Zydus Lifesciences shares hit a fresh 52-week high of ₹1,232.10 on Tuesday, gaining 32% in 2026 so far, running ahead of an 18% rise in the Nifty Pharma Index. According to Business Standard, the stock has bounced back 47% from its 52-week low of ₹835.85 touched on March 2, 2026, and is approaching its record high of ₹1,323.90 touched on August 9, 2024. The average trading volume jumped nearly two-fold with 2.06 million shares changing hands on both NSE and BSE. At 11:05 AM, Zydus quoted 1.8% higher at ₹1,223.50, compared to a 1.4% dip in the BSE Sensex, as reported by Business Standard. The stock ended 0.6% higher at ₹1,211.10 ahead of the latest announcement on Monday.
Zydus Lifesciences announced that its USFDA inspection at the manufacturing facility at SEZ II, Ahmedabad concluded with one observation on Monday, September 28, 2026. According to CNBC TV18, the current Good Manufacturing Practices (cGMP) inspection was conducted from September 21 to September 28, 2026. The company disclosed that there were no data integrity-related observations, adding that it will work closely with the USFDA to address the observation expeditiously. This follows the company's earlier achievement on September 22-25, 2026, when its USFDA inspection of the pharmacovigilance and post-marketing surveillance system at its New Jersey office concluded with nil observations. The Ahmedabad injectable facility had received a voluntary action indicated classification last month, which was an improvement following the deficiencies cited at the June review of its Baddi facility.
This regulatory success follows Zydus Lifesciences' earlier achievement in August, when the company received final USFDA approval for its generic version of Ascorbic Acid Injection. As reported by CNBC TV18, this product has annual US sales of around $11.6 million. The approval covered Ascorbic Acid Injection USP in two strengths — 25,000 mg/50 mL and 5,000 mg/10 mL — both at a concentration of 500 mg/mL. The injection is used for short-term treatment of scurvy in adults and children aged five months and older when oral administration is not possible, insufficient or contraindicated. The application was designated as a Competitive Generic Therapy (CGT), making it eligible for potential 180-day exclusivity.
In its June-quarter results, Zydus Lifesciences reported a 35.9% year-on-year decline in profit to ₹940 crore, while revenue rose 22% to ₹8,017 crore. According to CNBC TV18, earnings before interest, taxes, depreciation and amortisation (EBITDA) fell 7.6% to ₹1,929.4 crore, with the EBITDA margin contracting to 23.4% from 31.8% a year earlier. North American formulations sales declined 12% year-on-year in constant currency for the second straight quarter, contributing 40% to revenues in Q1FY27. The company's India branded formulations business grew 19.5% year-on-year to ₹1,820 crore, contributing 23% of Q1 revenues. Chronic and sub-chronic therapies account for 54.2% of domestic formulations sales, up 360 basis points over four years, with management guiding for mid-teens growth in the India business.
The US pipeline remains robust with 30-40 products expected in FY27, including Saroglitazar for primary biliary cholangitis, which has received priority review from the US FDA. According to CNBC TV18, Saroglitazar is expected to launch early in FY28 with conservative peak sales potential of $200-300 million, significant against Zydus' current US sales of $327 million in Q1. The company is also advancing Desidustat in Phase III for sickle-cell disease and Usnoflast in Phase IIb for ALS. Its June acquisition of US-based specialty pharmaceuticals company Assertio Holdings is expected to bulk up the US branded products portfolio from 10% to 15% of US revenues. The management expects double-digit business growth with around 24% EBITDA margin and targets for branded products to exceed two-thirds of the business over the medium term.
