Aurobindo Pharma

Aurobindo Pharma Limited is a pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s area of activity includes six major therapeutic/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.[5] Its marketing partners include AstraZeneca[6] and Pfizer.[7]

Aurobindo Pharma Limited
TypePublic
NSE: AUROPHARMA
BSE: 524804
IndustryPharmaceuticals
Founded1986
FoundersV. Ramprasad Reddy[1]
K. Nityananda Reddy[1]
HeadquartersHyderabad, Telangana, India
Products
Revenue ₹23,290 crore (US$3.3 billion) (2020)[3]
₹4,063 crore (US$570 million) (2020)[3]
₹2,844 crore (US$400 million) (2020)[3]
Total assets ₹28,926 crore (US$4.1 billion) (2020)[3]
Total equity ₹16,751 crore (US$2.3 billion) (2020)[3]
Number of employees
23,000[4] (2020)
Websitewww.aurobindo.com

Company

The company commenced operations in 1988–89 with a single unit manufacturing semi-synthetic penicillin (SSP) in Puducherry. 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.[5] Aurobindo exports to over 125 countries across the globe 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.[8][9]

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 generic penetration in these countries is low.[10]

In 2017, Aurobindo Pharma inked a pact to acquire Portugal’s Generis Farmaceutica SA from Magnum Capital Partners for a consideration of €135 million.[11] It also acquired four biosimilar products from Swiss firm TL Biopharmaceutical AG.[12]

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.[13]

In December 2016, the attorneys general of 20 states 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.[14]

On 11 April 2018, Aurobindo was featured in the Dutch documentary television program Zembla.[15] 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 United States Food & Drug Administration after inspecting its drug manufacturing facility, Aurobindo Pharma Limited in Pydibhimavaram, Ranasthalam (Mandal), Srikakulam District, AP.[16] The warning letter summarized significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).

On October 7, 2019 Aurobindo said it received seven observations from the US health regulator for its unit-7 formulation plant in Telangana, with regard to potentially misleading documentation.[17] This caused its share prices to drop over 20%.[18]

Recalls
See also: Valsartan § recalls, and Angiotensin II receptor blocker § recalls

In 2018,[19] and 2019,[20] 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 some lots of ranitidine tablets, capsules, and syrup due to the detection of unacceptable levels of N-nitrosodimethylamine (NDMA).[21]

See also

References
  1. https://www.aurobindo.com/about-us/
  2. https://www.aurobindo.com/wp-content/uploads/2020/08/Aurobindo-Pharma-Limited-Annual-Report-2019-20.pdf
  3. "Aurobindo Pharma Ltd. Financial Statements". moneycontrol.com.
  4. http://www.aurobindo.com/docs/annual-reports/aurobindo-ar-2016-17.pdf
  5. "Aurobindo Pharma Ltd: Company Overview, History, Contacts | Brand India Pharma". www.brandindiapharma.in. Retrieved 15 October 2019.
  6. "Aurobindo Pharma signs supply pact with AstraZeneca", Economic Times, 6 September 2010
  7. "Pfizer, Astra deals to drive Aurobindo Pharma’s growth", Economic Times, 5 November 2010
  8. "Aurobindo Buys Actavis' European Operations". News: Industry Watch. Gen. Eng. Biotechnol. News (paper). 34 (4). 15 February 2014. p. 10.
  9. "Aurobindo To Buyout Actavis' EU Ops". Bloomberg TV India. Retrieved 20 January 2014.
  10. Sridhar, G Naga (12 January 2018). "Aurobindo Pharma to focus on high-value products in US". The Hindu Business Line. Retrieved 6 January 2019.
  11. http://www.livemint.com/Companies/lv3KqcJ8s1e5hn68BKyfEO/Aurobindo-Pharma-to-acquire-Portugals-Generis-for-135-mill.html
  12. http://www.livemint.com/Companies/HeABAdTWeZEUHYDmNMxzcJ/Aurobindo-Pharma-buys-4-biosimilar-products-from-TL-Biopharm.html
  13. https://www.prnewswire.com/news-releases/aurobindo-signs-a-definitive-agreement-to-acquire-apotex-businesses-in-poland-czech-republic-the-netherlands-spain-and-belgium-808992512.html
  14. Thomas, Katie (15 December 2016). "20 States Accuse Generic Drug Companies of Price Fixing". The New York Times. Retrieved 16 December 2016.
  15. https://zembla.bnnvara.nl/nieuws/manufacturer-of-dutch-medicines-exploit-workers-and-pollute-the-environment
  16. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharma-limited-577033-06202019
  17. "Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDA". The Economic Times. 10 October 2019. Retrieved 15 October 2019.
  18. "Aurobindo Pharma share crashes 20% to hit 52-week low on USFDA observations; Lupin, Glenmark fall up to 9%". www.businesstoday.in. Retrieved 15 October 2019.
  19. "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. This article incorporates text from this source, which is in the public domain.
  20. "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. This article incorporates text from this source, which is in the public domain.
  21. "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. Archived from the original on 11 November 2019. Retrieved 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. This article incorporates text from this source, which is in the public domain.
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