Communication to industry on metformin-containing medicines

Communication to industry on metformin-containing medicines

The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing the final pharmaceutical products for immediate and extended release dosage forms containing metformin hydrochloride as an active substance. This review was triggered because of the detection of an impurity, N-nitrosodimethylamine (NDMA) in the metformin hydrochloride which were observed to be above the acceptable intake limit.

2020 Oct

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File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines