Aurobindo Pharma Explained

Aurobindo Pharma Limited
Logo Alt:Aurobindo Pharma's Logo
Type:Public
Traded As:
Industry:Pharmaceuticals
Predecessors:-->
Successors:-->
Founded:1986
Founders:V. Ramprasad Reddy
K. Nityananda Reddy[1]
Hq Location:Hyderabad, Telangana, India
Revenue: (FY24)[2]
Operating Income: (FY24)
Net Income: (FY24)
Assets: (2020)[3]
Equity: (2020)
Owners:-->
Num Employees:23,000[4]
Num Employees Year:2020

Aurobindo Pharma Limited is an Indian multinational pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's area of activity includes six major therapeutic and product areas: antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterologicals, and anti-allergics.[5] The company markets these products in over 125 countries. Its marketing partners include AstraZeneca[6] and Pfizer.[7]

History

The company commenced operations in 1988–89 with a single unit manufacturing semi-synthetic penicillin (SSP) in Puducherry.[8] Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. Aurobindo Pharma also has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.

Aurobindo Pharma features among the top 10 companies in India in terms of consolidated revenues. Aurobindo exports to over 125 countries with more than 70% of its revenues derived out of international operations.

In 2014, Aurobindo purchased the generic operations of Actavis in 7 Western European countries for $41 million.[9] [10]

Business expansion

Aurobindo Pharma plans to expand its product portfolio with high-value products in oncology, hormones, biosimilars and novel drug delivery solutions like depot injections, inhalers, patches and films. It has also set its sights on geographic expansion in new territories like Poland, Italy, Spain, Czech Republic, Portugal and France, as the generic drug market in these countries is relatively small.[11]

In 2017, Aurobindo Pharma inked a pact to acquire Portugal's Generis Farmaceutica SA from Magnum Capital Partners for a consideration of €135 million.[12] It also acquired four biosimilar products from Swiss firm TL Biopharmaceutical AG.[13]

Aurobindo Pharma Ltd. signed a definitive agreement to purchase the Apotex businesses in Poland, the Czech Republic, the Netherlands, Spain and Belgium. The agreement is conditional on the receipt of competition clearances for the transaction by the Dutch and Polish authorities. As part of the proposed sale, Apotex will enter into a transitional manufacturing and supply arrangement with Aurobindo to support the ongoing growth plans of these businesses.[14]

In May 2024, TheraNym Biologics, a wholly-owned subsidiary of Aurobindo Pharma Ltd signed a pact with Merck & Co. for expanding its biologics manufacturing facilities and exploring contract manufacturing operations for biologics.[15]

Legal issues

In December 2016, 20 American attorneys general filed a civil complaint accusing Aurobindo Pharma of a coordinated scheme to artificially maintain high prices for a generic antibiotic and diabetes drug. The complaint alleged price collusion schemes between six pharmaceutical firms including informal gatherings, telephone calls, and text messages.[16]

On 11 April 2018, Aurobindo was featured in the Dutch documentary television program Zembla.[17] It details accusations against the company of both environmental damage and poor working conditions for their employees in Hyderabad, India.

On 20 June 2019, Aurobindo received a warning letter from the USFDA after an inspection of its drug manufacturing facility, Aurobindo Pharma Limited in Pydibhimavaram, Srikakulam District, Andhra Pradesh.[18] The warning letter summarized significant deviations from current good manufacturing practices (cGMP) for active pharmaceutical ingredients (API).

On 7 October 2019, Aurobindo said it received seven observations from the USFDA for its unit-7 formulation plant in Telangana, with regard to potentially misleading documentation.[19] This caused its share prices to drop over 20%.[20]

Recalls

In 2018,[21] and 2019,[22] Aurobindo Pharma USA recalled tablets containing valsartan due to the detection of N-Nitrosodiethylamine (NDEA) which is a probable human carcinogen.

In November 2019, Aurobindo Pharma USA recalled ranitidine tablets, capsules, and syrup due to the detection of unacceptable levels of N-nitrosodimethylamine (NDMA).[23]

See also

Notes and References

  1. Web site: Aurobindo Overview.
  2. Web site: Earnings Presentation-Q4 FY 2023-24 . Aurobondo Pharma . 29 May 2024.
  3. Web site: Aurobindo Pharma Ltd. Financial Statements . moneycontrol.com.
  4. Web site: Aurobindo Pharma Limited Annual Report 2016-17 . https://web.archive.org/web/20220121001625/https://aurobindo.com/docs/annual-reports/aurobindo-ar-2016-17.pdf . 21 January 2022 . dead.
  5. Web site: Aurobindo Pharma Ltd: Company Overview, History, Contacts Brand India Pharma. www.brandindiapharma.in. 2019-10-15.
  6. http://articles.economictimes.indiatimes.com/2010-09-06/news/27603805_1_aurobindo-pharma-dosage-and-sterile-products-uk-mhra "Aurobindo Pharma signs supply pact with AstraZeneca"
  7. http://articles.economictimes.indiatimes.com/2010-11-05/news/27598030_1_net-profit-aurobindo-pharma-forex-gains "Pfizer, Astra deals to drive Aurobindo Pharma's growth"
  8. Web site: Know 10 largest Pharmaceutical Companies in India . 2023-07-28 . Edu Dwar. 12 January 2023 .
  9. News: paper . 15 February 2014 . 34 . 4 . 10 . . Aurobindo Buys Actavis' European Operations . News: Industry Watch .
  10. News: Aurobindo To Buyout Actavis' EU Ops. 20 January 2014. Bloomberg TV India.
  11. News: Aurobindo Pharma to focus on high-value products in US . 12 January 2018 . Business Line . G Naga . Sridhar . 6 January 2019.
  12. Web site: PTI. 2017-01-07. Aurobindo Pharma to acquire Portugal's Generis for €135 million. 2021-04-12. mint. en.
  13. Web site: Trivedi. Isha. 2017-02-10. Aurobindo Pharma buys 4 biosimilar products from TL Biopharmaceutical. 2021-04-12. mint. en.
  14. Web site: Limited. Aurobindo Pharma. Aurobindo Signs a Definitive Agreement to Acquire Apotex' Businesses in Poland, Czech Republic, the Netherlands, Spain and Belgium. 2021-04-12. PR Newswire. en.
  15. Web site: Aurobindo arm TheraNym inks pact with MSD for biologics manufacturing. 2024-06-01. Business Standard.
  16. News: Thomas . Katie . 20 States Accuse Generic Drug Companies of Price Fixing . . 2016-12-15 . 2016-12-16 .
  17. Web site: 'Manufacturer of Dutch medicines exploit workers and pollute the environment' - Zembla - BNNVARA. 2021-04-12. Zembla. nl.
  18. Web site: Research. Center for Drug Evaluation and. 2019-07-02. Aurobindo Pharma Limited - 577033 - 06/20/2019. 2021-04-12. Center for Drug Evaluation and Research. en.
  19. News: Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDA. 2019-10-10. The Economic Times. 2019-10-15.
  20. Web site: Aurobindo Pharma share crashes 20% to hit 52-week low on USFDA observations; Lupin, Glenmark fall up to 9%. businesstoday.in. 7 October 2019 . 2019-10-15.
  21. Web site: Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity . . 31 December 2018 . Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification..
  22. Web site: AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity . . 1 March 2019 . AurobindoPharma USA, Inc. and Acetris Health LLC. Are conducting a voluntary recall expansion of 39 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification..
  23. Web site: Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity . U.S. Food and Drug Administration (FDA) . 6 November 2019 . https://web.archive.org/web/20191111033706/https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-38-lots-ranitidine . 11 November 2019 . live . 10 November 2019 . Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in the finished product. The impurity detected is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification..

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