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Vega Life Sciences Warning Letter Shows Difficulty Of Applying Drug GMPs To API Solvent Recyclers

 
• By Bowman Cox

Recycling offers economic and environmental benefits, but risks introducing potentially carcinogenic impurities. Company barred from US market.

Warning hazard sign and signage man falling
a point of no return • Source: Shutterstock

A recent US Food and Drug Administration warning letter provides more insight into how difficult it will be for active pharmaceutical ingredient manufacturers to retain the economic and environmental benefits of solvent recycling without risking the introduction of potentially carcinogenic impurities such as nitrosamines into drug products.

The warning letter the agency sent on 17 June to Vega Life Sciences Private Ltd., an API solvent recycler...

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