Hypertension drug recall by USFDA shot in the arm for some drug majors

The recent recall of a common hypertension drug in the US due to contamination with a carcinogen has opened up short-term opportunities for a handful of Indian players. 

The issue with sartan (hypertension drug) began around July, when the US Food and Drug Administration (USFDA) notified health care professionals of a voluntary recall of several drug products containing the active ingredient valsartan. Valsartan is used to treat high blood pressure and heart failure. 

The recall was due to an impurity (N-Nitrosodimethylamine or NDMA) which was found in the recalled products that include valsartan and its combinations. 

According to the USFDA’s list of products under recall, four companies - Teva, Prinston, Torrent, and Hetero - have recalled products containing the valsartan active ingredient. The USFDA also placed primary Chinese supplier Zhejiang Huahai Pharmaceutical on import alert. The European Medicines Agency also withdrew the authorisation for the Chinese valsartan product maker. 

This created a supply shortage in the market. The companies, whose drugs were recalled, have to change the source of their active pharmaceutical ingredient (API), take fresh approvals for the product containing the new API, and launch it again in the US market. 

According to reports, the prices of some of the variants of the product went up in the US market around August-September. 

Firms like Alembic and Jubilant saw an opportunity here. Around August-September, Jubilant Pharma, Mylan NV, and Alembic Pharmaceuticals were selling the drug in the US market. 

Alembic, in fact, saw its international revenues increase 124 per cent year-on-year in the second quarter, riding on this one-time supply opportunity. “If valsartan sales were taken out, then the US revenue growth would be over 20 per cent or so,” said a senior company official.

Others like Lupin, too, see an opportunity in this. Lupin is a backward integrated company. In a September audit of its Tarapur facility, Lupin’s valsartan API was found to be safe by the USFDA. 

A company spokesperson said, “With the successful completion of USFDA’s recent audit at Lupin’s Tarapur plant, sartans, namely valsartan, losartan, and irbesartan, manufactured by Lupin are declared safe for human use. This has helped Lupin maintain supplies of finished products to the US market. Lupin additionally supplies finished products of sartans to other markets like Europe, Japan, and Australia, using in-house manufactured sartans.” 

The company has started production of additional API to meet further requirements of sartans. He added, “We have started production of additional API to meet further requirements of sartans for the India market and continue to be ready to meet any increased need for our sartan group of products, globally.”