AUROPHARMA
Aurobindo Pharma Limited Receives Final US FDA Approval for Tofacitinib Tablets
Aurobindo Pharma Limited (AUROPHARMA) secures final approval from US FDA for Tofacitinib Tablets, targeting a US$494 million market.
Aurobindo Pharma Limited (NSE: AUROPHARMA) is pleased to announce that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Tofacitinib Tablets, 5 mg and 10 mg. These tablets are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xeljanz Tablets, 5 mg and 10 mg, of Pfizer Inc. The product will be manufactured at APL Healthcare Unit IV, a wholly owned subsidiary of the company, and will be launched immediately. According to IQVIA MAT data for the twelve months ending April 2026, Tofacitinib Tablets, 5 mg and 10 mg, have an estimated market size of approximately US$494 million in the U.S.
Market Potential
Tofacitinib Tablets are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and moderately to severely active ulcerative colitis. The approval marks a significant milestone for Aurobindo Pharma, expanding its portfolio of generic pharmaceuticals in the U.S. market.
Company Overview
Aurobindo Pharma Limited (www.aurobindo.com), headquartered in Hyderabad, India, is an integrated global pharmaceutical company. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries. With 30+ manufacturing and packaging facilities approved by leading regulatory agencies, Aurobindo Pharma continues to strengthen its global footprint.
As Aurobindo Pharma moves forward, it remains committed to delivering high-quality, affordable medications to patients worldwide. This approval is a testament to the company’s robust R&D capabilities and its dedication to improving patient outcomes.
Source: NSE Corporate Announcement
Fundamental & Technical Analysis of Aurobindo Pharma Limited
Aurobindo Pharma Limited belongs to the Healthcare › Drug Manufacturers – Specialty & Generic sector. Here’s a quick read on where the business and the stock stand today.
Aurobindo gains 18.8% over three months and trades near its 52-week highs. Revenue grows at 10.7% and profits at 22.1% CAGR. The market consistently rewards this kind of compounding. Not a single revenue dip or loss quarter in five years — this is a business built to last through cycles. The stock trades at 84% of its 52-week range — near its best levels of the year. Clearly, the market pays a premium for this name. Revenue grows at 10.7% and profits at 22.1%. The business is in good shape. Moreover, a stock that does not move despite strong fundamentals often offers better value than one already priced for perfection. Check Fundamentals of Aurobindo Pharma Limited.
AUROPHARMA
Aurobindo Pharma Limited Receives Final Approval for Perampanel Tablets from USFDA
Aurobindo Pharma Limited (NSE: AUROPHARMA) receives final approval from USFDA for Perampanel Tablets, set to launch in Q3FY27.
Aurobindo Pharma Limited (NSE: AUROPHARMA) is pleased to announce the receipt of final approval from the US Food & Drug Administration (USFDA) to manufacture and market Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. These tablets are bioequivalent and therapeutically equivalent to the reference listed drug, Fycompa® Tablets, of Catalyst Pharmaceuticals, Inc. The product will be manufactured at Unit -IV of APL Healthcare, a wholly-owned subsidiary of the Company, and is set to launch in Q3FY27. The approved product has an estimated market size of US$ 67 million for the twelve months ending August 2026, according to IQVIA MAT.
Significance of Approval
This approval marks a significant milestone for Aurobindo Pharma as it expands its portfolio of CNS products. Perampanel Tablets are indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 4 years and older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.
Company’s Growth and Future Prospects
With this approval, Aurobindo Pharma now has a total of 599 ANDA approvals from USFDA. The company continues to strengthen its position in the global pharmaceutical market with its robust product portfolio spread over seven major therapeutic areas. Aurobindo Pharma’s commitment to innovation and quality is evident in its extensive list of manufacturing and packaging facilities approved by leading regulatory agencies worldwide.
Aurobindo Pharma Limited remains dedicated to its mission of delivering high-quality, affordable medications to patients globally. With the launch of Perampanel Tablets, the company is poised to further its growth and contribute to improved patient outcomes in the epilepsy treatment landscape.
Source: NSE Corporate Announcement
Fundamental & Technical Analysis of Aurobindo Pharma Limited
Aurobindo Pharma Limited belongs to the Healthcare › Drug Manufacturers – Specialty & Generic sector. Here’s a quick read on where the business and the stock stand today.
Aurobindo posts a 3.5% three-month gain, but softens in the last few weeks. Revenue grows at 10.7% and profits at 22.1% CAGR. The market consistently rewards this kind of compounding. Not a single revenue dip or loss quarter in five years — this is a business built to last through cycles. The stock gives back 0.4% in the last month despite a positive three-month run. As a result, the earlier momentum appears to be fading. Both the business and the stock move in the right direction. Revenue grows at 10.7%, profits at 22.1%, and the PEG sits at 1.17 — below its growth rate. That combination is rare. Check Fundamentals of Aurobindo Pharma Limited.
AUROPHARMA
Aurobindo Pharma Limited Receives Final Approval for Beclomethasone Dipropionate HFA Inhalation Aerosol
Aurobindo Pharma Limited (NSE: AUROPHARMA) receives final approval from USFDA for Beclomethasone Dipropionate HFA Inhalation Aerosol.
Aurobindo Pharma Limited (NSE: AUROPHARMA) announced today 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 marks Aurobindo’s first metered-dose inhaler (MDI) product, signifying a significant milestone in the company’s expansion into complex respiratory therapies and strengthening its capabilities in the inhalation segment.
Manufacturing and Market Potential
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 US market for the approved product and newer versions of the reference product, QVAR® Redi Haler, was estimated at US$301 million for the twelve months ended July 2026, according to IQVIA.
Therapeutic Benefits
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.
Building on our leadership in Generics, we are now expanding into complex inhalation therapies to create the next wave of differentiated growth in the US market, stated Aurobindo Pharma Limited.
Source: NSE Corporate Announcement
Fundamental & Technical Analysis of Aurobindo Pharma Limited
Aurobindo Pharma Limited belongs to the Healthcare › Drug Manufacturers – Specialty & Generic sector. Here’s a quick read on where the business and the stock stand today.
Aurobindo rises 14.1% over three months, with buying pressure holding steady. Revenue grows at 10.7% and profits at 22.1% CAGR. The market consistently rewards this kind of compounding. Not a single revenue dip or loss quarter in five years — this is a business built to last through cycles. The stock trades at 94% of its 52-week range — near its best levels of the year. Clearly, the market pays a premium for this name. Both the business and the stock move in the right direction. Revenue grows at 10.7%, profits at 22.1%, and the PEG sits at 1.19 — below its growth rate. That combination is rare. Check Fundamentals of Aurobindo Pharma Limited.
AUROPHARMA
Aurobindo Pharma Limited Launches Generic Advair Diskus® in US Market
Aurobindo Pharma Limited (AUROPHARMA) announces the launch of generic Advair Diskus® in the US market by its subsidiary Lannett Company LLC.
Aurobindo Pharma Limited (NSE: AUROPHARMA) is pleased to announce that Lannett Company LLC, a wholly-owned subsidiary, has launched the generic equivalent of Advair Diskus® (fluticasone propionate and salmeterol inhalation powder), a product of GSK plc, in the US market. This marks the first product from Aurobindo’s inhalation pipeline to be commercialized in the US, reflecting the company’s ongoing focus on expanding its portfolio of complex and differentiated inhalation products.
Advair Diskus® for Asthma and COPD
Advair Diskus® in combination therapy is indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). This launch is a significant milestone for Aurobindo Pharma as it continues to build its robust portfolio in the respiratory therapeutic area.
Global Pharmaceutical Leader
Aurobindo Pharma Limited 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. With 30+ manufacturing and packaging facilities approved by leading regulatory agencies, Aurobindo Pharma remains committed to delivering high-quality, affordable medications worldwide.
For more information, please visit www.aurobindo.com. For further inquiries, contact Investor Relations | Corporate Communications at Phone: +91 40 667 51211 | 66725000, Email: [email protected].
Source: NSE Corporate Announcement
Fundamental & Technical Analysis of Aurobindo Pharma Limited
Aurobindo Pharma Limited belongs to the Healthcare › Drug Manufacturers – Specialty & Generic sector. Here’s a quick read on where the business and the stock stand today.
Aurobindo gains 15.3% over three months and trades near its 52-week highs. Revenue grows at 10.7% and profits at 22.1% CAGR. The market consistently rewards this kind of compounding. Not a single revenue dip or loss quarter in five years — this is a business built to last through cycles. The stock trades at 94% of its 52-week range — near its best levels of the year. Clearly, the market pays a premium for this name. Both the business and the stock move in the right direction. Revenue grows at 10.7%, profits at 22.1%, and the PEG sits at 1.15 — below its growth rate. That combination is rare. Check Fundamentals of Aurobindo Pharma Limited.
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