Regulations

News from Laurus, ZCL Chemicals and Johnson Matthey: API briefs

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A round-up of developments in the API sector with news from Laurus, ZCL Chemicals and Johnson Matthey.

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US FDA approves Amgen and Allergan's Avastin biosimilar

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Synthon says EPO appeal board has revoked Copaxone API patent

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Biocon says Malaysia insulin plant passed HPRA inspection

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No fraud, no conspiracy, no error: France and Merck say reformulated Euthyrox is safe

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German inspectors find problems at Dr Reddy's' Duvvada plant

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When is a commercially available chemical not "commercially available"? ICH issues new Q11 Q&A

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Ageing facilities & drug shortages: industry concern drives guidance for manufacturers

Celltrion's facilities in Incheon, South Korea were inspected by the US FDA in may and June

Celltrion confident in quality of biosimilar supply despite US FDA 483

Cadila facility in Moraiya (source Cadila)

Cadila says Moraiya drug plant has passed US FDA inspection

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