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Aurobindo Pharma USA

Produces and distributes generic pharmaceuticals

Overview

Aurobindo USA supplies a broad portfolio of quality, affordable generic medicines to pharmacists and patients in the United States. Generic drugs use the same active ingredient and dosage as brand-name products and are approved through the ANDA process to deliver the same therapeutic effect at lower cost. The company differentiates itself with a large, diverse product portfolio and strong US prescription volume and market presence. Its goal is to make high-quality medicines more affordable and widely available by expanding its generic offerings while maintaining regulatory compliance.

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About Aurobindo Pharma USA

Simplify's Rating
Why Aurobindo Pharma USA is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Industrial & ManufacturingHealthcare

Company Size

1,001-5,000

Company Stage

N/A

Total Funding

N/A

Headquarters

East Windsor, CT

Founded

1994

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What believers are saying

  • FTC clearance closed the $250 million Lannett acquisition on June 29, 2026.
  • Lannett's Seymour, Indiana plant adds roughly 4 billion annual doses of U.S. capacity.
  • Aurobindo launched generic Advair Diskus, opening its inhalation franchise in the United States.

What critics are saying

  • On September 18, 2026, Aurobindo recalled 112,932 Amazon acetaminophen bottles for discolored tablets.
  • FTC divestitures of mycophenolate, niacin, pilocarpine, and rabeprazole delay integration and siphon profits.
  • Repeat quality failures risk an import alert that strands Aurobindo's U.S. generics business.

What makes Aurobindo Pharma USA unique

  • Aurobindo combines India-scale API supply with East Windsor manufacturing and U.S. distribution.
  • Lannett added inhalation and controlled-substance capabilities, including Advair Diskus launch on August 31, 2026.
  • Its pipeline holds 579 FDA approvals and 180-day exclusivity on dapagliflozin-metformin ER.

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Company News

Yahoo
Oct 3rd, 2026
Over 112,000 bottles of popular pain reliever recalled nationwide after consumer complaints.

Over 112,000 bottles of popular pain reliever recalled nationwide after consumer complaints. Alex Vance Sat, October 3, 2026 at 3:59 AM PDT * Aurobindo Pharma USA Inc. initiated a nationwide recall of Amazon Basic Care Extra Strength Acetaminophen due to consumer complaints of discolored tablets. From fever to headache relief, there's a good chance you've reached for acetaminophen at some point. Most people know acetaminophen by the brand name Tylenol, but it's also sold as a generic under a variety of store brands. But if you frequently load up your online shopping cart via Amazon, here's a notice that could apply to what's inside your medicine cabinet right now. According to an October 2 report published by the U.S. Food and Drug Administration (FDA), New Jersey-based Aurobindo Pharma USA Inc. initiated a nationwide recall of Amazon Basic Care Extra Strength Acetaminophen on September 18. "Discoloration: consumer complaints received for discolored tablets" is the given recalling reason. According to details from the National Library of Medicine, the tablets should normally appear "white to off-white." This isn't the first recall of Amazon-brand acetaminophen over discoloration. In May 2025, Aurobindo Pharma USA recalled more than 4,000 bottles of Amazon Basic Care Acetaminophen after consumers reported "a brown surface" on some of the tablets. The FDA later classified that recall as Class II. As of press time, the currently ongoing recall is labeled as "Not Yet Classified" in the FDA report. How to identify the recalled pain reliever. The FDA lists the following identifiers: 1) Amazon Extra Strength Acetaminophen (500 mg), 200-count bottle * Total affected: 14,640 bottles * NDC (National Drug Code): 72288-692-20 * UPC: 1 95515 04887 3 * Lot number: ACD125040A * Expiration date: 09/30/2027 2) Amazon Extra Strength Acetaminophen (500 mg), 500-count bottle * Total affected: 90,456 bottles * NDC: 72288-692-50 * UPC: 1 95515 04890 3 * Lot numbers: ACD124036A, ACD124030A (exp. 9/30/2027); ACD124042A (exp. 10/31/2027); ACD124048B (exp. 11/30/2027); ACD125010A (exp. 2/29/2028) 3) Amazon Extra Strength Acetaminophen (500 mg), 1000-count bottle * Total affected: 7,836 bottles * NDC: 72288-692-01 * UPC: 1 95515 04888 0 * Lot number: ACD124048A * Expiration date: 11/30/2027 The product is distributed by Amazon.com Services LLC and manufactured in India. If you purchased the recalled medicine, it's best to contact your pharmacist or healthcare provider for further guidance.

Kedia Capital
Aug 31st, 2026
Market news.

Market news. 31-Aug-2026 11:20 Hrs IST Aurobindo Pharma gains as its arm launches generic equivalent of Advair Diskus in US market. Aurobindo Pharma is currently trading at Rs. 1670.80, up by 20.80 points or 1.26% from its previous closing of Rs. 1650.00 on the BSE. The scrip opened at Rs. 1632.35 and has touched a high and low of Rs. 1,673.30 and Rs. 1632.35 respectively. So far 10724 shares were traded on the counter. The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 1682.00 on 13-Aug-2026 and a 52 week low of Rs. 1017.00 on 02-Sep-2025. Last one week high and low of the scrip stood at Rs. 1,673.30 and Rs. 1586.30 respectively. The current market cap of the company is Rs. 96,145.65 crore. The promoters holding in the company stood at 51.88%, while Institutions and Non-Institutions held 41.48% and 6.64% respectively. Aurobindo Pharma's step-down subsidiary - Lannett Company LLC has launched the generic equivalent of Advair Diskus (fluticasone propionate and salmeterol inhalation powder), a product of GSK plc, in 100/50 mcg and 250/50 mcg strengths, in the US market. Lannett Company LLC is a wholly owned subsidiary of Aurobindo Pharma USA, Inc., which is a wholly owned subsidiary of the company. This launch marks the first product from the company's inhalation pipeline to be commercialized in the US, reflecting its continued focus on expanding its portfolio of complex and differentiated inhalation products. Advair Diskus in combination therapy is indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

Trade Brains
Jun 30th, 2026
Aurobindo Pharma completes $250 million acquisition of us-based Lannett Company.

Aurobindo Pharma completes $250 million acquisition of Trade Brains group-based Lannett Company. Synopsis: Aurobindo Pharma Limited has completed the acquisition of Lannett Company through its US subsidiary, strengthening its presence in the American pharma market. The deal expands manufacturing capacity, product reach, and supports Aurobindo's long-term strategy to grow deeper in the US healthcare sector. Aurobindo Pharma USA Inc. (APUSA), a wholly owned subsidiary of Aurobindo Pharma Limited, has successfully completed its acquisition of Lannett Company, Inc. from Lannett Seller Holdco, Inc. Following clearance from the U.S. Federal Trade Commission (FTC) on June 18, 2026, the transaction became operationally effective on June 29, 2026. Under the Aurobindo group, the entity will now operate as Lannett Company LLC. According to the company's official exchange filing on June 30, 2026, the integration process has officially commenced. To secure FTC approval and maintain retail market competition, Aurobindo agreed to a consent order requiring the divestiture of four generic drug lines (including Mycophenolate Mofetil and Pilocarpine) to Quagen Pharmaceuticals. Despite these minor product divestitures, management explicitly noted that the transaction is expected to be immediately accretive to the Aurobindo Group's earnings per share (EPS) while onboarding over 400 Lannett employees. Shares of Aurobindo Pharma Limited, with a market capitalisation of Rs. 90,023.63 crore, are trading at Rs. 1,566.30, up 1.21% from its previous closing price. The stock touched an intraday high of Rs. 1,578.00 and a low of Rs. 1,547.50. It is currently trading at a P/E ratio of 25.43. The acquisition immediately adds Lannett's revenues, assets, manufacturing infrastructure, and distribution network into Aurobindo's consolidated business. While exact transaction terms were previously disclosed at $250 million, the long-term value lies beyond immediate revenue contribution. Unlike organic expansion, where new drug approvals through the ANDA pipeline can take years, this deal gives Aurobindo immediate access to an existing US product portfolio and customer base. In the near term, integration costs related to workforce transition, system alignment, and operational restructuring may create temporary margin pressure before synergies begin to reflect in earnings. Strategic interpretation. This acquisition represents more than just geographical expansion. It strengthens Aurobindo's push toward becoming a deeper US-based pharmaceutical manufacturer rather than simply an exporter. You May Like A major advantage lies in product portfolio expansion. Lannett provides Aurobindo with a dominant foothold in specialized generic segments like complex, non-opioid controlled substances (such as ADHD medications), which feature high regulatory barriers to entry. Crucially, the deal hands Aurobindo an established, massive 4-billion-dose annual capacity manufacturing facility in Seymour, Indiana, dramatically amplifying its local manufacturing presence on American soil. The second major benefit is vertical integration efficiency. Aurobindo is one of India's largest producers of Active Pharmaceutical Ingredients (APIs). By supplying its own APIs directly into Lannett's US manufacturing facilities, the company can reduce dependence on third-party procurement and improve gross margins across acquired product lines over the next 12 - 18 months. The deal also helps reduce regulatory and geopolitical risk. With growing emphasis in the US on domestic pharmaceutical manufacturing and "Made in America" healthcare supply chains, having local production capacity protects Aurobindo from potential import tariffs, supply disruptions, and policy changes while improving eligibility for government procurement contracts for essential medicines. Discover more Digital Currencies Financial Markets News Finance Education Courses From an industry perspective, the move reflects a broader trend among Indian pharma leaders shifting from being exporters to becoming integrated US manufacturers. Compared to peers like Sun Pharmaceutical Industries Limited and Dr. Reddy's Laboratories, Aurobindo is positioning itself more aggressively to compete directly with global generic giants such as Viatris Inc. and Teva Pharmaceutical Industries in their core market. Company overview. Founded in 1986 and headquartered in Hyderabad, Aurobindo Pharma Limited is among India's largest pharmaceutical companies, manufacturing generic formulations and active pharmaceutical ingredients across more than 150 countries. The company has strong global presence across antibiotics, cardiovascular drugs, antiretrovirals, CNS therapies, and gastroenterology, supported by multiple USFDA-approved manufacturing facilities worldwide. The successful completion of the Lannett acquisition strengthens Aurobindo's long-term ambition of building a larger, vertically integrated pharmaceutical platform with stronger control over manufacturing, supply chains, and direct market access in the world's largest healthcare market. 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. * Pranab Mohanty: Author Pranab is a financial analyst with experience in equities and financial modeling, with a strong understanding of data-driven analysis and quantitative techniques. He has written several analytical pieces and is deeply interested in market trends and valuation. Blending analytical thinking with financial insight, he explores strategies to better understand markets and support informed investment decisions.

WhalesBook Private Limited
Apr 7th, 2026
Aurobindo Pharma diabetes drug wins USFDA approval, targets $514M market.

Aurobindo Pharma diabetes drug wins USFDA approval, targets $514M market. HEALTHCAREBIOTECH Aurobindo Pharma has secured final USFDA approval for its Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, manufactured by subsidiary APL Healthcare. This approval allows the company to market the drug in the US, tapping into an estimated market size of US$514 million. As an early applicant, Aurobindo is eligible for 180 days of shared generic drug exclusivity. Aurobindo Pharma has received final approval from the U.S. Food & Drug Administration (USFDA) for its Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. This paves the way for the company to enter a market estimated at US$514 million, based on data for the twelve months ending February 2026. Approval details. The company announced on April 7, 2026, that its wholly owned subsidiary, APL Healthcare Limited, received the final USFDA approval. The drug is bioequivalent to AstraZeneca's Xigduo XR tablets. Manufacturing will take place at APL Healthcare's Unit-IV facility. Aurobindo can now immediately begin manufacturing and marketing the medication in the U.S. As an early applicant for the Abbreviated New Drug Application (ANDA), Aurobindo is also eligible for 180 days of shared generic drug exclusivity, offering a key advantage in the competitive U.S. market. Strategic importance and market opportunity. This approval marks a significant step for Aurobindo Pharma, strengthening its presence in the U.S. generic drug market. The medication addresses Type 2 diabetes, a prevalent condition with substantial revenue potential indicated by the market size. The 180-day exclusivity period provides a vital window to capture market share before increased generic competition. This addition brings Aurobindo's total count of US FDA-approved products to 579. Company Track record. Aurobindo Pharma has a consistent history of securing USFDA approvals for its generic drug applications. The company prioritizes building its pipeline through R&D and strategic filings. Previously, Aurobindo has launched other diabetes medications in the U.S., such as Metformin Hydrochloride Extended-Release Tablets in 2012 and Saxagliptin Tablets in 2023. The company has also benefited from early ANDA submissions leading to exclusivity periods, as seen with Prasugrel Tablets. These past successes highlight Aurobindo's focus on expanding its therapeutic offerings in major regulated markets. Manufacturing and regulatory scrutiny. Despite this approval, Aurobindo Pharma has encountered recent US FDA scrutiny regarding its manufacturing facilities. In February 2026, an inspection of its Telangana formulation unit yielded 11 procedural observations. Following this, a Rajasthan subsidiary unit was classified as 'Official Action Indicated' (OAI) by the US FDA in March 2026. Earlier, in January 2026, its Hyderabad plant received a warning letter for issues concerning batch failure investigations. The company states these observations are procedural and do not expect immediate business impact, but ongoing attention to manufacturing standards remains critical for market access and compliance. Competitive landscape. Aurobindo competes with major Indian pharmaceutical firms such as Dr. Reddy's Laboratories, Sun Pharmaceutical Industries, and Cipla, all possessing significant generic portfolios in the U.S. Dr. Reddy's launched its generic version of Kombiglyze XR in August 2023. Sun Pharma is developing specialty diabetes drugs and preparing for generic semaglutide launches. Cipla is also expanding its U.S. offerings with generics in diabetes and weight management. These competitors actively pursue market share with similar USFDA-approved generics, making timely launches and penetration vital. Market data. * The estimated market size for the product is US$514 million based on data for the twelve months ending February 2026. * Aurobindo Pharma has secured a total of 579 USFDA ANDA approvals as of March 31, 2026, comprising 554 final and 25 tentative approvals. Investor focus. * Monitor the official launch date and initial sales performance of the new diabetes medication in the U.S. * Observe how Aurobindo Pharma utilizes its 180-day exclusivity period to establish market presence. * Track the company's progress in resolving recent US FDA observations across its manufacturing facilities. * Analyze competitive landscape and market penetration against peer launches in the diabetes segment. * Watch for any further pipeline updates or new ANDA filings from Aurobindo Pharma. Disclaimer: This content is for educational and informational purposes only and does not constitute investment, financial, or trading advice, nor a recommendation to buy or sell any securities. Readers should consult a SEBI-registered advisor before making investment decisions, as markets involve risk and past performance does not guarantee future results. The publisher and authors accept no liability for any losses. Some content may be AI-generated and may contain errors; accuracy and completeness are not guaranteed. Views expressed do not reflect the publication's editorial stance.

Voice of Healthcare
Jan 2nd, 2026
Aurobindo Pharma Arm to Acquire Khandelwal Labs' Non-Oncology Business for ₹325 Cr

Aurobindo Pharma arm to acquire Khandelwal labs' non-oncology business for ₹325 cr. Aurobindo Pharma on Thursday announced that its subsidiary, Auro Pharma, will acquire the non-oncology prescription formulations business of Khandelwal Laboratories on a going concern basis through a slump sale. The acquisition will be carried out for a cash consideration of ₹325 crore, subject to customary true-up adjustments for working capital, as outlined in the definitive agreements, the company said in a regulatory filing, according to media reports. The business being acquired comprises 23 brands marketed across 67 stock-keeping units (SKUs), along with nine pipeline products. Anti-infective and pain management therapies form the core portfolios of the business. In FY25, the non-oncology prescription formulations business recorded a turnover of ₹113.5 crore and an EBITDA of ₹28.9 crore. It is supported by a field force of around 470 personnel and an extensive distribution network of over 1,600 stockists. Effective January 1, 2026, the acquisition is expected to strengthen Aurobindo Pharma's domestic formulations business by adding new brands in pain management and anti-infectives, complementing its existing product portfolio and expanding its presence in the Indian market.

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