27 Jan Communication to industry on metformin-containing medicines
Posted at 08:17h
in
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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Document Number:
2.19
Version:
1
Date Updated:
22/10/2020
File Type:
pdf
Category:
Communication to industry