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Valsartan Manufacturers and Distributors

Several companies manufacture or distribute the generic blood pressure drug valsartan. Zhejiang Huahai Pharmaceutical Co. Ltd. was a large manufacturer and supplier for generic valsartan in the United States until the company announced a recall after it found a toxic impurity called N-nitrosodimethylamine (NDMA) in its valsartan in the summer of 2018. At that time several distributors, including Solco Healthcare, Teva Pharmaceuticals and Torrent Pharmaceuticals, received their valsartan from Zhejiang Huahai and were involved in the recall.

At this time, there are dozens of valsartan manufacturers and distributors in the United States. Novartis originally manufactured valsartan blood pressure medication under the brand name Diovan. The U.S. Food and Drug Administration first approved Diovan in 1996. The drug generated $5.7 billion worldwide in 2011.

After the patent expired in 2012, several generic manufacturers began making and distributing valsartan.

 

Fact
Zhejiang Huahai Pharmaceutical Co. Ltd.’s subsidiary Solco Healthcare had about 45 percent of the valsartan market prior to the recall.

In June 2018, Zhejiang Huahai Pharmaceutical Co. Ltd. and its Prinston Pharmaceuticals subsidiary informed the FDA that it had discovered N-nitrosodimethylamine (NDMA) — a known carcinogen — in its valsartan. In July 2018, the FDA announced a valsartan recall.

After the recall, people began filing valsartan lawsuits. Drugwatch’s legal partners are currently accepting cases for valsartan NDMA cancer.

Several distributors who receive their valsartan from Zhejiang Huahai and other manufacturers including Hetero Labs, Mylan and Aurobindo have recalled products.

Lawsuit Information
Several valsartan distributors are being sued by individuals who developed cancer after taking valsartan from a contaminated lot. Learn more about this pending litigation.
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Zhejiang Huahai Pharmaceuticals Co. Ltd.

Zhejiang Huahai Pharmaceuticals Logo

Zhejiang Huahai Pharmaceutical Co. Ltd. is a Chinese pharmaceutical company headquartered in Linhai City, China, and was founded in 1989. It manufactures the active ingredients for many medications including generic blood pressure medications, antidepressants, diabetes and HIV medications.

Zhejiang Huahai has been reported to be the largest supplier of “pril products” in the world. Americans know pril products as blood pressure drugs in the angiotensin-converting enzyme (ACE) inhibitor class. These include lisinopril, captopril and enalapril, among others.

Did You Know?
Zhejiang Huahai was the first Chinese company to gain FDA approval to manufacture and sell generic drugs in the United States.
Source: Zhejiang Huahai Pharmaceuticals Co. Ltd.

Zhejiang Huahai also owns Huahai U.S. Inc., Prinston Pharmaceuticals and Solco Healthcare.

Huahai US Inc.

Huahai US Inc Logo

Huahai US Inc. is Zhejiang Huahai’s American division, headquartered in Cranbury, New Jersey. The parent company founded Huahai US in 2004. In 2010, it began developing and marketing generic drugs through Prinston Pharmaceutical.

In August 2018, the company released a statement on behalf of its parent company about the valsartan recall. It disputes the speculation that NDMA may have been in the company’s valsartan since at least 2016. In fact, the FDA did not find any impurities in Zhejiang Huahai’s valsartan in previous inspections in January 2017 and September 2017, according to the statement. Inspectors did not find the NDMA impurity until June 2018.

The company said it was committed to working with regulatory agencies through the valsartan recall.

“To protect human health, recalls at the consumer level are being undertaken by the Company and its affiliates, and these will continue under the close supervision of the FDA and regulatory agencies in all affected countries,” Huahai US said in its statement.

Prinston Pharmaceutical

Prinston Pharmaceutical Inc logo

Prinston Pharmaceutical is a subsidiary of Zhejiang Huahai located in Somerset, New Jersey. It manufactured its first drug in 2010.

In addition to valsartan, it manufactures and develops the active ingredients in generic versions of several drugs, such as Lotensin, Wellbutrin SR, Lexapro, Zestril, Paxil, Risperdal. It also distributes drugs manufactured by Huahai US and Zhejiang Huahai through Solco Healthcare.

 

Recalled Valsartan Lots Distributed by Prinston Pharmaceutical and Solco Healthcare*
  • Valsartan Tablets, 40mg, 80mg, 160mg, 320mg
  • Valsartan/HCTZ 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Other Valsartan Manufacturers and Distributors in the U.S.

Novartis manufactures brand-name drugs with valsartan as the active ingredient. Their brand name valsartan products are Diovan, Diovan HCT, Entresto, Exforge and Exforge HCT. None of these products are included in the valsartan recall.

In addition to Zhejiang Huahai, other manufacturers supplied distributors with tainted valsartan.

Hetero Labs

Hetero Labs is an Indian pharmaceutical company that manufactures active ingredients for several generic drugs, including valsartan. It is the world’s largest producer of anti-retroviral drugs that treat HIV and AIDS. Camber Pharmaceuticals distributed Hetero’s valsartan products in the United States.

The FDA added products containing valsartan manufactured by Hetero in August 2018. The amount of NDMA found in Hetero’s products is less than that found in Zhejiang Huahai’s, but the company uses a similar manufacturing process.

Recalled Valsartan Manufactured by Hetero Labs and Distributed by Camber Pharmaceuticals Inc.*
  • Valsartan Tablets, 40mg, 80mg, 160mg, 320mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Mylan

Mylan is one of the largest global manufacturers of active pharmaceutical ingredients. They have more than 7500 products including over-the-counter as well as brand and generic prescription pharmaceuticals.

The FDA added products containing valsartan manufactured by Mylan in November 2018 due to the presence of N-nitrosodiethylamine (NDEA), an impurity related to NDMA.

Recalled Valsartan Manufactured by Mylan Pharmaceuticals Inc.*
  • Valsartan Tablets, 40mg, 80mg, 160mg, 320mg
  • Valsartan/HCTZ 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg
  • Amlodipine/Valsartan 5mg/160mg, 10mg/160mg, 5mg/320mg, 10mg/320mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Aurobindo Pharma

Aurobindo Pharma is an Indian pharmaceutical company exporting to over 150 countries. It is the market leader in semi-synthetic penicillin and has a number of other products in therapeutic areas such as gastroenterology, cardiology and neurology, as well as other antibiotics, antidiabetes and antiretroviral drugs.

The FDA added products containing valsartan manufactured by Aurobindo in January 2019 due to the presence of NDEA.

Recalled Valsartan Manufactured by Aurobindo Pharma Inc.*
  • Valsartan Tablets, 40mg, 80mg, 160mg, 320mg
  • Valsartan/HCTZ 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg
  • Amlodipine/Valsartan 5mg/160mg, 10mg/160mg, 5mg/320mg, 10mg/320mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Major Distributors of Tainted Valsartan in the U.S.

Aside from Solco Healthcare, other large U.S. distributors include Major Pharmaceuticals, Teva Pharmaceutical Industries and Torrent. All three companies received tainted valsartan from Zhejiang Huahai.

Major Pharmaceuticals

Major Pharmaceuticals is a large U.S. valsartan distributor founded in 1982. The company’s headquarters is located in Livonia, Michigan. It received its tainted valsartan through Teva Pharmaceuticals.

Recalled Valsartan Distributed by Major Pharmaceuticals*
  • Valsartan 80mg and 160mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Teva Pharmaceuticals

Teva Pharmaceuticals is the largest producer and distributor of generic medication worldwide. The company is headquartered in Petach Tikva, Israel. Its U.S. headquarters, Teva North America, is located in North Wales, Pennsylvania.

Did You Know?
Teva supplies one in nine of all generic prescriptions written in the United States.

It received its valsartan supply from Zhejiang Huahai. Teva said that it had not received any reports of adverse events related to the valsartan recall. These products went to several wholesalers, distributors, pharmacies and repackagers.

Recalled Valsartan Distributed by Teva Pharmaceuticals*
  • Valsartan Tablets, 40mg, 80mg, 160mg, 320mg
  • Valsartan/HCTZ 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg
  • Amlodipine/Valsartan 5mg/160mg, 10mg/160mg, 5mg/320mg, 10mg/320mg
  • Amlodipine/Valsartan/HCTZ 5mg/160mg/12.5mg, 10mg/160mg/12.5mg, 10mg/160mg/25mg, 10mg/320mg/25mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Torrent Pharmaceuticals Ltd.

Torrent Pharmaceuticals Limited is an Indian company based in Gujarat, India. It manufactures and distributes generic medications. It acquired its tainted valsartan ingredients from Zhejiang Huahai.

Recalled Valsartan Distributed by Torrent Pharmaceuticals*
  • Valsartan Tablets, 80mg, 160mg, 320mg
  • Amlodipine/Valsartan/HCTZ 5mg/160mg/12.5mg, 5mg/160mg/25mg, 10mg/160mg/12.5mg, 10mg/160mg/25mg, 10mg/320mg/25mg
  • Amlodipine/Valsartan 5mg/160mg, 10mg/160mg, 5mg/320mg, 10mg/320mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Which Valsartan Manufacturers Are Safe?

The FDA has identified valsartan products that do not contain nitrosamine contaminants. There are also many products that have not yet been tested.

Manufacturers/distributors of valsartan products that do not contain nitrosamine contaminants*
  • Accord Healthcare, Inc.
  • Alembic Pharmaceuticals Limited
  • A-S Medication Solutions, LLC
  • Amneal Pharmaceuticals, LLC
  • Aphena Pharma Solutions (repackager of valsartan and Diovan brand name)
  • Ascend Laboratories, LLC
  • AvKare, Inc.
  • Bryant Ranch Prepack
  • Glenmark Pharmaceuticals Inc., USA
  • Hisun Pharmaceuticals USA, Inc.
  • Intas Pharmaceuticals Limited
  • Jubilant Cadista Pharmaceuticals, Inc. labeled as Cadista
  • Macleods Pharmaceuticals USA
  • Northwind Pharmaceuticals
  • NuCare Pharmaceuticals
  • Ohm Laboratories, Inc.
  • Proficient Rx LP
  • RemedyRepack, Inc.
  • Sciegen Pharmaceuticals, Inc.
  • Sunshine Lake Pharma Co, LTD

*see FDA website for specific products from these companies

Please seek the advice of a medical professional before making health care decisions.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By
Medically Reviewed By

25 Cited Research Articles

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  8. FDA. (2018, July 17). Prinston Pharmaceutical Inc. Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/prinston-pharmaceutical-inc-issues-voluntary-nationwide-recall-valsartan-and-valsartan-hctz-tablets
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  11. FDA. (2018, August 23). UPDATED: ADDITIONAL LOTS ADDED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updatedadditional-lots-added-torrent-pharmaceuticals-limited-issues-voluntary-nationwide-recall
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