The Ministry of Food and Drug Safety and pharmaceutical companies are paying keen attention to detecting carcinogens in hypertension medicines with the atenolol ingredient.

According to industry sources, regulatory authorities recently detected N-Nitroso-Atenolol, a cancer-causing substance, in hypertension treatments made in Korea using Indian raw materials.

In response, Shin Poong Pharm requested medical institutions to suspend the prescription of its Shin Poong Atenolol Tab.

Tension is rising, especially because the N-Nitro-Atenolol detected recently is N-Nitrosodimethylamine (NDMA), one of the nitrosamine impurities which can cause cancer.

The domestic pharmaceutical industry experienced great confusion when they detected NDMA in hypertension treatment substance valsartan and antiulcer components ranitidine and nizatidine.

In 2021, they detected azido impurities in losartan-based hypertension drugs and N-Nitroso aryl Pipierazine (NNAP) in quetiapine-based schizophrenia treatments, causing controversy about their quality and safety.

The ministry has yet to take follow-up steps after demanding material suppliers and end product makers to submit the data of tests and examinations.

The daily intake allowance of NDMA disclosed by the ministry on Dec. 19 is 96 ng. However, it was set by a drugmaker, Whawon Pharm, and the ministry has been managing the intake allowance according to this criterion until it prepares a separate one.

“We are collecting data from related companies to make a unified approach. We are thinking about which step to take and when,” a ministry official said.

There are 32 domestic drugmakers with brands containing N-Nitroso-Atenolol ingredients.

They include Daewoo Pharm, Daewoong Bio, Daewoong Pharmaceutical, Ildong Pharmaceutical, Samnam Pharm, Medica Korea, SamChunDang Pharm, Sinil Pharm, Shinpoong Pharmaceutical, CMG Pharmaceutical, TDS Pharm, Korea Prime Pharm, Theragen Etex, Sungwon Adcock Pharm, Genuonesciences, KyungDong Pharm, Ahngook Pharm, Alpha Pharm, Samjin Pharm, Mirae Pharm, Yungjin Pharm, Iksu Pharm, Withus Pharm, Reyon Pharm, Joonghun Pharmaceutical, GL Pharma, KMS Pharm, Myungmoon Pharm, Alvogen Korea, Hana Pharm, and Hanmi Pharm.

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