Year : 2021 | Volume
: 12 | Issue : 2 | Page : 120--127
Nitrosodimethylamine impurities in metformin drug products: Physician insight
Chetan Doshi, Rajkumar Malayandi, Gajanan Namjoshi, Pramod Kadam, Dhananjay Mule
Department of Clinical Research, Research and Development, USV Private Ltd, Mumbai, Maharashtra, India
Metformin is a high-dose antidiabetic drug and most widely used first-line therapeutic agent for the management of type 2 diabetes mellitus (T2DM). Medicines regulatory agencies discovered contamination of genotoxic nitrosamine impurity in certain medications containing angiotensin receptor blocking (ARB) agents. This resulted in screening for nitrosamine impurities in a number of probable drug products. In November 2019, the Singapore government withdrew metformin drug products, due to the contamination of nitrosamine impurity, called nitrosodimethylamine (NDMA). The regulatory agencies from different geographies started investigation and subsequently, many products withdrew from the international market due to the presence of an unacceptable limit of NDMA in metformin tablets. Both pharmaceutical companies and regulatory agencies responded to mitigate this emerging issue. USV Private Limited (USV) has adopted a proactive quality risk management program to investigate the presence of genotoxic impurities in metformin products. The presence of NDMA impurities were tested in 425 batches of drug substances and drug products. Threshold toxicological concern (TTC) of all the batches was found to be ≤30 ng/day, when compared to the regulatory limit of 96 ng/day. Hence, USV metformin products are safe and can be continuously prescribed for the management of T2DM.
Dr. Chetan Doshi
USV Private Ltd, Arvind Vithal Gandhi Chowk, BSD Marg, Govandi, Mumbai 400088, Maharashtra.
|How to cite this article:|
Doshi C, Malayandi R, Namjoshi G, Kadam P, Mule D. Nitrosodimethylamine impurities in metformin drug products: Physician insight.J Diabetol 2021;12:120-127
|How to cite this URL:|
Doshi C, Malayandi R, Namjoshi G, Kadam P, Mule D. Nitrosodimethylamine impurities in metformin drug products: Physician insight. J Diabetol [serial online] 2021 [cited 2021 Apr 20 ];12:120-127
Available from: https://www.journalofdiabetology.org/article.asp?issn=2078-7685;year=2021;volume=12;issue=2;spage=120;epage=127;aulast=Doshi;type=0