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  • Safety verification data should be submitted for Metformin
  • by Lee, Tak-Sun | translator Choi HeeYoung | Jul 10, 2020 06:13am
The MFDS prepares management plan for raw materials and ingredients
Needs to attach process verification and stability data
When applying for the approval of Metformin, a diabetes treatment drug for which carcinogenic substance NDMA has been detected, additional safety verification data should be submitted in the future.

In particular, data that can prove that NDMA is not generated during the process should also be attached.

According to the industry on the 8th, the Convergence Innovation Product Support Group of the MFDS recently prepared a 'Metformin Raw Material and Containment Authorization Management Plan', and provided information through associations.

On May 26, the MFDS discontinued and recovered 31 items of Metformin in which NDMA, a carcinogenic substance, was detected excessively.

It was instructed to submit process
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