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Valsartan Manufacturers and Distributors

Several companies manufacture or distribute the generic blood pressure drug valsartan. Zhejiang Huahai Pharmaceutical Co. Ltd. is the largest manufacturer and supplier for generic valsartan sold in the United States. The company announced a recall after it found a toxic impurity called N-nitrosodimethylamine (NDMA) in its valsartan. Several distributors, including Solco Healthcare, Teva Pharmaceuticals and Torrent Pharmaceuticals, received their valsartan from Zhejiang Huahai and are involved in the recall.

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 2002. The drug generated $5.7 billion worldwide in 2011.

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

The largest manufacturer of valsartan is Zhejiang Huahai Pharmaceutical Co. Ltd. It supplies the majority of valsartan to the United States through Solco Healthcare, the sales and marketing division of its Prinston Pharmaceutical Inc. subsidiary.

Fact
Zhejiang Huahai Pharmaceutical Co. Ltd.’s subsidiary Solco Healthcare has about 45 percent of the valsartan market.

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 two other manufacturers — Zhejiang Tianyu and Hetero Labs — are included in the FDA’s recall.

Suffering from liver damage or cancer after taking Valsartan? Get a Free Case Review

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 founded in 1989. It manufactures the active ingredients for generic blood pressure medications, antidepressants, diabetes and HIV medications. It is one of the largest valsartan manufacturers in the world.

It is 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.

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 Pharmaceuticals is a subsidiary of Zhejiang Huahai located in Cranbury, 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 Lotnesin, Wellbutrin SR, Lexapro, Zestril, Paxil, Risperdal. It also distributes drugs manufactured by Huahai US and Zhejiang Huahai through Solco Healthcare.

Solco Healthcare US has nearly half of the valsartan market in the United States and is a subsidiary of Zhejiang Huahai and is the sales and marketing arm of Prinston Pharmaceutical.

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 and Allergan manufacture brand-name drugs with valsartan as the active ingredient in plants in Europe. Both companies have locations in the United States. Their brand name valsartan products are Diovan, Diovan HCT, Entresto, Exforge and Byvalson. Neither of these two manufacturers is included in the 2018 valsartan recall.

In addition to Zhejiang Huahai, two other manufacturers supplied distributors with tainted valsartan — Zhejiang Tianyu Pharmaceutical Co. Ltd. in China and Hetero Labs in India. So far, the FDA has not mentioned valsartan manufactured by Zhejiang Tianyu in its recall list because it supplies European countries and not the United States.

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.

Major Distributors of Tainted Valsartan in the U.S.

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

Major Pharmaceuticals

Major Pharmaceuticals is a large U.S. valsartan distributor in founded in 1982. The company’s headquarters is located in Livonia, Mich. 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, Penn.

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

It received its valsartan supply from Zhejiang Huahai. Teva said that it has 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

*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*
  • Amlodipine, Valsartan and Hydrochlorothiazide Tablets 10mg/320mg/25mg
  • Amlodipine, Valsartan and Hydrochlorothiazide Tablets 10mg/160mg/25mg
  • Amlodipine, Valsartan and Hydrochlorothiazide Tablets 5mg/160mg/12.5mg
  • Amlodipine, Valsartan and Hydrochlorothiazide Tablets 10mg/160mg/12.5mg
  • Amlodipine, Valsartan and Hydrochlorothiazide Tablets 5mg/160mg/25mg
  • Amlodipine, Valsartan and Hydrochlorothiazide Tablets 10mg/320mg/25mg
  • Amlodipine and Valsartan Tablets 5 mg/160 mg
  • Amlodipine and Valsartan Tablets 10 mg/160 mg

*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 had identified valsartan products that are not a part of the recall. Some generic and brand-name manufacturers are on the FDA’s safe list, meaning they did not find any NDMA contamination.

Manufacturers not included in the valsartan recall include:
  • Alembic Pharmaceuticals Limited
  • Allergan Inc. (Byvalson brand)
  • American Health Packaging
  • Amneal Pharmaceuticals LLC
  • Aphena Pharma Solutions (repackager of valsartan and Diovan brand name)
  • Apotex Corp.
  • Aurobindo Pharma Limited
  • AvPAK
  • Camber Pharmaceuticals Inc.
  • Cardinal Health
  • Carilion Materials Management (Diovan brand name)
  • Gavis Pharmaceuticals LLC
  • Jubilant Cadista Pharmaceuticals Inc. labeled as Cadista
  • Lucid Pharma
  • Lupin
  • Macleods Pharmaceuticals USA
  • Mylan
  • Northwind Pharmaceuticals
  • Novartis Pharmaceuticals Corporation (Diovan, Entresto, Exforge and Exforge HCT brand names)
  • Novel Laboratories Inc.
  • Ohm Laboratories Inc.
  • Par Pharmaceutical Inc.
  • PD-Rx Pharmaceuticals Inc.
  • Preferred Pharmaceuticals Inc.
  • Proficient Rx LP
  • Sandoz Inc.
  • Teva Pharmaceuticals USA Inc.
  • Unichem Pharmaceuticals (USA) Inc.

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, vaccines 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
Kevin Connolly
Kevin Connolly Managing Editor

22 Cited Research Articles

  1. European Medicines Agency. (2018, August 20). Update on medicines containing valsartan from Zhejiang Tianyu. Retrieved from http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/08/news_detail_003008.jsp&mid=WC0b01ac058004d5c1
  2. FDA. (2018, August 8). Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API). Retrieved from https://www.fda.gov/Safety/Recalls/ucm616405.htm
  3. FDA. (2018, July 13). Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA). Retrieved from https://www.fda.gov/safety/recalls/ucm613625.htm
  4. 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/ucm613504.htm
  5. FDA. (2018, July 17). Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets. Retrieved from https://www.fda.gov/safety/recalls/ucm613729.htm
  6. 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/ucm617821.htm
  7. Hetero Labs. (n.d.). Profile. Retrieved from https://www.heteroworld.com/company-profile.php
  8. Huahai US, Inc. (n.d.). About Us. Retrieved from https://www.huahaius.com/index.html
  9. Husten, L. (2012, September 25). Another One Bites the Dust: Diovan Patent Expires But Generic Valsartan Is MIA. Retrieved from https://www.forbes.com/sites/larryhusten/2012/09/25/another-one-bites-the-dust-diovan-patent-expires-but-generic-valsartan-is-mia/#1cdd8d5b2833
  10. Kaplan, S. (2018, July 16). Blood Pressure Medicine Is Recalled. Retrieved from https://www.nytimes.com/2018/07/16/health/fda-blood-pressure-valsartan.html
  11. Edney, A. (2018, August 9). Red Flags Raised at Maker of Recalled Heart Drug a Year Ago. Retrieved from https://www.bloomberg.com/news/articles/2018-08-09/red-flags-raised-at-chinese-heart-drug-maker-year-before-recall
  12. Hackett, D.W. (2018, August 13). Second Chinese Pharma Included in Valsartan Recall. Retrieved from https://www.precisionvaccinations.com/zhejiang-tianyu-pharmaceutical-identified-valsartan-recall-european-medicines-agency
  13. Major Pharmaceuticals. (n.d.). About Major Pharmaceuticals. Retrieved from https://www.majorpharmaceuticals.com/about-us/
  14. Nitrosodimethylamine (NDMA) in The Products. Retrieved from https://www.fda.gov/safety/recalls/ucm613504.htm
  15. Prinston Pharmaceutical. (n.d.). About Us. Retrieved from http://www.prinstonpharm.com/index.html
  16. Solco Healthcare U.S. (n.d.). History. Retrieved from http://www.solcohealthcare.com/about-solco.html
  17. Teva Pharmaceuticals. (n.d.). Quality Medicines You Can Trust. Retrieved from https://www.tevausa.com/GenericMedicines.aspx
  18. Torrent Pharmaceuticals. (n.d.). Overview. Retrieved from http://www.torrentpharma.com/Index.php/site/info/aboutUs
  19. U.S. Food and Drugs Administration. (2018, August 31). Valsartan Products Not Currently Recalled. Retrieved from https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615704.pdf
  20. U.S. Food and Drug Administration. (2018, August 27). Valsartan Products Under Recall. Retrieved from https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf
  21. Zhejiang Huahai Pharmaceutical Co., Ltd. (n.d.). Introduction. Retrieved from http://en.huahaipharm.com/content.asp?info_kind=001002
  22. Zhejiang Huahai Pharmaceutical Co., Ltd. (2018, August 24). Update on Valsartan API – a Statement from the Company. Retrieved from http://en.huahaipharm.com/news_det.asp?ID=699&info_kind=002001
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