With the Trump administration announcing plans to impose 25% tariffs on pharmaceuticals, it reignites a critical discussion ...

U.S. FDA classifies Aurobindo Pharma warehouse in New Jersey as Official Action Indicated, impacting compliance and ...

Subsequently, the US FDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated (OAI)'.

We assign Siegfried a Medium Morningstar Uncertainty Rating. Its business is relatively stable, with high switching costs and good visibility due to long-term customer contracts. However, small ...

Cadwalader’s Martin Weinstein says that weakening Foreign Corrupt Practices Act enforcement removes a shield for ethical US ...

In the backdrop of the US-India dialogue on tariffs, the Pharmaceuticals Exports Promotion Council (Pharmexcil), Indian ...

The manufacturer of the weight loss jab Wegovy has been reprimanded for allegedly failing to disclose or accurately report ...

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Voluntary action indicated (VAI) is suggested when violations are found, but the problems do not justify further regulatory ...

Pharmaceuticals account for 60% of all goods exported from Switzerland to the US. This means that significantly more medicines go to the US than are imported from there to Switzerland. It is well ...

This article is authored by Ranjit Barshikar, CEO, QbD International, CGMP Consulting, United Nations Adviser.