Hikma gets FDA warning letter for plant in Portugal

Hikma Pharmaceuticals got a closeout notice in March for a warning letter that had been hanging over its West-Ward plant in New Jersey. But at nearly the same time, inspectors were looking over a Hikma facility in Portugal, and the Jordan-based company says the FDA has now issued a warning letter for its sterile injectables plant there.

The company said it got the letter Oct. 23 for an inspection done in March of this year. It said inspectors expressed concerns about how the facility had handled investigations at the plant, as well as about environmental monitoring at the facility. "Hikma takes this matter very seriously and will work with the FDA to fully resolve all outstanding issues," the company said in its statement.

The company also said it didn't expect the warning letter will impact the manufacturing or distribution of the products manufactured in its Portugal facility or its financial guidance.

Reuters said the drugmaker manufactures powder, liquid and lyophilised injectable drugs at the Portugal plant, which opened in 1997. Last year, the drugmaker earned $536 million, or nearly 40% of its revenues from injectables, with sales in the U.S. accounting for 68% of that. Hikma has been growing its injectables business and in August reported that growth in that area was up 41% in the first half of the year.

But Hikma has seen its financial pictures impacted in the past because of quality problems. The revenues in its generic drug division last year were dragged down by remediation costs at its West-Ward plant in Eatontown, NJ. It closed the plant in 2012 for a while after the FDA issued a warning letter, citing it for manufacturing and testing issues that led to the release of lithium and digoxin tablets that failed size specifications. The company last year began ramping up production at the facility and the FDA in March of this year issued the closeout letter for the facility.

Hikma last year spent about $45 million on remediation but was able to more the cover those costs with growth in the generics unit with sales of the antibiotic doxycycline. The FDA had placed doxycycline, a drug used for treating things like Lyme disease, on its shortage list after problems with other manufacturers created supply problems. Demand drove up the price and because Hikma had supplies, it was able to reap big rewards.

Hikma has been building its capacity in sterile injectables, as well as its portfolio. Earlier this year it agreed to pay up to $300 million to buy the generic injectables drugs that Germany's Boehringer Ingelheim sold under its Bedford Laboratories brand. It also picked up the Bedford, OH, sterile injectables plant that Boehringer closed at the end of the year. Instead of reopening it, Hikma said it would remove newer equipment in the plant and use it in its other facilities. It has 27 manufacturing facilities in 11 countries.

- here's Hikma's announcement
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