>Valenciano since there are about 197 countries, where else would these countries be, if not "across the globe" ? |
typo fix |
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{{Short description|Indian multinational pharmaceutical company}} | {{Short description|Indian multinational pharmaceutical company}} | ||
{{More citations needed|date=February 2017}} | |||
{{Use dmy dates|date=January 2019}} | {{Use dmy dates|date=January 2019}} | ||
{{Use Indian English|date=January 2019}} | {{Use Indian English|date=January 2019}} | ||
{{Infobox company | {{Infobox company | ||
| name = Aurobindo Pharma Limited | | name = Aurobindo Pharma Limited | ||
| Line 21: | Line 21: | ||
| traded_as = {{NSE|AUROPHARMA }}<br />{{BSE|524804}} | | traded_as = {{NSE|AUROPHARMA }}<br />{{BSE|524804}} | ||
| ISIN = | | ISIN = | ||
| industry | | industry = [[Pharmaceutical industry|Pharmaceuticals]] | ||
| products | | products = {{hlist|[[Pharmaceutical]]s |[[generic drug]]s |[[over-the-counter drug]]s |[[vaccine]]s |[[Medical diagnosis|diagnostics]] |[[contact lens]]es |[[Veterinary medicine|animal health]]<ref>{{ cite web |url=https://www.aurobindo.com/wp-content/uploads/2020/08/Aurobindo-Pharma-Limited-Annual-Report-2019-20.pdf |title=Aurobindo Pharma Limited Annual Report 2019-20 |archive-url=https://web.archive.org/web/20200813125147/https://www.aurobindo.com/wp-content/uploads/2020/08/Aurobindo-Pharma-Limited-Annual-Report-2019-20.pdf |archive-date=2020-08-13 |url-status=dead}}</ref> }} | ||
| fate = | | fate = | ||
| predecessor = <!-- or: | predecessors = --> | | predecessor = <!-- or: | predecessors = --> | ||
| successor = <!-- or: | successors = --> | | successor = <!-- or: | successors = --> | ||
| founded = 1986 <!-- if known: {{start date|df=yes|YYYY|MM|DD}} in [[city]], [[country]] --> | | founded = {{Start date and age|1986}} <!-- if known: {{start date|df=yes|YYYY|MM|DD}} in [[city]], [[country]] --> | ||
| founders = V. Ramprasad Reddy<ref name="Auro_01"/><br />K. Nityananda Reddy<ref name="Auro_01">https://www.aurobindo.com/about-us/</ref> | | founders = V. Ramprasad Reddy<ref name="Auro_01"/><br />K. Nityananda Reddy<ref name="Auro_01">{{cite web| url=https://www.aurobindo.com/about-us/ | title=Aurobindo Overview}}</ref> | ||
| defunct = <!-- {{end date|df=yes|YYYY|MM|DD}} --> | | defunct = <!-- {{end date|df=yes|YYYY|MM|DD}} --> | ||
| hq_location = [[ | | hq_location = [[Hyderabad]], [[Telangana]], India | ||
| hq_location_city = | | hq_location_city = | ||
| hq_location_country = | | hq_location_country = | ||
| Line 39: | Line 39: | ||
| production_year = <!-- Year of production data (when known) --> | | production_year = <!-- Year of production data (when known) --> | ||
| services = | | services = | ||
| revenue = {{increase}} {{INRConvert| | | revenue = {{increase}} {{INRConvert|31724|c}} (2025) | ||
| operating_income = {{increase}} {{INRConvert| | | operating_income = {{increase}} {{INRConvert|6605|c}} (2025) | ||
| net_income = {{increase}} {{INRConvert| | | net_income = {{increase}} {{INRConvert|3484|c}} (2025) | ||
| assets = {{increase}} {{INRConvert| | | assets = {{increase}} {{INRConvert|49748|c}} (2025) | ||
| equity = {{increase}} {{INRConvert| | | equity = {{increase}} {{INRConvert|32646|c}} (2025) | ||
| owner = <!-- or: | owners = --> | | owner = <!-- or: | owners = --> | ||
| members = | | members = | ||
| members_year = <!-- Year of members data (when known) --> | | members_year = <!-- Year of members data (when known) --> | ||
| num_employees = 23,000<ref>http://www.aurobindo.com/docs/annual-reports/aurobindo-ar-2016-17.pdf</ref> | | num_employees = 23,000<ref>{{cite web |url=http://www.aurobindo.com/docs/annual-reports/aurobindo-ar-2016-17.pdf |title=Aurobindo Pharma Limited Annual Report 2016-17 |archive-url=https://web.archive.org/web/20220121001625/https://aurobindo.com/docs/annual-reports/aurobindo-ar-2016-17.pdf |archive-date=21 January 2022 |url-status=dead}}</ref> | ||
| num_employees_year = 2020<!-- Year of num_employees data (when known) --> | | num_employees_year = 2020<!-- Year of num_employees data (when known) --> | ||
| parent = | | parent = | ||
| Line 55: | Line 55: | ||
| ratio = <!-- Basel III ratio, for BANKS ONLY --> | | ratio = <!-- Basel III ratio, for BANKS ONLY --> | ||
| rating = <!-- credit rating, for BANKS ONLY --> | | rating = <!-- credit rating, for BANKS ONLY --> | ||
| website = {{URL|http://www.aurobindo.com/}} | | website = {{URL|http://www.aurobindo.com/}} | ||
| footnotes = Financials {{as of|2025|03|31|lc=y|df=yes}}.<ref>{{cite web |title=Audited consolidated financial results for year ended March 31, 2025 |url=https://www.aurobindo.com/api/uploads/resultsannouncement/LtrToSEsOutcomeofBM26052025.pdf |publisher=Aurobindo Pharma |access-date=27 May 2025}}</ref> | |||
}} | }} | ||
'''Aurobindo Pharma Limited''' is | '''Aurobindo Pharma Limited''' is an Indian multinational [[pharmaceutical]] manufacturing company based in [[HITEC City]], [[Hyderabad]], with U.S. [[headquarters]] in [[East Windsor, New Jersey|East Windsor]], [[Mercer County, New Jersey|Mercer County]], [[New Jersey]]. The company manufactures [[Generic drug|generic]] pharmaceuticals and [[Active ingredient|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.<ref name=":0">{{Cite web|url=https://www.brandindiapharma.in/pharmaceutical-companies-india/aurobindo-pharma-ltd|title=Aurobindo Pharma Ltd: Company Overview, History, Contacts {{!}} Brand India Pharma|website=www.brandindiapharma.in|access-date=2019-10-15}}</ref> The company markets these products in over 125 countries.<ref name=":0" /> Its marketing partners include [[Pfizer]]<ref>[https://web.archive.org/web/20140331072735/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"], ''The Economic Times'', 5 November 2010</ref> and [[AstraZeneca]]. | ||
<ref>[https://web.archive.org/web/20140331053923/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"], ''The Economic Times'', 6 September 2010</ref> | |||
==History== | |||
[[File:Clindamycin.jpg|thumb|Aurobindo Pharma [[clindamycin]] capsules]] | |||
The company commenced operations in 1988–89 with a single unit manufacturing semi-synthetic [[penicillin]] (SSP) in [[Puducherry (union territory)|Puducherry]]. Aurobindo Pharma became a [[public company]] in 1992 and listed its shares on the Indian [[stock exchange]]s in 1995. Aurobindo Pharma also has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterologicals, and cephalosporins, among others. | |||
Aurobindo Pharma features among the top 10 companies in India in terms of consolidated revenues.<ref name=":0" /> Aurobindo exports to over 125 countries with more than 70% of its revenues derived out of international operations, primarily from the U.S. | |||
Aurobindo | In 2014, Aurobindo purchased the generic operations of [[Actavis]] in seven Western European countries for US$41 million.<ref>{{cite news | type=paper | date=15 February 2014 | volume=34 | issue=4 | page=10 | work=[[Gen. Eng. Biotechnol. News]] | title=Aurobindo Buys Actavis' European Operations | department=News: Industry Watch }}</ref><ref>{{cite news|url=http://www.btvin.com/videos/watch/5197/aurobindo-to-buyout-actavis%27-eu-ops|archive-url=https://web.archive.org/web/20141024025904/http://www.btvin.com/videos/watch/5197/aurobindo-to-buyout-actavis%27-eu-ops|url-status=usurped|archive-date=24 October 2014|title=Aurobindo To Buyout Actavis' EU Ops|accessdate=20 January 2014| publisher=Bloomberg TV India}}</ref> | ||
===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.<ref>{{cite news | url=https://www.thehindubusinessline.com/companies/aurobindo-pharma-to-focus-on-highvalue-products-in-us/article9722248.ece | title=Aurobindo Pharma to focus on high-value products in US | date=12 January 2018 | newspaper=Business Line | first=G Naga | last=Sridhar | accessdate=6 January 2019}}</ref> | |||
In 2017, Aurobindo Pharma inked a pact to acquire Portugal's [[Generis Farmaceutica|Generis Farmaceutica SA]] from Magnum Capital Partners for a consideration of €135 million.<ref>{{Cite web|last=PTI|date=2017-01-07|title=Aurobindo Pharma to acquire Portugal's Generis for €135 million|url=https://www.livemint.com/Companies/lv3KqcJ8s1e5hn68BKyfEO/Aurobindo-Pharma-to-acquire-Portugals-Generis-for-135-mill.html|access-date=2021-04-12|website=mint|language=en}}</ref> It also acquired four biosimilar products from Swiss firm TL Biopharmaceutical AG.<ref>{{Cite web|last=Trivedi|first=Isha|date=2017-02-10|title=Aurobindo Pharma buys 4 biosimilar products from TL Biopharmaceutical|url=https://www.livemint.com/Companies/HeABAdTWeZEUHYDmNMxzcJ/Aurobindo-Pharma-buys-4-biosimilar-products-from-TL-Biopharm.html|access-date=2021-04-12|website=mint|language=en}}</ref> | |||
Aurobindo Pharma | |||
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.<ref>{{Cite press release|last=Limited|first=Aurobindo Pharma|title=Aurobindo Signs a Definitive Agreement to Acquire Apotex' Businesses in Poland, Czech Republic, the Netherlands, Spain and Belgium|url=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|access-date=2021-04-12|agency=PR Newswire|language=en}}</ref> | |||
Aurobindo Pharma Ltd | 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.<ref>{{Cite web |title=Aurobindo arm TheraNym inks pact with MSD for biologics manufacturing|url=https://www.business-standard.com/companies/news/aurobindo-arm-theranym-inks-pact-with-msd-for-biologics-manufacturing-124053101785_1.html|access-date=2024-06-01|work=Business Standard}}</ref> | ||
==Legal issues== | ==Legal issues== | ||
In December 2016, | In December 2016, 20 American [[State attorney general|attorneys general]] filed a [[Lawsuit|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 fixing|price collusion schemes]] between six pharmaceutical firms including informal gatherings, telephone calls, and text messages.<ref>{{cite news |last=Thomas |first=Katie |url=https://www.nytimes.com/2016/12/15/business/generic-drug-price-lawsuit-teva-mylan.html |title=20 States Accuse Generic Drug Companies of Price Fixing |work=[[The New York Times]] |date=2016-12-15 |accessdate=2016-12-16 }}</ref> | ||
On 11 April 2018, Aurobindo was featured in the Dutch documentary television program ''[[Zembla (TV series)|Zembla]]''.<ref>{{Cite web|title='Manufacturer of Dutch medicines exploit workers and pollute the environment' - Zembla - BNNVARA|url=https://www.bnnvara.nl/zembla/artikelen/manufacturer-of-dutch-medicines-exploit-workers-and-pollute-the-environment|access-date=2021-04-12|website=Zembla|language=nl}}</ref> It details accusations against the company of both environmental damage and poor working conditions for their employees in [[Hyderabad, India]]. | On 11 April 2018, Aurobindo was featured in the Dutch documentary television program ''[[Zembla (TV series)|Zembla]]''.<ref>{{Cite web|title='Manufacturer of Dutch medicines exploit workers and pollute the environment' - Zembla - BNNVARA|url=https://www.bnnvara.nl/zembla/artikelen/manufacturer-of-dutch-medicines-exploit-workers-and-pollute-the-environment|access-date=2021-04-12|website=Zembla|language=nl}}</ref> 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 [[US Food and Drug Administration]] after an inspection of its drug manufacturing facility, Aurobindo Pharma Limited in Pydibhimavaram, | On 20 June 2019, Aurobindo received a warning letter from the [[US Food and Drug Administration|USFDA]] after an inspection of its drug manufacturing facility, Aurobindo Pharma Limited in [[Pydibhimavaram]], [[Srikakulam District]], [[Andhra Pradesh]].<ref>{{Cite web|last=Research|first=Center for Drug Evaluation and|date=2019-07-02|title=Aurobindo Pharma Limited - 577033 - 06/20/2019|url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharma-limited-577033-06202019|access-date=2021-04-12|website=Center for Drug Evaluation and Research|language=en}}</ref> The warning letter summarized significant deviations from [[Good manufacturing practice|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.<ref>{{Cite news|url=https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/documents-potentially-misleading-in-aurobindo-pharmas-unit-vii-usfda/articleshow/71522222.cms|title=Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDA|date=2019-10-10|work=The Economic Times|access-date=2019-10-15}}</ref> This caused its share prices to drop over 20%.<ref>{{Cite web|url=https://www.businesstoday.in/markets/company-stock/aurobindo-pharma-share-crashes-20-to-hit-52week-low-usfda-observations-lupin-glenmark-fall-up-to-9/story/383428.html|title=Aurobindo Pharma share crashes 20% to hit 52-week low on USFDA observations; Lupin, Glenmark fall up to 9%|website= | 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.<ref>{{Cite news|url=https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/documents-potentially-misleading-in-aurobindo-pharmas-unit-vii-usfda/articleshow/71522222.cms|title=Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDA|date=2019-10-10|work=The Economic Times|access-date=2019-10-15}}</ref> This caused its share prices to drop over 20%.<ref>{{Cite web|url=https://www.businesstoday.in/markets/company-stock/aurobindo-pharma-share-crashes-20-to-hit-52week-low-usfda-observations-lupin-glenmark-fall-up-to-9/story/383428.html|title=Aurobindo Pharma share crashes 20% to hit 52-week low on USFDA observations; Lupin, Glenmark fall up to 9%|website=businesstoday.in|date=7 October 2019 |access-date=2019-10-15}}</ref> | ||
==Recalls== | ==Recalls== | ||
{{See also|Valsartan#recalls|Angiotensin II receptor blocker#recalls}} | {{See also|Valsartan#recalls|Angiotensin II receptor blocker#recalls}} | ||
In 2018,<ref name=ucm629213>{{cite web |title=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 |url=https://www.fda.gov/Safety/Recalls/ucm629213.htm |date=31 December 2018 |quote=<small>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.</small>}}{{PD-notice}}</ref> and 2019,<ref name=ucm632442>{{cite web |title=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 |url=https://www.fda.gov/Safety/Recalls/ucm632442.htm |date=1 March 2019 |quote=<small>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.</small>}}{{PD-notice}}</ref> Aurobindo Pharma USA recalled tablets containing [[valsartan]] due to the detection of [[N-Nitrosodiethylamine|''N''-Nitrosodiethylamine]] (NDEA) which is a probable human carcinogen. | In 2018,<ref name=ucm629213>{{cite web |title=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 |website=[[Food and Drug Administration]] |url=https://www.fda.gov/Safety/Recalls/ucm629213.htm |archive-url=https://web.archive.org/web/20190101134409/https://www.fda.gov/Safety/Recalls/ucm629213.htm |url-status=dead |archive-date=1 January 2019 |date=31 December 2018 |quote=<small>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.</small>}}{{PD-notice}}</ref> and 2019,<ref name=ucm632442>{{cite web |title=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 |website=[[Food and Drug Administration]] |url=https://www.fda.gov/Safety/Recalls/ucm632442.htm |date=1 March 2019 |quote=<small>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.</small>}}{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}}{{PD-notice}}</ref> Aurobindo Pharma USA recalled tablets containing [[valsartan]] due to the detection of [[N-Nitrosodiethylamine|''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).<ref>{{cite web | title=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 | website=U.S. [[Food and Drug Administration]] (FDA) | date=6 November 2019 | url=https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-38-lots-ranitidine | archive-url=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 | archive-date=11 November 2019 | url-status= | In November 2019, Aurobindo Pharma USA recalled [[ranitidine]] tablets, capsules, and syrup due to the detection of unacceptable levels of [[N-nitrosodimethylamine]] (NDMA).<ref>{{cite web | title=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 | website=U.S. [[Food and Drug Administration]] (FDA) | date=6 November 2019 | url=https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-38-lots-ranitidine | archive-url=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 | archive-date=11 November 2019 | url-status=dead | access-date=10 November 2019 | quote=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.}}{{PD-notice}}</ref> | ||
==See also== | ==See also== | ||
{{portal|Companies|India|New Jersey}} | |||
* [[Biotech and pharmaceutical companies in the New York metropolitan area]] | * [[Biotech and pharmaceutical companies in the New York metropolitan area]] | ||
{{clear}} | |||
==References== | ==References== | ||
| Line 106: | Line 113: | ||
[[Category:Pharmaceutical companies established in 1986]] | [[Category:Pharmaceutical companies established in 1986]] | ||
[[Category:Indian companies established in 1986]] | [[Category:Indian companies established in 1986]] | ||
[[Category:Manufacturing companies based in Hyderabad, India]] | [[Category:Manufacturing companies based in Hyderabad, India]] | ||
[[Category:Indian brands]] | [[Category:Indian brands]] | ||
[[Category:Generic drug manufacturers]] | [[Category:Generic drug manufacturers]] | ||
[[Category:1986 establishments in Andhra Pradesh]] | [[Category:1986 establishments in Andhra Pradesh]] | ||
[[Category:Companies listed on the National Stock Exchange of India]] | |||
[[Category:Companies listed on the Bombay Stock Exchange]] | |||
[[Category:Multinational companies headquartered in India]] | |||
Latest revision as of 14:33, 18 February 2026
 | This article needs additional citations for verification. (February 2017) |
| Aurobindo Pharma's Logo | |
| Traded as | NSE: AUROPHARMA BSE: 524804 |
|---|---|
| Industry | Pharmaceuticals |
| Founded | 1986 |
| Founder(s)s | V. Ramprasad Reddy[1] K. Nityananda Reddy[1] |
| Headquarters | Hyderabad, Telangana, India |
| Products | |
| Revenue |  ₹31,724 crore (US$4.4 billion) (2025) |
| ₹6,605 crore (US$930 million) (2025) | |
| ₹3,484 crore (US$490 million) (2025) | |
| Total assets | ₹49,748 crore (US$7.0 billion) (2025) |
| Total equity | ₹32,646 crore (US$4.6 billion) (2025) |
Number of employees | 23,000[3] (2020) |
| Website | www |
| Footnotes / references Financials as of 31 March 2025[update].[4] | |
Aurobindo Pharma Limited is an Indian multinational pharmaceutical manufacturing company based in HITEC City, Hyderabad, with U.S. headquarters in East Windsor, Mercer County, New Jersey. 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.[5] Its marketing partners include Pfizer[6] and AstraZeneca. [7]
History[edit | edit source]
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 on the Indian stock exchanges in 1995. Aurobindo Pharma also has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterologicals, 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 with more than 70% of its revenues derived out of international operations, primarily from the U.S.
In 2014, Aurobindo purchased the generic operations of Actavis in seven Western European countries for US$41 million.[8][9]
Business expansion[edit | edit source]
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.[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 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.[14]
Legal issues[edit | edit source]
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.[15]
On 11 April 2018, Aurobindo was featured in the Dutch documentary television program Zembla.[16] 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.[17] 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.[18] This caused its share prices to drop over 20%.[19]
Recalls[edit | edit source]
In 2018,[20] and 2019,[21] 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).[22]
See also[edit | edit source]
References[edit | edit source]
- ↑ 1.0 1.1 "Aurobindo Overview".
- ↑ "Aurobindo Pharma Limited Annual Report 2019-20" (PDF). Archived from the original (PDF) on 13 August 2020.
- ↑ "Aurobindo Pharma Limited Annual Report 2016-17" (PDF). Archived from the original (PDF) on 21 January 2022.
- ↑ "Audited consolidated financial results for year ended March 31, 2025" (PDF). Aurobindo Pharma. Retrieved 27 May 2025.
- ↑ 5.0 5.1 5.2 "Aurobindo Pharma Ltd: Company Overview, History, Contacts | Brand India Pharma". www.brandindiapharma.in. Retrieved 15 October 2019.
- ↑ "Pfizer, Astra deals to drive Aurobindo Pharma's growth", The Economic Times, 5 November 2010
- ↑ "Aurobindo Pharma signs supply pact with AstraZeneca", The Economic Times, 6 September 2010
- ↑ "Aurobindo Buys Actavis' European Operations". News: Industry Watch. Gen. Eng. Biotechnol. News (paper). Vol. 34, no. 4. 15 February 2014. p. 10.
- ↑ "Aurobindo To Buyout Actavis' EU Ops". Bloomberg TV India. Archived from the original on 24 October 2014. Retrieved 20 January 2014.
- ↑ Sridhar, G Naga (12 January 2018). "Aurobindo Pharma to focus on high-value products in US". Business Line. Retrieved 6 January 2019.
- ↑ PTI (7 January 2017). "Aurobindo Pharma to acquire Portugal's Generis for €135 million". mint. Retrieved 12 April 2021.
- ↑ Trivedi, Isha (10 February 2017). "Aurobindo Pharma buys 4 biosimilar products from TL Biopharmaceutical". mint. Retrieved 12 April 2021.
- ↑ Limited, Aurobindo Pharma. "Aurobindo Signs a Definitive Agreement to Acquire Apotex' Businesses in Poland, Czech Republic, the Netherlands, Spain and Belgium" (Press release). PR Newswire. Retrieved 12 April 2021.
{{cite press release}}:|last=has generic name (help) - ↑ "Aurobindo arm TheraNym inks pact with MSD for biologics manufacturing". Business Standard. Retrieved 1 June 2024.
- ↑ Thomas, Katie (15 December 2016). "20 States Accuse Generic Drug Companies of Price Fixing". The New York Times. Retrieved 16 December 2016.
- ↑ "'Manufacturer of Dutch medicines exploit workers and pollute the environment' - Zembla - BNNVARA". Zembla (in Nederlands). Retrieved 12 April 2021.
- ↑ Research, Center for Drug Evaluation and (2 July 2019). "Aurobindo Pharma Limited - 577033 - 06/20/2019". Center for Drug Evaluation and Research. Retrieved 12 April 2021.
- ↑ "Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDA". The Economic Times. 10 October 2019. Retrieved 15 October 2019.
- ↑ "Aurobindo Pharma share crashes 20% to hit 52-week low on USFDA observations; Lupin, Glenmark fall up to 9%". businesstoday.in. 7 October 2019. Retrieved 15 October 2019.
- ↑ "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". Food and Drug Administration. 31 December 2018. Archived from the original on 1 January 2019.
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.
- ↑ "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". Food and Drug Administration. 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.
[dead link] This article incorporates text from this source, which is in the public domain.
- ↑ "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.