Hikma Pharma says US FDA lifts warning on Eatontown facility

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Home Gotcha Hikma Pharma says US FDA lifts warning on Eatontown facility 02-04-2014 09:47 AM Ammon News - (Reuters) - Hikma Pharmaceuticals Plc said on Wednesday that the U.S. Food and Drug Administration had lifted the warning on its Eatontown facility in New Jersey where it makes oral products for the U.S. market. The Jordanian company, which makes and markets branded and non-branded generics and injectibles, said it was gradually reintroducing products to the U.S. market from the facility. The company had suspended manufacturing at the plant in 2012 after receiving an FDA warning letter. Hikma said corrective actions have been taken in response to the letter. Hikma's Eatontown facility underwent extensive remediation work in 2013 and was reinspected by the U.S. FDA in February 2014.

Home Gotcha

Hikma Pharma says US FDA lifts warning on Eatontown facility

02-04-2014 09:47 AM

Ammon News - (Reuters) - Hikma Pharmaceuticals Plc said on Wednesday that the U.S. Food and Drug Administration had lifted the warning on its Eatontown facility in New Jersey where it makes oral products for the U.S. market.

The Jordanian company, which makes and markets branded and non-branded generics and injectibles, said it was gradually reintroducing products to the U.S. market from the facility.

The company had suspended manufacturing at the plant in 2012 after receiving an FDA warning letter. Hikma said corrective actions have been taken in response to the letter.

Hikma's Eatontown facility underwent extensive remediation work in 2013 and was reinspected by the U.S. FDA in February 2014.

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