Hikma earns FDA closeout letter for its New Jersey plant

FDA inspectors paid a return visit to Hikma Pharmaceutical's New Jersey plant in February and found everything satisfactory. The FDA has now issued a closeout letter for the plant that was cited with a warning letter more than two years ago.

Jordan-based Hikma let the markets know on Wednesday that matters at its West-Ward plant in Eatontown, NJ, had been wrapped up. Production at the plant restarted last July, and the company has been reintroducing products to the market from the facility.

A February 2012 warning letter criticized the plant for manufacturing and testing issues that led to the release of lithium and digoxin tablets that failed size specifications. The FDA also said there were issues achieving the proper dissolution rate for the lithium carbonate tablets, a slow-release version often used with bipolar patients. At first the company continued production, but when FDA inspectors found new issues, it closed the facility in November 2012 to complete the work.

In its earnings report in March, Hikma said it had spent $39 million last year on remediation. But it also said that those costs were more than offset by sales of doxycycline, which had been in short supply for nearly two years because of manufacturing problems at the plants of other drugmakers. The drug is prescribed for treating Lyme disease, some sexually transmitted diseases, and some other conditions, including exposure to anthrax. Prices for the drug had skyrocketed during the shortage. Hikma reported last month that it expects its revenues to take a $100 million hit this year as competitors get their products back into the market

But Hikma still expects to grow revenue 5% this year, again propelled by making drugs that are in short supply because of issues with competitors' facilities. It also said that sales of products from the New Jersey plant will help. Hikma has picked up some transdermal and dermatology niche products that it intends to produce at the plant, along with reintroducing the product portfolio it already manufactures there.

- read the announcement
- here's the closeout letter
- here's the warning letter