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Aurobindo Pharma announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg, a generic equivalent of QVAR® Inhalation Aerosol 40 mcg and 80 mcg, marketed by Teva Branded Pharmaceutical Products R&D LLC.
This represents Aurobindo's first metered-dose inhaler (MDI) product, marking a significant milestone in the Company's expansion into complex respiratory therapies and strengthening its capabilities in the inhalation segment. The product will be manufactured at Aurobindo Pharma's Raleigh facility in North Carolina, owned by its wholly owned step-down subsidiary Aurolife Pharma LLC. The product is expected to be launched in upcoming quarters.
The US market for the approved product and newer versions of the reference product, QVAR® RediHaler, was estimated at US$301 million for the twelve months ended July 2026, according to IQVIA.
The approved ANDA is a generic equivalent of QVAR Inhalation Aerosol, marketed by Teva Branded Pharmaceutical Products R&D LLC.
Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Indicated for asthma patients who require systemic corticosteroid administration, where adding Beclomethasone Dipropionate HFA Inhalation Aerosol may reduce or eliminate the need for the systemic corticosteroids.
The product will be manufactured at Aurobindo Pharma’s Raleigh facility in North Carolina, owned by its wholly owned step-down subsidiary Aurolife Pharma LLC. The product is expected to be launched in upcoming quarters.
The US market for the approved product and newer versions of the reference product, QVAR RediHaler, was estimated at $301 million for the twelve months ended July 2026, according to IQVIA.
With this approval, Aurobindo Pharma’s cumulative USFDA ANDA approvals stand at 596, comprising 571 final approvals and 25 tentative approvals, further strengthening the Company’s portfolio of complex and differentiated products.
Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.
Aurobindo Pharma is engaged in the manufacturing and marketing of active pharmaceutical ingredients (APIs), generic pharmaceuticals, and related services.
The company's consolidated net profit jumped 25.20% to Rs 1032.56 crore on a 16.86% increase in revenue to Rs 9,105.82 crore in Q1 FY27 as compared with Q1 FY26.
The scrip fell 1.15% to currently trade at Rs 465 on the BSE.
Aurobindo Pharma Ltd is up for a third straight session in a row. The stock is quoting at Rs 1679.8, up 1.19% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.52% on the day, quoting at 23654.75. The Sensex is at 75656.63, down 0.63%. Aurobindo Pharma Ltd has risen around 1.93% in last one month.
Meanwhile, Nifty Pharma index of which Aurobindo Pharma Ltd is a constituent, has risen around 1.48% in last one month and is currently quoting at 26675.5, up 0.74% on the day. The volume in the stock stood at 7.97 lakh shares today, compared to the daily average of 8.27 lakh shares in last one month.
The benchmark September futures contract for the stock is quoting at Rs 1689, up 1.43% on the day. Aurobindo Pharma Ltd is up 60.92% in last one year as compared to a 4.88% drop in NIFTY and a 21.86% drop in the Nifty Pharma index.
The PE of the stock is 36.61 based on TTM earnings ending June 26.
Aurobindo Pharma Ltd is up for a fifth straight session today. The stock is quoting at Rs 1700.5, up 3.36% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is down around 0.42% on the day, quoting at 24073.95. The Sensex is at 76957.31, down 0.4%. Aurobindo Pharma Ltd has gained around 9.38% in last one month.
Meanwhile, Nifty Pharma index of which Aurobindo Pharma Ltd is a constituent, has gained around 0.81% in last one month and is currently quoting at 26991.85, down 0.42% on the day. The volume in the stock stood at 10.4 lakh shares today, compared to the daily average of 9.96 lakh shares in last one month.
The benchmark September futures contract for the stock is quoting at Rs 1712, up 3% on the day. Aurobindo Pharma Ltd is up 65.9% in last one year as compared to a 2.24% slide in NIFTY and a 23.41% slide in the Nifty Pharma index.
The PE of the stock is 36.43 based on TTM earnings ending June 26.
Aurobindo Pharma announced that the United States Food and Drug Administration (USFDA) inspected Raleigh Plant, North Carolina, USA, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the company, established for manufacturing Inhalers, Dermatology and Transdermal products, from 24 March 2025 to 10 April 2025. At the end of inspection, form 483 was issued with a total of 11 observations.
The Unit has now received Establishment Inspection Report (EIR), classifying the facility as 'Voluntary Action Indicated' (VAI). The USFDA has concluded that this inspection is now closed.
As this unit is classified as VAI, pending applications for multiple inhalers and other dosage forms filed from this facility can now progress through the USFDA's review process.
The company has now received the Establishment Inspection Report (EIR), which classified the facility as “Voluntary Action Indicated” (VAI). The USFDA has concluded and closed the inspection.
With the facility receiving a VAI classification, pending applications for multiple inhalers and other dosage forms manufactured at the facility can now progress through the USFDA’s review process.
The company reported a 2% rise in consolidated net profit to Rs 921.26 crore on a 4.4% increase in net sales to Rs 8,751.50 crore in Q4 FY26 over Q4 FY25.
Shares of Life Insurance Corporation of India (LIC) are banned from F&O trading on 6 August 2026.
New listing:
MV Electrosystems will make its stock market debut today. The Rs 290-crore IPO was offered in a price band of Rs 400–425 per share. The issue received bids for 75.30 crore shares against 39.87 lakh shares on offer, resulting in an overall subscription of 188.85 times.
Juniper Green Energy is also set to debut on the bourses today. The company's Rs 1,800-crore IPO, priced in the Rs 214–225 per share band, received bids for 46.96 crore shares against 5.89 crore shares on offer, translating into an overall subscription of 7.97 times.
Earnings Today:
Life Insurance Corporation of India (LIC), Hero MotoCorp, Britannia Industries, Lupin, Samvardhana Motherson International, Apollo Tyres, Blue Star, Fortis Healthcare, Crompton Greaves Consumer Electricals, Bosch Home Comfort India, Premier Energies, NCC, Emcure Pharmaceuticals, EIH, Aegis Logistics, PG Electroplast, Firstsource Solutions, Signatureglobal (India), RateGain Travel Technologies, Campus Activewear will declare their quarterly results later today.
Stocks to Watch:
Aurobindo Pharma reported 28.11% jump in consolidated net profit to Rs 1,056.56 crore in Q1 FY27 compared with Rs 824.75 crore in Q1 FY26. Revenue from operations climbed 16.30% YoY to Rs 9,150.35 crore in Q1 FY27.
PB Fintech (Policy Bazaar)’s consolidated net profit jumped 92.54% to Rs 162.89 crore on 40.08% increase in revenue from operations to Rs 1,888.28 crore in Q1 FY27 over Q1 FY26.
Biocon’s consolidated net profit surged 872.27% to Rs 142.35 crore in Q1 FY27, compared with Rs 36.76 crore in Q1 FY26. Net sales jumped 10% YoY to Rs 4,336 crore in Q1 FY27.
Neuland Laboratories reported 962.37% surge in consolidated net profit to Rs 147.67 crore in Q1 FY27 compared with Rs 13.9 crore posted in year-ago period. Net sales soared 119.16% YoY to Rs 641.58 crore in the quarter ended 30th Jun 2026.
Bikaji Foods International's consolidated net profit edged up 0.4% YoY to Rs 60.14 crore in Q1 FY27, compared with Rs 59.90 crore a year ago. Net sales grew 12.5% YoY to Rs 734.26 crore.
JK Lakshmi Cement reported 29.60% decline in standalone net profit to Rs 106.77 crore in Q1 FY27 from Rs 151.67 crore in Q1 FY26. Net sales rose 9.41% YoY to Rs 1,904.78 crore in Q1 FY27.