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Teva Catches A Break On Copaxone 40mg, But For How Long?

 
• By Jessica Merrill

An FDA warning letter cites deficiencies at the Pfizer-owned manufacturing facility poised to produce a Momenta/Sandoz generic competitor. It’s unclear how long Pfizer might take to resolve the violations, which include particulates in finished products.

Teva Pharmaceutical Industries Ltd. has gotten some breathing room with news that the launch of a generic rival to the important 40mg version of its blockbuster multiple sclerosis drug Copaxone (glatiramer) has been delayed due to a manufacturing issue.

An FDA warning letter, made publicly available Feb. 28, cites several manufacturing violations at the Pfizer Inc.-owned facility in...

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AstraZeneca Pledges Big Investment In US Manufacturing Amid Tariff Threats

 
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