From The Editor | June 25, 2013

API Manufacturing: Alive And Well In The U.S.

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

Ed Miseta

Dr. Stephen Munk, president and CEO of API manufacturer Ash Stevens, had been taking Lipitor for years. But when his insurance company mandated a generic version of the drug, he was switched to one produced by Ranbaxy Laboratories, a manufacturer based in India. In November Munk learned that glass shards were found in the product. “I went to my pharmacy and told them I wasn’t happy about glass particles showing up in a drug I was taking,” he says. “They told me the FDA had not issued any guidance on it, so don’t worry about it. The entire incident was just further proof to me that U.S. API manufacturing was poised for significant growth.”


Munk believes the problems at Ranbaxy, which have also included admissions to the FDA of false testing data, recalls, and manufacturing problems, are a perfect example of why that is. In the last 12 years, Ash Stevens has spent more than $35 million expanding its operations in the U.S. Not bad for a small company, but Munk states they are not done. The company continues to buy more land around its facility in Riverview, Michigan and has plans to recruit and hire more staff. “We have been in business for 50 years, and we believe there hasn’t been a better time to be doing what we’re doing,” he says.