NDMA in Ranitidine: Understanding the Controversy and Taj Pharma’s Response

NDMA in Ranitidine: Understanding the Controversy and Taj Pharma’s Response

Ranitidine is commonly prescribed medicine for countering acidity holds a significant place on the WHO’s Model List of Essential Medicines. However, it found itself at the center of a raging controversy due to the presence of NDMA or N-Nitrosodimethylamine—a probable cancer-causing substance. Let’s delve into the controversy and Taj Pharmaceuticals’ response.

The NDMA Scare

On September 29, 2019, the US FDA raised a global alarm regarding the presence of NDMA in some Ranitidine medicines. This revelation sent shockwaves through the pharmaceutical industry and prompted companies to take swift action.

Taj Pharmaceuticals, a Mumbai-based pharmaceutical company, was not exempt from these concerns. They suspended the manufacturing and sale of Ranitidine following worries about the cancer-causing impurity, N-nitrosodimethylanine (NDMA).

Taj Pharma’s Reassurance

However, Taj Pharmaceuticals swiftly responded to the crisis with a comprehensive approach. They conducted an extensive NDMA Risk Assessment Report, employing advanced methods for analyzing Ranitidine Hydrochloride. The results were promising—NDMA formation in their Ranitidine Hydrochloride was found to be negligible.

In a statement, Taj Pharmaceuticals affirmed their commitment to safety: “The Company intends to provide additional updates in the next coming days, including potential recommencement.”

FDA’s Perspective

As the controversy unfolded, both the US and European Union regulators launched investigations into the presence of NDMA in branded and generic Zantac, the brand name for Ranitidine. However, the U.S. drug regulator later downplayed the risk, stating that their tests suggested that Ranitidine did not cause carcinogens.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, added a reassuring note: “The levels of the probable carcinogen N-nitrosodimethylamine (NDMA) found in Ranitidine are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”

The Wider Context

Ranitidine’s significance in healthcare cannot be understated. It’s a commonly prescribed medicine, and it holds a place on the World Health Organization’s Model List of Essential Medicines. In India alone, numerous pharmaceutical companies offer over 180 versions of this drug.

The market size for the Ranitidine brand in India is substantial, standing at Rs 688.6 crore, as per data shared by AIOCD PharmaTrac.

Taj Pharmaceuticals: Leading the Way

Taj Pharmaceuticals is not just another pharmaceutical company. It’s a global leader in generics and one of India’s top ten pharmaceutical firms. Their expertise spans therapeutic areas such as cancer, virology, and transplantation.

What sets Taj Pharma apart is their commitment to individualized healthcare solutions. They aim to reduce suffering and improve the quality of life for people worldwide. With a century-long legacy, Taj Pharmaceuticals is dedicated to translating a great vision into reality—innovating healthcare.

In conclusion, while the NDMA controversy rocked the pharmaceutical world, Taj Pharmaceuticals’ commitment to safety and transparency shines through. Ranitidine remains an essential medicine in the fight against acidity, and with companies like Taj Pharma leading the way, patients can continue to rely on this vital medication.

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About Taj Pharma

Taj Pharmaceuticals is the global leader in generics and one of India’s top ten pharmaceutical companies. Taj Pharma India plays a leading role in therapeutic areas such as cancer, virology, and transplantation. Their combined strengths in generics and pharmaceuticals, along with expertise in emerging genetic sciences, equip them to develop integrated healthcare solutions tailored to individual patients’ needs.

Taj Pharmaceuticals India delivers a unique contribution to better healthcare. Their vision is to develop targeted medicines and diagnostic tools that offer patients, physicians, and payers better, safer, and more cost-effective healthcare.

Welcome to Taj Pharmaceuticals, a company translating a great vision into reality—We Innovate Healthcare.