Once again, the fear of impurities

Pharmaceutical industry launches inspection of Azido

No relevant information, such as test methods, as a new type of impurity;

Confusion is inevitable if impurities are detected in Korea

Fear of impurities is spreading again in the domestic pharmaceutical industry.

 

There is a high risk that the aftermath of large-scale withdrawal of impurities from Canada will also damage Korea.

 

Pharmaceutical companies are nervous in that it is a new type of impurity that is different from the one that has built a verification system over the past three years.

 

◆Start investigating impurities of new types from Canada and panic because there is no test method According to the industry on the 7th, pharmaceutical companies are looking at the details of impurities of angiotensin II receptor blockers (ARB) such as Irbesartan, Losartan, and Valsartan.

 

On the 4th, the Ministry of Food and Drug Safety ordered the three ingredients to submit the results of the "Azido" impurity evaluation and test test by the 14th, and began to seek countermeasures.

 

Health Canada announced on the 31st of last month that Azido was detected in Irbesartan, Losartan and Valsartan from nine pharmaceutical companies, including Teva and Sandoz, and that voluntary recovery is underway.

 

They are large enough to reach a total of 227 lot numbers.

 

Irbesartan had 124 lot numbers, Losartan with 97 and Valsartan with 6 lot numbers.

 

Health Canada announced on the 31st of last month that Azido was detected in three ingredients of nine pharmaceutical companies: Irbesartan, Losartan, and Valsartan, and voluntary recovery is underway.

Pharmaceutical companies are very nervous in that impurities detected in Canada are new types that have not been previously found.

 

An official from a pharmaceutical company said, "We asked the supplier for data on Azido, but we are not sure if there is any." Azido is a type of carcinogenic substance in the azide family.

 

There is no known specific risk of cancer in the human body, although it may increase the risk of cancer.

 

Nitrosamines such as "NDMA" and "NDEA" have been detected in Korea since 2018, but no recovery measures have been taken due to the detection of azide-based impurities.

 

In raw materials such as Irbesartan, Losartan, and Valsartan, Azido is a harmful substance without standardization.

 

The risk of Azido detection was not recognized in advance, and there are currently no Azido impurities test methods.

 

The development is similar to that of the detection of NDMA in Valsartan three years ago.

 

NDMA, a carcinogenic substance detected in the Valsartan issue, is a harmful substance that does not have a standard.

 

Neither government nor pharmaceutical companies were able to recognize the dangers of detecting NDMA from raw materials for Valsartan.

 

The MFDS drew up a test method to detect NDMA in the raw materials of Valsartan, and prepared a new standard.

 

The fact that the cause of Azido is unknown also amplifies anxiety.

 

The MFDS looked at the manufacturing environment in which NDMA can be produced after the impurity Valsartan wave erupted.

 

NDMA detected in Valsartan-based drugs was created by chemical reactions during the manufacturing process.

 

In the process of manufacturing Valsartan, a major intermediary, "Biphenyltrazol", was manufactured, and NDMA was created in the process of synthesizing Biphenyltrazol and rapidly cooling it using nitric acid after tetrazol formation.

 

As with the initial discovery of NDMA, the risk of Azido is still unknown.

 

"People who take daily medicines containing Azido below the acceptable level for 70 years are not expected to increase their risk of cancer," Health Canada said.

 

Until recently, pharmaceutical companies have completed inspections of nitrosamine impurities such as NDMA and NDEA.

 

In November 2019, the MFDS ordered pharmaceutical companies to submit a report on the possibility of nitrosamine-based impurities in all raw materials and finished drugs, and the data submission was completed in a year and a half.

 

The MFDS must submit data on impurities in all medicines to allow lot release without testing for nitrosamines impurities.

 

However, if a large-scale suspension of sales due to the detection of excess impurities of a new type rather than nitrosamines, confusion over impurities is expected to spread throughout the industry.

 

An official from the MFDS said, "Recovery of drugs including Azido is currently underway in Canada alone.""In Canada, we expect to be able to collect related data through raw material drug clients as we have tested the impurities.

 

We are in the process of collecting information."