Within weeks, Boehringer Ingelheim's U.S. generics operation, Roxane, will become part of Hikma, which picked it up in July in a $2.7 billion deal. But for now, it is the responsibility of the German company and so is the recall that the Ohio operation is undertaking.
According to the most recent FDA Enforcement Report, Roxane is recalling 16,270 bottles of tablets of the diuretic furosemide after it was discovered they were manufactured with the API that was intended for an oral-suspension version of the drug. The drugs were manufactured at the Roxane plant in Columbus.
The 875,000-square-foot manufacturing site in Columbus is one of the key features of the cash and stock deal, in which Hikma is giving Boehringer Ingelheim a 16.7% share of the Jordan-based company as part of the deal. It also gets a portfolio of products, R&D and marketing operations and 1,360 Roxane employees.
The plant manufactures 88 products, and while its particular strength is in immediate-release solids, it also produces liquid, dry-powder inhaler and nasal-spray dosage forms. It also makes high-potency products, technically complex formulations and controlled substances.
Last year, Hikma picked up Boehringer's Ben Venue Laboratories business in a $300 million deal that gave it a portfolio of sterile injectable products. It also got the massive sterile manufacturing site in Bedford, OH, that Boehringer had closed the year before after years of regulatory concerns. Rather than invest in getting the plant up to FDA expectations, Hikma moved the usable equipment to other sites.
- the recall notices are here and here