Alchem International Steps Up to Resolve Supply Gap In Tropane Alkaloid APIs

With several European principal players exiting the market, Alchem International has committed to continue the manufacture of tropane alkaloid active pharmaceutical ingredients (APIs) crucial for the manufacture of numerable drugs and therapies.

This range of APIs includes Atropine, Atropine Sulfate, Tropine, Nortropine, Homotropine Methylbromide, Homotropine Hydrobromide, Digoxin, and Cimetropium Bromide, which are characterized as anticholinergics or stimulants used to manufacture inhalers, auto-injectors, and treatments for allergic reaction or poisoning.

Raman Mehta, CEO and President of Alchem, explains that because this particular range of APIs is considered a niche, it’s hard to manage in large scale production facilities, but it can be handled in facilities that can support smaller scale manufacturing.

This move aims to prevent drug shortages that can leave the industry vulnerable to counterfeit drug distribution, which is not only bad for business, but endangers the life of patients.

In late 2013, the National Association of Boards of Pharmacy (NABP) released a white paper stressing the importance of closing regulatory gaps and the potential dangers implicit in drug shortages.

In recent years, drug shortages in the United States have nearly tripled and, according to the Robert Wood Johnson Foundation (RWJF), many have turned their blame to the market. According to the brief, these problems are not as prevalent in Europe where drug makers are compensated differently.

Following the Food and Drug Administration Safety and Innovation Act (FDASIA) signed into Law by President Obama in 2012, the FDA has stepped up their commitment to staying on top of drug shortages, reporting these to the public, and working closely with manufacturers to fill in the gaps.

According to the New York Times, shortages have persisted despite FDA efforts to stem the problem. Though the FDA has succeeded in preventing more shortages, the total number of shortages has continued to grow.

Ralph Neas, CEO of the Generic Pharmaceutical Association, explained this persistence, saying that the only way to prevent shortages was through the collaboration between regulators and manufacturers and through manufacturer cooperation.