Metformin Hydrochloride

SUN PHARMACEUTICAL INDUSTRIES INC initiated a Class II recall of RIOMET ER (metformin hydrochloride) due to N-nitrosodimethylamine (NDMA) impurity. This terminated recall, impacting 747 bottles, underscores critical cGMP deviations and ongoing nitrosamine risks. Procurement and regulatory teams must enhance supplier scrutiny and diversify sourcing to mitigate supply chain vulnerabilities.

ScieGen Pharms has secured multiple approvals for its Abbreviated New Drug Application (ANDA203769) for generic Metformin Hydrochloride tablets, including original market entry in 2013 and subsequent manufacturing and labeling updates through 2020. This reinforces the competitive landscape for this essential oral antidiabetic, offering procurement directors diversified supply options across various strengths. Regulatory affairs teams should note the ongoing lifecycle management demonstrated by these approvals.