Ranitidine was introduced in 1981 and became the world's biggest-selling prescription drug by 1987.

Zantac, a popular drug for treating heartburn and acid reflux, was first introduced to the market in 1983.

By 1988, Zantac had become the world's best-selling drug, used for treating ulcers, heartburn, and gastroesophageal reflux disease (GERD), with a significant impact on the pharmaceutical market.

In 1996, Zantac was approved for over-the-counter use, leading to its availability as a generic drug the following year.

In 1997, the patent for ranitidine, the active ingredient in Zantac, expired, leading to the emergence of numerous affordable generic brands of ranitidine in the market.

Zantac's original patent expired in 2001, leading to the availability of generic options and a complex supply chain.

In 2006, Boehringer acquired the U.S. rights to over-the-counter Zantac and sold it until 2016.

A 2011 study revealed that ranitidine had the strongest potential to form N-nitrosodimethylamine (NDMA) among pharmaceuticals during chloramine disinfection in drinking water.

A 2016 study demonstrated that ranitidine produced NDMA in a laboratory setting simulating human digestion, raising concerns about the risks associated with chronic consumption.

In September 2019, Valisure, an online pharmacy and accredited laboratory, filed a detailed Citizen Petition with the U.S. Food & Drug Administration (FDA) requesting the recall of all ranitidine products due to the presence of NDMA.

On September 13, 2019, the FDA issued a statement alerting patients and healthcare professionals about the presence of NDMA in samples of ranitidine, including Zantac, leading to concerns about contamination.

In October 2019, Sanofi recalled all over-the-counter Zantac products in the U.S. following FDA testing results that indicated potential NDMA contamination, raising further alarms.

On April 1, 2020, the FDA made a request for all Ranitidine (Zantac) products to be removed from the market due to ongoing concerns about NDMA contamination, marking a significant development in the Zantac timeline.

On July 1, 2021, Solara Active Pharma Sciences announced successful risk mitigation for NDMA formation during ranitidine API production, receiving certification from the European Directorate for the Quality of Medicines and Healthcare.