UPDATED: Hikma remediation to cost it generic sales

Jordan-based Hikma Pharmaceuticals ($HIK), which has indicated that it has big plans to grow, says it received an FDA warning letter for its plant in Eatontown, NJ. The company warns that the remediation at the oral dosage manufacturing plant will mean lost sales. That will mean lower earnings for the year. The company today reported it that expects a decline of about 13% in generic drug sales for the year, Reuters reports. It is now expecting sales in the range of $130 million to $135 million. The company just last month said it has $300 million earmarked for M&A and organic growth this year with key targets being the Middle East and North Africa. The Feb. 3. warning letter says Hikma's West-Ward Pharmaceuticals unit needs to fix manufacturing and testing issues that have permitted the release of lithium and digoxin tablets that fail size specifications. The FDA says the plant allowed the release of batches of lithium carbonate extended release tablets, USP 450 mg, that are outside specifications for thickness and hardness. The letter notes West-Ward agreed to suspend production of the lithium tablets while it assesses the process changes. Story | More

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