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US FDA rejects Sun epilepsy drug due to ongoing problems at Halol plant

The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.

US ban for Changzhou Jintan Qianyao raises questions about customers says expert

The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”

Granules India confirms $35m US plant expansion will create jobs

Granules India says adding manufacturing capacity at its facility in Virginia, US will create 102 jobs.

Eye drops to replace painful injections in AMD patients

The University of Birmingham has developed a cell-penetrating peptide it claims could be used to make eye drop versions of age-related macular degeneration drugs currently delivered by injection.

EMA proposal concerns: “Public health trumps commercial confidentiality”

Proposed amendments to the EMA's access to documents policy have been criticised by medicines watchdogs, including not-for-profit Health Action International and Prescrire.

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