Metformin with excess NDMA was removed from the market

The MFDS temporarily suspends sales of 31 items detected in excess of NDMA in May 2020

There were no prescriptions from 19 companies, including JW Pharma and Hanall

Most of the prescriptions for 31 types of Metformin, which had been suspended for detection of excess impurities a year ago, have disappeared.

 

Sales of drugs, including Metformin, rose, but some companies were virtually kicked out from the market.

 

There are many opinions that the government should take a more careful suspension of sales.

 

According to the drug research agency UBIST on the 1st, JW Pharm's Guardmet had no outpatient prescription until May this year.

 

It posted ₩4.2 billion in prescription performance during the same period last year, but has not sold since June.

 

Guardmet is a combination of JW Pharma's DPP-4 inhibitor Guardlet(Anagliptin) and Metformin.

 

Although it emerged as JW Pharma's main product as prescription performance rose sharply to ₩5.6 billion in 2017, ₩8.2 billion in 2018, and ₩9.7 billion in 2019, all three doses, including "Guardmet" 100/500mg, 100/850mg, and 100/1000mg, disappeared from the prescription market in May last year.

 

Sales amounting to ₩10 billion a year have been lost due to unexpected detection of impurities.

 

In the case of Hanall's Glucodaun OR, the company posted a cumulative sales of ₩3.3 billion from January to May last year, but no sales this year.

 

Glucodaun OR has been temporarily suspended.

 

It recorded ₩8 billion in accumulated prescriptions in 2019.

 

The MFDS said on May 26 last year that it has temporarily suspended manufacturing and sales and imposed prescription restrictions as 31 items were found to contain excess carcinogenic N-nitrosodimethylamine (NDMA).

 

It has been about six months since the risk of impurities erupted in Singapore.

 

Singapore's Health and Science Administration (HSA) recalled three products in December 2019 on the grounds that more than NDMA was detected as a result of investigating 46 items of Metformin on sale locally.

 

The MFDS is applying the maximum daily allowance of based on NDMA 96ng provisional management standards.

 

31 items from 22 companies, which were suspended from sale at the time, accumulated ₩10.3 billion in five months from January to May last year, but only ₩800 million this year.

 

It is down 91.8% year-on-year.

 

There were no sales of 25 items except for Jeil's Lipito-M, HKinno.N's Atomet SR and Daewoong Bio's Diformin XR.

 

Products from 19 companies, including JW Pharm, Hanall and Jinyang, have virtually left the market after the impurity measures.

 

Several companies have induced prescription changes to other drugs or similar products of their own that have not been suspended from sale.

 

For example, Daewoong Bio's "Diaformin" made a prescription record of ₩25 million for five months this year.

 

Although the three capacities, Diformin XR 500 mg, Diformin XR 750 mg and Diformin XR 1000 mg, were suspended for NDMA provisional over-detection, Diformin 250 mg, Diformin 500 mg and Diformin 1000 mg products were available for sale.

 

However, compared to ₩546 million in the same period last year, the amount of prescriptions decreased 62.5% in a year.

 

In the case of Lipito-M and Atomet, only some of them were suspended, recording prescription results of more than ₩300 million and ₩100 million, respectively, this year.

 

Except for JW Pharma and Hanall, of course, the rest of the companies are not losing much.

 

Of the 31 items, Hutecs' Gluless-M and Nelson's Glutamin, which were among the top prescriptions, managed to exceed ₩200 million in cumulative prescriptions by May last year.

 

During the same period, Hanmi's Grimefol SR, Shin Poong's Dybis and Unimaryl M have less than ₩200 million in prescriptions.

 

The prescription loss is only less than ₩1 billion.

 

Metformin had little influence on the entire pharmaceutical market.

 

Last year, the prescription amount of a single metformin drug was ₩77.3 billion, up 4.1% from the previous year.

 

Considering that it increased 2.9% year-on-year in 2019, the increase was even greater.

 

Last year, the amount of prescriptions for Metformin combined with DPP-4 inhibitors was ₩458.4 billion, up 10.5% from the previous year.

 

Similarly, it rose 8.2% year-on-year.

 

Despite the spread of COVID-19 infections and the detection of impurities, there was little damage to the prescription market.

 

The reason is that discontinued products account for a small percentage of the product and that there is no drug to replace Metformin that can be prescribed for type 2 diabetics.

 

It is diagnosed that some of the learning effects of the high blood pressure treatment Valsartan, Ranitidine, and Nizatidine have been shown to have minimal harmful effects.

 

However, some say that the MFDS should be more careful in taking measures related to impurities.

 

The MFDS suspended the sale of the entire product if even one lot number of NDMA excess raw material was found for Metformin agents.

 

They say they will allow sales if the problematic product is recovered and proven suitable for carcinogens by lot numbers.

 

However, it has been a year since the temporary suspension of sales, but it is confirmed that no companies have attempted to sell them.

 

Due to the characteristics of generics, it is recognized that it will be kicked out of the market once it is suspended.

 

They say that the unexpected detection of impurities and suspension of sales during manufacturing process are damaging pharmaceutical companies.

 

An official from the pharmaceutical industry said, "In the U.S., in the case of Valsartan and Ranitidine, only the lot numbers that used impurities detection raw materials were recovered.

 

they did not suspend sales of the entire item," He said.

 

"We need to be more careful about temporary sales suspension measures due to the detection of impurities."