Hetero Drugs

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Hetero Drugs Limited
Private
IndustryPharmaceuticals
Founded1993
HeadquartersHyderabad, India
Key people
Dr. Bandi Parthasaradhi Reddy
ProductsPharmaceuticals
Number of employees
Over 15,000
SubsidiariesHetero Windpower
Websitewww.heteroworld.com

Hetero Drugs Limited is an Indian pharmaceutical company established in 1993 and founded by Dr. B. Parthasaradhi Reddy.[1]

Operations[edit]

Hetero has revenues of approximately $2.0 billion.[2] Hetero group employs over 15,000 people.[3] Hetero is a player in the active pharmaceutical ingredients market and finished dosages.[4] It has marketing presence in over 100 countries.

Hetero has supplied antiretroviral drugs to patients across 125 countries.[5]

Today, Oseltamivir, sold under its brand name Tamiflu, is also indicated for A[H1N1] virus, also known as swine flu.[citation needed]

Hetero also produces hepatitis C antivirals such as Sofovir (sofosbuvir) and Ledifos (a fixed-dose combination of sofosbuvir and ledipasvir).[citation needed]

Company structure[edit]

Hetero Drugs Limited is the parent company in the Hetero group of companies and other companies which are part of the group are Hetero Labs, Hetero Research Foundation, Genx Laboratories and also foreign subsidiaries such as Camber Pharma Inc., in USA, Hetero Europe in Europe, and Richmond Labs in Argentina. The group is also investing in the wind power industry with a goal to reach 1000 megawatts by 2017.[6]

2009 flu outbreak[edit]

In 2009, as the swine flu outbreak was spreading across the globe and various health organizations and government agencies were piling up stocks of Oseltamivir as precautionary measures, Hetero supplied generic Oseltamivir under its brand name Fluvir.[7]

Hetero delivered 10 million doses of Oseltamivir to the Indian government in 2009,[8] and shipped about 80 million doses to over 60 countries.[9] Hetero received its second order from Indian government to supply another 10 million doses of Oseltamivir later in 2009.[10]

Violations of FDA regulations[edit]

In 2017, an FDA inspection of a Hetero drug manufacturing facility found several violations of cGMP regulations.[11]

In 2018[12] and 2019[13][14], losartan manufactured by Hetero Labs was recalled due to the detection of toxic impurities N-nitrosodiethylamine (NDEA)[12][13] and N-Nitroso N-Methyl 4-amino butyric acid (NMBA)[14].

References[edit]

  1. ^ "Archived copy". Archived from the original on 23 April 2012. Retrieved 6 June 2012.CS1 maint: Archived copy as title (link)
  2. ^ "Hetero Drugs Limited." n.d. Company Information, EBSCOhost (accessed 8 October 2016 via University of Arizona proxy).
  3. ^ "STADA: STADA and Indian pharmaceutical company Hetero sign letter of intent for the founding of a contractual joint venture". Stada. 26 March 2015. Retrieved 22 June 2018.
  4. ^ "Archived copy". Archived from the original on 2016-09-16. Retrieved 2016-07-11.CS1 maint: Archived copy as title (link)
  5. ^ ":: Welcome to Hetero ::". Heterodrugs.com. Archived from the original on 2014-01-17. Retrieved 2014-01-11.
  6. ^ "Hetero Windpower". Hetero. Retrieved 22 June 2018.
  7. ^ [1] Archived 30 April 2009 at the Wayback Machine
  8. ^ Khomba Singh, ET Bureau 5 May 2009, 12.03am IST (2009-05-05). "Hetero bags mega chunk of govt's anti-flu drug deal - Economic Times". Economictimes.indiatimes.com. Retrieved 2014-01-11.CS1 maint: Multiple names: authors list (link)
  9. ^ "Hyderabad pharma cos cash in on Swine-Flu fever". Moneycontrol.com. Retrieved 2014-01-11.
  10. ^ Khomba Singh, ET Bureau 22 August 2009, 03.02am IST (2009-08-22). "Hetero bags deal for 10 m Tamiflu - Economic Times". Economictimes.indiatimes.com. Retrieved 2014-01-11.CS1 maint: Multiple names: authors list (link)
  11. ^ Cosgrove, Thomas (15 August 2017). "Hetero Labs Limited Unit V 8/15/17". FDA. This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
  12. ^ a b "Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP". 2018. Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API 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.
  13. ^ a b "Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity". 2019. Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.
  14. ^ a b "Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API)". 2019. Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer). NMBA is a potential human carcinogen.