Aurobindo Pharma Limited is an Indian multinational

pharmaceutical A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...

manufacturing company headquartered in

HITEC City The Hyderabad Information Technology and Engineering Consultancy City, abbreviated as HITEC City, is an Indian information technology, engineering, health informatics, and bioinformatics, financial business district located in Hyderabad, Tela ...

Hyderabad, India Hyderabad ( ; , ) is the capital and largest city of the Indian state of Telangana and the '' de jure'' capital of Andhra Pradesh. It occupies on the Deccan Plateau along the banks of the Musi River, in the northern part of Southern Ind ...

. The company manufactures

generic Generic or generics may refer to: In business * Generic term, a common name used for a range or class of similar things not protected by trademark * Generic brand, a brand for a product that does not have an associated brand or trademark, other ...

pharmaceuticals and

active pharmaceutical ingredients An active ingredient is any ingredient that provides biologically active or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans or animals. The ...

. 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. The company markets these products in over 125 countries. Its marketing partners include

AstraZeneca AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas includi ...

and

Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfize ...

Company

The company commenced operations in 1988–89 with a single unit manufacturing semi-synthetic

penicillin Penicillins (P, PCN or PEN) are a group of β-lactam antibiotics originally obtained from '' Penicillium'' moulds, principally '' P. chrysogenum'' and '' P. rubens''. Most penicillins in clinical use are synthesised by P. chrysogenum usin ...

(SSP) in

Puducherry Puducherry or Pondicherry may refer to: * Puducherry (union territory), a union territory of India ** Pondicherry, capital of the union territory of Puducherry ** Puducherry district, a district of the union territory of Puducherry ** Puducherry t ...

. 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 Actavis Generics (formerly known as Watson Pharmaceuticals and Actavis plc, prior to the acquisition of Irish-based Allergan Inc) is a global pharmaceutical company focused on acquiring, developing, manufacturing and marketing branded pharmaceuti ...

in 7 Western European countries for $41 million.

Business expansion

Aurobindo Pharma plans to expand its product portfolio with high value products in

oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''ó ...

hormones A hormone (from the Greek participle , "setting in motion") is a class of signaling molecules in multicellular organisms that are sent to distant organs by complex biological processes to regulate physiology and behavior. Hormones are required ...

biosimilars A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved v ...

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 Poland, officially the Republic of Poland, is a country in Central Europe. It is divided into 16 administrative provinces called voivodeships, covering an area of . Poland has a population of over 38 million and is the fifth-most populou ...

Italy Italy ( it, Italia ), officially the Italian Republic, ) or the Republic of Italy, is a country in Southern Europe. It is located in the middle of the Mediterranean Sea, and its territory largely coincides with the homonymous geographical ...

Spain , image_flag = Bandera de España.svg , image_coat = Escudo de España (mazonado).svg , national_motto = '' Plus ultra'' (Latin)(English: "Further Beyond") , national_anthem = (English: "Royal March") , ...

Czech Republic The Czech Republic, or simply Czechia, is a landlocked country in Central Europe. Historically known as Bohemia, it is bordered by Austria to the south, Germany to the west, Poland to the northeast, and Slovakia to the southeast. The ...

Portugal Portugal, officially the Portuguese Republic ( pt, República Portuguesa, links=yes ), is a country whose mainland is located on the Iberian Peninsula of Southwestern Europe, and whose territory also includes the Atlantic archipelagos of th ...

and

France France (), officially the French Republic ( ), is a country primarily located in Western Europe. It also comprises of Overseas France, overseas regions and territories in the Americas and the Atlantic Ocean, Atlantic, Pacific Ocean, Pac ...

, 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 ) , anthem = ( en, "William of Nassau") , image_map = , map_caption = , subdivision_type = Sovereign state , subdivision_name = Kingdom of the Netherlands , established_title = Before independence , established_date = Spanish Netherl ...

, Spain and

Belgium Belgium, ; french: Belgique ; german: Belgien officially the Kingdom of Belgium, is a country in Northwestern Europe. The country is bordered by the Netherlands to the north, Germany to the east, Luxembourg to the southeast, France to ...

. 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 In most common law jurisdictions, the attorney general or attorney-general (sometimes abbreviated AG or Atty.-Gen) is the main legal advisor to the government. The plural is attorneys general. In some jurisdictions, attorneys general also have exe ...

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

. On 20 June 2019, Aurobindo received a warning letter from the

US Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

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).

References

External links