Daewoong Pharmaceutical Confirms No Detection of 'Azido Impurity' in Olmesartan

Ollomax (Photo by Daewoong Pharmaceutical)

[Asia Economy Reporter Kim Ji-hee] Daewoong Pharmaceutical and Korea Daiichi Sankyo announced on the 29th that after conducting detailed inspections on a total of 21 finished pharmaceutical products of the olmesartan class antihypertensive drugs handled by both companies, azido impurity (AZBT) was not detected.

This investigation follows the Canadian Federal Health Department's recall of certain sartan class antihypertensive drugs in May due to excessive detection of AZBT. In June, the Korean Ministry of Food and Drug Safety requested an analysis and evaluation of the possibility of AZBT occurrence. AZBT is classified as a hazardous substance that can cause genetic mutations in the human body.

Daewoong Pharmaceutical and Korea Daiichi Sankyo conducted an investigation on 21 finished pharmaceutical products containing olmesartan medoxomil as the main ingredient and confirmed no abnormalities. The investigation included Sevikar® tablets and Sevikar HCT® tablets imported by Korea Daiichi Sankyo and sold by Daewoong Pharmaceutical, as well as Olmetec® tablets, Olmetec Plus® tablets, Olomax® tablets, and Olosta® tablets manufactured and sold by Daewoong Pharmaceutical.

Daewoong Pharmaceutical established an analysis method using liquid chromatography-mass spectrometry (LC-MS) capable of detecting amounts as low as 1 μg/g, which is much lower than the provisional control standard of AZBT at 37.5 μg/g. They also artificially exposed raw materials and finished products to heat and light before testing to consider the possibility of AZBT decomposition or generation. As a result, AZBT was not detected in any of the tested pharmaceutical products.

Korea Daiichi Sankyo reviewed the possibility of AZBT occurrence throughout the entire manufacturing process at overseas manufacturing sites of olmesartan medoxomil raw materials supplied domestically. It was confirmed that AZBT was not detected in the final stage of the process. Finished pharmaceutical products were found to have no possibility of AZBT occurrence during the manufacturing process.

Park Eun-kyung, Head of ETC Marketing at Daewoong Pharmaceutical, stated, “Although olmesartan class drugs from Daewoong Pharmaceutical and Daiichi Sankyo were not originally subject to measured value submission inspections, we conducted independent tests to ensure safety as we believed it could cause anxiety among medical staff and patients. We will continue to cooperate to comply with more stringent systems in pharmaceutical quality control and production processes.”

Yang Hyun-joo, Head of Development Medical at Korea Daiichi Sankyo, said, “The olmesartan family based on olmesartan consists of domestic representative ARB class antihypertensive drug lineups jointly sold by Korea Daiichi Sankyo and Daewoong Pharmaceutical or independently developed by Daewoong Pharmaceutical. Through thorough inspections of raw materials and finished pharmaceutical products, it has been confirmed that there are no quality issues with olmesartan class antihypertensive drugs. We hope that medical staff and patients can prescribe and take these drugs with confidence, enabling patients to manage their blood pressure stably.”