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. The company markets these products in over 125 countries. Its marketing partners include AstraZeneca and Pfizer.
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. 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.
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.
In 2017, Aurobindo Pharma inked a pact to acquire Portugal’s Generis Farmaceutica SA from Magnum Capital Partners for a consideration of €135 million. It also acquired four biosimilar products from Swiss firm TL Biopharmaceutical AG.
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.
Legal issues.
In December 2016, the attorneys general of 20 US 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.
On 11 April 2018, Aurobindo was featured in the Dutch documentary television program "Zembla". 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, Ranasthalam (Mandal), Srikakulam District, AP. The warning letter summarized significant deviations from current good manufacturing practice (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. This caused its share prices to drop over 20%.
Recalls.
In 2018, and 2019, 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).