This time it’s acyclovir… impurity issue rises again

MFDS orders NDMA testing on the antiviral acyclovir according to recall information overseas

Test results on over 3 batch numbers to be submitted by September

The drug impurity risk issue has spread to the antiviral acyclovir.

 

According to the impurity issue that arose abroad, the health authorities have started making safety measures on pharmaceutical companies.

 

According to industry sources on the 23rd, the Ministry of Food and Drug Safety has recently ordered pharmaceutical companies to conduct a review for N-nitrosodimethylamine (NDMA) impurities on finished drugs that contain acyclovir.

 

The MFDS has ordered the companies to submit test results conducted on the companies’ representative batch numbers of the finished acyclovir products available on market.

 

Products that are manufactured in below 3 batch numbers are required to submit test results of all batches This safety measure was made according to the safety information that finished tablet products containing acyclovir were recalled abroad due to excess NDMA impurities.

 

The MFDS ordered companies to immediately report their test results after completion even before the impurity data submission deadline.

 

Acyclovir is an antiviral used for the ‘treatment and prevention of initial and recurrent genital herpes, Herpes Simplex Virus Encephalitis, and Mucocutaneous Herpes Simplex Virus Infection’ as well as for the ‘treatment of herpes zoster (Shingles).’ Its annual outpatient prescriptions amount to 15 billion won a year.

 

This is the first time an impurity issue arose in the area, and around 50 companies sell acyclovir tablets in Korea.

 

With acyclovir, the total number of ingredients with new impurity risks increased to 3.

 

The MFDS had previously requested pharmaceutical companies to investigate their montelukast imported and manufactured APIs and finished products for N-nitrosodipropylamin (NDPA) impurities and submit its results in January.

 

In April, the MFDS had ordered pharmaceutical companies to submit data including the impurity test results and data on the possibility of N-Nitroso-Aryl Piperazine (NNAP) impurities in quetiapine products.