South Korean pharmaceutical companies face annual loss of around 33 billion won ($29.2 million) as the result of a ban on sales of anti-hypertensive generic drugs after key ingredient valsartan sourced from China was found to be contaminated with a carcinogen, according to data.
Among the affected drugs, Kolmar Korea’s Hiforge topped the list last year with sales of 3.34 billion won, followed by Daehan New Pharm’s NP-Forge (2.29 billion won) and Samik Pharm’s Cadenza (2.28 billion won), according to market research firm IQVIA Korea on Wednesday.
Korean health authorities recently followed the suit of the European Medicines Agency (EMA) in the order of recall on high blood pressure drugs containing valsartan sourced from China. The ingredient was found to have impurity of N-Nitrosodimethylamine (NDMA), a class 2 carcinogen designated by the International Agency for Research on Cancer (IARC), a World Health Organization subsidiary. The measure affects 219 products from 82 pharmaceutical companies in Korea.
The Korean market of the drugs containing valsartan is estimated at 290 billon won. Most of these valsartan drugs are available as a combination with other ingredients.
Novartis Korea’s Diovan and Exforge, the two originator valsartan products, posted 92 billion won in sales last year and represented 32 percent of the market. The two brands are now immune to the sales ban.
A total of 2,690 products are approved as hypertensive medication in Korea and they use valsartan, losartan, eprosartan or others as key API.
By Shin Chan-ok and Minu Kim
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