults and children aged four years and above with reversible obstructive airway disease. It is also used to prevent exercise-induced bronchospasm in patients in the same age group.
Cipla said the approval strengthens its respiratory portfolio in the U.S. market. The company already has approved generics for both Ventolin HFA and Proventil HFA.
According to data from IQVIA, the total U.S. market for albuterol inhalers is estimated at around $1.5 billion.
The development is seen as a positive for Cipla’s U.S. business, particularly in the respiratory segment, where the company continues to expand its presence with a differentiated portfolio.
Commenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla, said: “This marks an important milestone for Cipla and reflects our strong scientific and regulatory capabilities in complex inhalation products. Lung health remains at the heart of all our offerings and follows a singular, distilled objective, to build a sustainable and differentiated portfolio for patients globally.”
Marc Falkin, Chief Executive Officer, Cipla North America, added: “Strengthening our U.S. respiratory franchise, the product will be manufactured at our newly constructed, dedicated inhalation facility in Fall River, Massachusetts, reinforcing both supply resilience and our domestic manufacturing footprint. With planned volume ramp-up, we expect to drive meaningful difference in the lives of patients.”
Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolios in our home markets of India, South Africa, North America, and key regulated and emerging markets.
The company reported 56.96% decrease in consolidated net profit to Rs 675.80 crore in Q3 FY26 as against Rs 1,570.51 crore in Q3 FY25. Total revenue from operations marginally rose 0.02% YoY to Rs 7,074.48 crore in Q3 FY26.
Cipla Ltd is up for a third straight session in a row. The stock is quoting at Rs 1288.9, up 4.25% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.75% on the day, quoting at 24195.15. The Sensex is at 77763.49, down 0.96%. Cipla Ltd has risen around 5.7% in last one month.
Meanwhile, Nifty Pharma index of which Cipla Ltd is a constituent, has risen around 3.23% in last one month and is currently quoting at 22455.45, up 2.24% on the day. The volume in the stock stood at 30.64 lakh shares today, compared to the daily average of 18.9 lakh shares in last one month.
The benchmark April futures contract for the stock is quoting at Rs 1286.8, up 3.91% on the day. Cipla Ltd is down 16.94% in last one year as compared to a 0.21% drop in NIFTY and a 4.48% drop in the Nifty Pharma index.
The PE of the stock is 21.77 based on TTM earnings ending December 25.
The inspection was a routine current good manufacturing practices (cGMP) inspection and a pre-approval inspection (PAI).
On conclusion of the inspection, the Company received two inspectional observations in Form 483.
'The company will work closely with the US FDA and is committed to address these comprehensively within stipulated time,” Cipla said in a statement.
The scrip had added 0.61% to end at Rs 1238.30 on the BSE on Friday.
Total revenue from operations marginally rose 0.02% to Rs 7,074.48 crore in Q3 FY26 as against Rs 7,072.97 crore in Q3 FY25.
Profit before exceptional items and tax were at Rs 1,169.02 crore in Q3 FY26, down 38.98% as against Rs 1,916.09 crore in Q3 FY25. The company reported exceptional loss of Rs 275.91 crore in Q3 FY26.
EBITDA declined 36.9% to Rs 1,255 crore in Q3 FY26, as against Rs 1,989 crore reported in Q3 FY25. The EBITDA margin remained stable at 17.7%.
The company’s One-India business reported a strong 10% year-on-year growth in Q3, driven by improved performance across key segments. The company’s chronic portfolio share increased to 62.3%, reflecting a healthier product mix in the market.
The North America business reported quarterly revenue of $167 million. Albuterol ranked No. 1 in the overall U.S. Albuterol MDI market, commanding a 22% market share. The FY27 pipeline includes four major respiratory launches, including gAdvair. During the quarter, the business launched gVictoza and expects to introduce three more peptide assets in FY27, with three of the four respiratory assets filed from U.S. facilities.
In the South African private market, the company posted secondary growth of 6.3%, ahead of the market’s 5.7% growth, with its prescription business retaining the No. 2 position.
In Emerging Markets and Europe, the company’s focused market strategy drove 7% year-on-year growth in USD terms, supported by strong performance across both DTM and B2B segments.
The company’s R&D investments stood at Rs 494 crore, representing 7% of sales and marking a 37.4% year-on-year increase, driven by higher product filings and ongoing development initiatives.
The firm maintained a strong net cash position of Rs 10,229 crore, with debt largely comprising lease liabilities.
Umang Vohra and Achin Gupta, MD and Global CEO, Cipla, said the company continues to make solid progress across its key markets. Global revenues for Q3FY26 stood at INR 7,074 crore, despite a decline in gRevlimid sales. The OneIndia business grew 10% YoY, while the Branded Prescription segment delivered double-digit growth, led by key therapies outpacing the market. Trade Generics posted healthy gains, and Anchor brands in the Consumer Health Business maintained their leadership position.
The US business recorded revenue of $167 million, with upcoming launches expected to offset the gRevlimid decline and drive long-term growth. In South Africa, the private business continued to outperform the market, while Emerging Markets and Europe grew 7% YoY in USD terms, driven by a focused market strategy. Looking ahead, Cipla said it will focus on expanding key markets, strengthening flagship brands, investing in its pipeline, and resolving regulatory matters.
Cipla Ltd dropped for a fifth straight session today. The stock is quoting at Rs 1389.6, down 0.57% on the day as on 13:19 IST on the NSE. The benchmark NIFTY is down around 0.61% on the day, quoting at 25538.45. The Sensex is at 83093.05, down 0.57%.Cipla Ltd has lost around 8.15% in last one month.Meanwhile, Nifty Pharma index of which Cipla Ltd is a constituent, has eased around 3.39% in last one month and is currently quoting at 22217.05, down 0.3% on the day. The volume in the stock stood at 11.27 lakh shares today, compared to the daily average of 17.66 lakh shares in last one month.
The benchmark January futures contract for the stock is quoting at Rs 1391, down 0.42% on the day. Cipla Ltd tumbled 3.86% in last one year as compared to a 9.4% rally in NIFTY and a 0.15% fall in the Nifty Pharma index.
The PE of the stock is 21.72 based on TTM earnings ending September 25.
Mahindra & Mahindra Financial Services Ltd, CSB Bank Ltd, ZF Commercial Vehicle Control System India Ltd and Allied Blenders & Distillers Ltd are among the other losers in the BSE's 'A' group today, 07 January 2026.
Cipla Ltd lost 4.26% to Rs 1465.2 at 14:45 IST.The stock was the biggest loser in the BSE's 'A' group.On the BSE, 3.55 lakh shares were traded on the counter so far as against the average daily volumes of 95734 shares in the past one month.
Mahindra & Mahindra Financial Services Ltd tumbled 4.14% to Rs 358.95. The stock was the second biggest loser in 'A' group.On the BSE, 3.72 lakh shares were traded on the counter so far as against the average daily volumes of 2.09 lakh shares in the past one month.
CSB Bank Ltd crashed 3.54% to Rs 517.2. The stock was the third biggest loser in 'A' group.On the BSE, 57791 shares were traded on the counter so far as against the average daily volumes of 86720 shares in the past one month.
ZF Commercial Vehicle Control System India Ltd pared 3.48% to Rs 14750.2. The stock was the fourth biggest loser in 'A' group.On the BSE, 677 shares were traded on the counter so far as against the average daily volumes of 754 shares in the past one month.
Allied Blenders & Distillers Ltd corrected 3.47% to Rs 532.15. The stock was the fifth biggest loser in 'A' group.On the BSE, 65307 shares were traded on the counter so far as against the average daily volumes of 25511 shares in the past one month.