Will impurities again in losartan trigger full recalls?

Industry“Impurities were detected in active substances of many generics”… lot releases being discontinued successively

Companies will submit self-inspection results to MFDS by end of the month…some have requested deadline extensions

Once again, impurity was detected in ‘losartan,’ an ingredient used in hypertension treatments.

 

The impurity in issue was detected during self-inspections conducted by the individual pharmaceutical companies under the direction of the Ministry of Food and Drug Safety, upon which some companies have been discontinuing the lot release of their products.

 

In particular, the companies are concerned that a large number of the drugs will be subject to recall, as they believe the raw materials imported from India and China that are used by most generic companies may be the cause of the problem.

 

The MFDS plans to take additional measures after receiving the companys’ test results by the end of this month.

 

According to the industry on the 16th, azido impurities were detected in their hypertension drugs containing losartan.

 

The azido impurity detected this time is known to be a different substance from the AZBT(5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole) that was detected in losartan last September.

 

At the time, excessive amounts of AZBT were found, and 22 lot numbers of 12 products in 11 companies were recalled.

 

The ministry's measures then were applied not only to losartan but also to other sartan drugs such as valsartan and irbesartan that were used to treat hypertension.

 

However, the impurity detected this time was only found in losartan.

 

Based on information overseas in late September, the MFDS ordered companies producing ingredients and finished products containing losartan to conduct individual tests for azido impurities, and submit their inspection results by the 30th of this month.

 

Pharmaceutical companies that detected excess impurities before submitting the results to the Ministry of Food and Drug Safety had stopped lot releases of their products as a precautionary measure.

 

A pharmaceutical company official said, “We have CMO agreements with 3 places, and all 3 places have told us that they will stop supplying their products due to impurity detection.

 

The word is that the ingredients from India and China that most generic companies use may be the cause of the problem.” Another company official said, “The impurity is presumed to be caused in the course of synthesizing raw materials.

 

Pharmaceutical companies that finished inspections reported their results to the Ministry of Food and Drug Safety last week and are preparing voluntary recalls." However, the MFDS has not made any statements yet.

 

The industry expects the ministry to make an official statement in early December after all the test results are submitted and the authorities prepare measures based on the results.

 

The industry has also requested an extension of the deadline for data submission, claiming that there was not enough time to derive results.

 

If the ministry accepts the deadline extension, the MFDS announcement is also expected to be delayed further.

 

Upon news of the impurities, the pharmaceutical sales market has been intent on finding alternatives.

 

The companies have been encouraging healthcare professionals to prescribe alternatives with a list of other sartan drugs that could replace losartan.

 

Currently, 376 drugs containing losartan are approved by the MFDS.

 

Depending on the magnitude of the recall, the impact on the pharmaceutical industry may also be significant.

 

Depending on the situation, there is also the possibility that pharmacies will also suffer from conducting the recalls.