Investigation of raw materials for Metformin in Singapore

No imports history of Singapore NDMA-detected Metformin

Verifying whether the drug substance is imported in Korea

The three Metformin products recovered from Singapore have yet to be imported in Korea.

 

The Singapore Ministry of Health (HSA) recently surveyed 46 locally Metformin products and recovered three of them.

 

N-nitrosodimethylamine (NDMA) was detected above the daily allowance (96 nanograms), explains the HSA.

 

Two controversial companies are Glorious Dexa and harmazen Medical Pte Ltd.

 

Recovery targets are Glorious’ Glucient XR Tablet 500mg and Pharmazen's Meijumet Prolonged Release Tablet 750mg and 1000mg.

 

In the case of Pharmazen Medical Pte Ltd, the products produced in all batches are subject to recovery.

 

However, the Singapore Ministry of Health does not specifically explain the level or cause of detection.

 

NDMA detection Metformin products released by the Ministry of Health of Singapore.

 

It is confirmed that there are no imports of this drug in Korea

NDMA detection Metformin products released by the Ministry of Health of Singapore.

 

It is confirmed that there are no imports of this drug in Korea At present, there is no record of domestic imports of such drugs as confirmed by the Ministry of Food and Drug Safety.

 

However, the drug substance of the finished drug is not confirmed.

 

In other words, the possibility of domestic products using the same drug substance is not completely excluded.

 

An official from the Food and Drug Administration said, “If the drug has imported in Korea, it is required to register the drug, but all three items have not been imported and ewe should contact Singapore directly, the drug substance company should be identified as early as Monday”.

 

The U.S.

 

Food and Drug Administration (FDA) and the European Medicines Agency (EMA) today announced that they will begin an NDMA test for Metformin preparations on Monday (local time).

 

The direct reason is Singapore’s issue.

 

The Singapore Health Department announced the recovery of three Metformin items four days earlier.