Editor’s (re)View: China and India dominate this week’s pharma manufacturing news
It was a short week due to the Christmas holiday, but there was no shortage of pharma manufacturing news from China and India — which is not surprising since more than half of the manufacturers supplying the U.S. drug market are operating in those two countries.
The week’s biggest news was WuXi AppTec’s announcement that it has agreed to sell — for an undisclosed amount — WuXi Advanced Therapies, its cell and gene therapy unit, to New York-headquartered private equity firm Altaris.
WuXi AppTec’s sale of WuXi Advanced Therapies — which operates five facilities in the U.S. and U.K. — was not a total surprise. In October, the Financial Times reported that WuXi AppTec and WuXi Biologics — both named in the BIOSECURE Act, which seeks to prevent federal funds from supporting certain China-based biotech “companies of concern” — were exploring sales of some of their respective U.S. and European operations. So far, there’s been no such announcement from WuXi Biologics.
While the passage of the BIOSECURE Act has stalled in Congress, the “ripple effect” of the proposed legislation “is already being felt by Chinese CDMOs” with contract manufacturers in the U.S., EU, and India seeing some “programs shifting to these geographies,” according to CPHI’s 2024 annual report.
Indian CDMOs are well-positioned and likely to benefit from the BIOSECURE Act. This week, India’s Akums Drugs & Pharmaceuticals announced it has signed a $200 million agreement with an undisclosed “leading global pharma company” to manufacture select oral liquid formulations for the European market.
By 2033, India could potentially account for 8% to 10% of work share outsourced to CDMOs globally, according to a recent report from consulting firm McKinsey & Company. However, some of these Indian companies will need to address a lack of quality control and adherence to good manufacturing techniques.
In Indian manufacturing news this week, generic drug company Viatris announced that the FDA has restricted the importation of 11 “actively distributed” products made at its facility in Indore, India. The regulator hit Viatris with a warning letter and an import alert, banning the 11 products from entry into the U.S. until the warning letter is lifted.
In other news, global CDMO Lonza announced that it is boosting capsule manufacturing capacity at the company’s facilities in Rewari, India and Suzhou, China. The surprising expansion comes on the heels of Lonza’s announcement earlier this month that it plans to exit its Capsules & Health Ingredients (CHI) business.
Lonza, in what appears to be mixed messaging on its strategy, said the new capsule manufacturing lines at the CHI facilities in India and China highlight the company’s “long-term strategic commitment to the business” and the Asia-Pacific region.
