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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.[1] The company markets these products in over 125 countries.[1] Its marketing partners include Pfizer[2] and AstraZeneca. [3]
History
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.[1] 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.[4][5]
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.[6]
In 2017, Aurobindo Pharma inked a pact to acquire Portugal's Generis Farmaceutica SA from Magnum Capital Partners for a consideration of €135 million.[7] It also acquired four biosimilar products from Swiss firm TL Biopharmaceutical AG.[8]
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.[9]
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.[10]
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.[11]
On 11 April 2018, Aurobindo was featured in the Dutch documentary television program Zembla.[12] 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.[13] 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.[14] This caused its share prices to drop over 20%.[15]
Recalls
In 2018,[16] and 2019,[17] 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).[18]
See also
References
- ↑ 1.0 1.1 1.2 Aurobindo Pharma Ltd: Company Overview, History, Contacts | Brand India Pharma. www.brandindiapharma.in. Retrieved 2019-10-15.
- ↑ "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
- ↑ [{{{url}}} Aurobindo Buys Actavis' European Operations]. Gen. Eng. Biotechnol. News(15 February 2014).
- ↑ Aurobindo To Buyout Actavis' EU Ops.
- ↑ Aurobindo Pharma to focus on high-value products in US. Business Line(12 January 2018).
- ↑ Aurobindo Pharma to acquire Portugal's Generis for €135 million, PTI. mint(2017-01-07). Retrieved 2021-04-12.
- ↑ Aurobindo Pharma buys 4 biosimilar products from TL Biopharmaceutical, Trivedi, Isha. mint(2017-02-10). Retrieved 2021-04-12.
- ↑ Template:Cite press release
- ↑ Aurobindo arm TheraNym inks pact with MSD for biologics manufacturing. Retrieved 2024-06-01.
- ↑ 20 States Accuse Generic Drug Companies of Price Fixing. The New York Times(2016-12-15).
- ↑ 'Manufacturer of Dutch medicines exploit workers and pollute the environment' - Zembla - BNNVARA. Zembla. Retrieved 2021-04-12.
- ↑ Aurobindo Pharma Limited - 577033 - 06/20/2019, Research, Center for Drug Evaluation and. Center for Drug Evaluation and Research(2019-07-02). Retrieved 2021-04-12.
- ↑ Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDA. The Economic Times(2019-10-10). Retrieved 2019-10-15.
- ↑ 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 2019-10-15.
- ↑ 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).Template:PD-notice
- ↑ 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).Template:Dead linkTemplate:CbignoreTemplate:PD-notice
- ↑ 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). Retrieved 10 November 2019.Template:PD-notice