Aurobindo, Glenmark US Recalls: Asia News Roundup

(the article has been updated to make it concise and cohesive)

Two major Indian drug makers, Aurobindo and Glenmark, have issued recalls for drugs sold in the U.S. market due to Good Manufacturing Practice (GMP) deviations. The recalls affect over 200,000 bottles/packs of various medications, including Cinacalcet, a drug used to manage parathyroid disorders. The issue with Cinacalcet involves the presence of an impurity, N-nitroso Cinacalcet, which exceeds the FDA-recommended interim limit. This follows a broader trend of increasing scrutiny over drug manufacturing practices and safety standards.

In a separate matter, Takeda Pharmaceutical held its R&D Open Day in Tokyo on December 13, marking the first such event in five years. CEO Chris Weber emphasized the company’s focus on developing blockbuster drugs in the areas of sleep disorders and dermatology. Despite these innovations, Takeda is also facing challenges, with plans for large-scale layoffs and the closure of research facilities. The loss of key patents and the pressures of maintaining profitability were also mentioned as contributing factors to the restructuring.

On a concerning note for Japan's pharmaceutical sector, the country has seen the highest number of pharmacy bankruptcies in a decade in 2024. According to data from Teikoku Datebank, over 30 pharmacies have gone out of business, with total debt reaching 14.3 billion yen. Many of these pharmacies, particularly prescription drug pharmacies, have been struggling due to aging ownership and difficulties in operations. The closures highlight a significant challenge for the Japanese pharmacy industry, which may face further pressure in the coming years.