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Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.
As its CEO Jerome Carle steps down following a 67% slump in sales to date this year, UAE-based Julphar is hopeful of putting manufacturing problems behind it under a new management team.
Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.
EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.
US niche generics player Teligent intends to use its expertise in topical and injectable drugs manufacturing to push into the North American ophthalmics sector.
By the middle of next year, Emcure intends to have demerged its operations in highly developed markets from its activities in India and other emerging markets. The Indian group is seeking private-equity support to grow inorganically in North America and Europe.
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