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Manufacturing

Set Alert for Manufacturing

Teligent Slammed By FDA Warning Letter

Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.

Manufacturing Compliance

Julphar Focuses On Quality As Carle Departs

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.

Manufacturing Middle East and Africa

Data Integrity Remains Challenging For API Manufacturers

Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.

Manufacturing Regulation

EU Regulators Prioritize Nitrosamine Evaluations Deadline

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.

Manufacturing Europe

Ophthalmics Are Next Frontier For Teligent

US niche generics player Teligent intends to use its expertise in topical and injectable drugs manufacturing to push into the North American ophthalmics sector.

 

Ophthalmic Business Strategies

Emcure Aims To Split Itself In Half

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.

Business Strategies United States
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