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Who Made Zantac?

Riddle Brantley LLP   |  December 8, 2021   |  

Who Made Zantac Major Zantac ManufacturersZantac was once one of the most popular heartburn medications on the market. However, after a probable human carcinogen, N-Nitrosodimethylamine (NDMA), was found in Zantac, it triggered a slew of Zantac lawsuits and a nationwide recall. Now, consumers have deep concerns about the safety of this product.

Of course, the first question on everyone’s mind is who made Zantac and who might be held responsible for any potential cancer it may have caused?

What Manufacturers Made Zantac?

Zantac is the US brand name for ranitidine. Ranitidine was discovered in 1977 by UK scientists, and since its discovery, has been manufactured under several brand names, including:

  • Zantac (US)
  • Tagamet (UK)
  • Rantac OTC (India)

GlaxoSmithKline (GSK) manufactured brand-name Zantac in the United States, as well as Tagamet in the United Kingdom. Zantac was initially developed by Pfizer as an OTC ranitidine product and was manufactured by them for many years before it was sold to Sanofi-Aventis. Sanofi was the primary manufacturer and distributor of Zantac in the US before the recall.

Who Made Generic Ranitidine?

Ranitidine is also sold in generic formats, with a wide variety of manufacturers and distributors dispensing the drug in tablets, capsules, and syrups. Some of the most notable manufacturers of generic ranitidine are:

  • GSMS Inc.
  • Mylan
  • Apotex Corp.
  • Glenmark Pharmaceutical
  • American Health Packaging
  • Sandoz Inc.
  • Reddys Laboratories Ltd.
  • Appco Pharma LLC
  • Novaritus AG

All of the above manufacturers have voluntarily recalled their ranitidine products from the shelves following the FDA’s warning, along with a dozen other manufacturers.

So, what caused so many manufacturers to recall these drugs from shelves? It all comes down to the discovery of NDMA in ranitidine products.

NDMA Contamination Discovery and Drug Recalls

In September 2019, the independent lab Valisure notified the FDA that they had detected a “concerning” amount of NDMA in ranitidine products. NDMA is classified as a “probable human carcinogen” by the FDA. This classification means that it is a substance that could potentially cause cancer in humans. Unusually high levels of it in a drug like Zantac could mean the medication is putting consumers at risk.

The FDA cited a lack of evidence for issuing a recall but began their own investigation into ranitidine products, especially Zantac. In October of 2019, the FDA confirmed that they had found “unusually high” levels of NDMA in ranitidine products and advised manufacturers to stop selling them but still did not issue an official recall.

Finally, in April of 2020, after more testing, the FDA officially requested that Zantac and all other ranitidine products no longer be sold in the United States, citing that they not only found unusually high levels of NDMA in the products, but the products could actually develop more NDMA while sitting on the shelves.

Exposure to high levels of NDMA over time can lead to a variety of cancers, including:

Unusually high levels of NDMA is correlated with an increased risk of cancer, especially if exposure occurs over a long period of time.

Once the FDA released their information on ranitidine contamination, many consumers began filing lawsuits against ranitidine manufacturers, especially Sanofi.

Zantac Lawsuits Accuse Manufacturers of Concealing Risks

Once the FDA released their findings that confirmed the presence of NDMA in Zantac and other ranitidine products, consumers began questioning whether the manufacturers were unaware of the contamination and risks associated with their products. A wave of lawsuits ensued, with many consumers accusing manufacturers like Sanofi of actively concealing the presence of NDMA in their products and its potential risks. It is important to note that defendants in Zantac lawsuits including Sanofi and GlaxoSmithKline have strongly denied any liability and/or wrongdoing, and no settlements have been agreed to.

While lawsuits against generic manufacturers have been dismissed, brand-name Zantac cases continue to move forward, with the first trial set to take place on October 10, 2022, in Oakland, California. This “bellwether” Zantac trial will likely set a precedent for subsequent Zantac cases and help determine whether or not manufacturers will have to pay out for selling consumers a product they may have known was contaminated with NDMA.

Sanofi Releases New Zantac 360 Drug 

In the wake of the controversy around ranitidine, Sanofi has released a new product, dubbed “Zantac 360.” While they may share similar names, Zantac 360 is marketed as a safe alternative and is a very different drug than original Zantac. Zantac 360 is comprised of famotidine instead of ranitidine. While both drugs are H2 blockers (they block the acid-producing cells in the stomach from creating acid), there was no trace of NDMA found in famotidine.

Zantac 360 works almost exactly like Zantac, neutralizing acid reflux and heartburn within an hour and lasting for up to twelve hours. In many studies, consumers found little difference between the two drugs in their effectiveness.

Since they are different drugs, Zantac 360 is not included in any litigation against Sanofi and Zantac.

What’s Next for Zantac Manufacturers?

With many cases pending against Sanofi, early trials and rulings will help determine whether or not Sanofi and other ranitidine manufacturers will be held liable for damage caused by carcinogens in their products, and help influence any potential Zantac settlements or compensation. Until then, ranitidine products remain off the shelves as claimants await their trials.

Do You Qualify for a Zantac Lawsuit?

Our firm is actively investigating claims that NDMA contamination in brand-name Zantac caused cancer. If you developed a qualifying cancer after taking brand-name Zantac (or a combination of the brand-name drug and generic equivalents), you may be entitled to compensation. Call 1-800-525-7111 today for a free consultation with an experienced trial attorney handling Zantac lawsuits.