Impurity data on schizophrenia and asthma drugs submitted

Pharma companies await MFDS dispositions

Companies submit data on possibility of quetiapine impurities by May 27th

To submit data on distributed products by July… no products were recalled due to excess impurities

Companies also complete submitting test results on Montelukast … MFDS “Will make follow-up measures after review”

Pharmaceutical companies are submitting results of their impurity inspections on the schizophrenia treatment ‘Quetiapine’ and asthma and allergic rhinitis treatment ‘Montelukast’ one after another.

 

As of now, no product has been recalled due to excessive impurities, and the health authorities plan to take follow-up measures after reviewing the drug companies' impurity inspection data.

 

According to industry sources on the 7th, pharmaceutical companies submitted data on their schizophrenia treatment ‘Quetiapine’ to the Ministry of Food and Safety by May 27th.

 

The data contained the companies’ evaluation of the possibility N-Nitroso-Aryl Piperazine (NNAP) impurities, process safety review data, provisional management standards, and grounds for setting such standards.

 

This is a follow-up measure made after the MFDS requested the companies to submit impurity data on drugs that contain quetiapine in late April.

 

The MFDS ordered companies to submit test results on the companies’ representative batch numbers among finished quetiapine products that can be sold in the market by July 28th.

 

A representative batch number refers to three or more batches that are nearing expiry every year.

 

Products manufactured in 3 batches or less are required to submit test results of all batches.

 

This precautionary measure was made according to the safety information that NNAP impurity was detected in a single-agent quetiapine product.

 

The MFDS had ordered pharmaceutical companies to submit data including those evaluating the possibility of NNAP impurities in quetiapine products by May 27th.

 

NNAP is a new nitrosamine impurity that has been identified in the market.

 

.Since 2018, two types of nitrosamine impurities, - ‘N-nitrosodimethylamine (NDMA)’ and ‘N-nitrosodiethylamine (NDEA)’ were detected in valsartan, ranitidine, and nizatidine

 

.Quetiapine is a generic used to treat schizophrenia

 

.Its original is Alvogen Korea’s ‘Seroquel.’ Around 30 Korean companies are currently selling quetiapine generics, and the domestic market grosses ₩30 billion a year

 

.No quetiapine product in the market has been detected to have excess impurities in Korea yet, but it is impossible to rule out the possibility that some products with excess impurities may be found in the tests of finished quetiapine products

 

.Based on the submitted data, the MFDS plans to closely review the impurity risk of quetiapine products in Korea

 

.An MFDS official said, “We plan to make follow-up measures after the test results are submitted and a comprehensive review of all the results are made.” None of the montelukast products, on which the impurity issue had arisen earlier this year, have been recalled either

 

.The Ministry of Food and Drug Safety had previously ordered pharmaceutical companies to investigate their montelukast ingredient and finished products for impurities and submit the reports by April 25th

 

.This precautionary measure was issued after the ministry received safety information that N- nitrosodipropylamine (NDPA) was detected in the API montelukast

 

.Manufacturers and importers of montelukast were then required to submit test results on representative batch numbers that can be distributed in the market

 

.The MFDS asked the companies to conduct additional follow-up measures if necessary

 

.Manufacturers and importers of finished products are required to conduct evaluations on the possibility of impurities in the manufacturing process

 

.If necessary, the companies are also required to conduct tests and follow-up measures like the API companies

 

.The MFDS ordered companies that produce raw materials and finished products to immediately report NDPA impurities found during inspection even before the submission deadline

 

.Montelukast is used to treat allergic rhinitis and asthma

 

.The original drug is Organon Korea’s ‘Singulair.’ In Korea101 domestic pharmaceutical companies are selling generic versions with the same ingredient

 

.Its domestic market grosses around ₩100 billion a year

 

.The pharmaceutical companies had submitted impurity inspection results on montelukast products by April according to MFDS instructions, and no impurity issue has been identified in the products sold in Korea as of now

 

.In April, Organon Korea had announced that no impurities were detected in ‘montelukast sodium,’ the active ingredient of its allergic rhinitis and asthma treatment ‘Singulair.’ An MFDS official said, “We are currently reviewing impurity review data on montelukast, and will take the necessary safety measures according to the plan we have previously prepared.”