Institute of Good Manufacturing Practices India
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USFDA warns Unimark  over violating GMP norms

The US Food and Drug Administration (USFDA) has issued a warning letter to Unimark Remedies for violating current good manufacturing practice norms at its plant near Ahmedabad in Gujarat. Unimark, a vertically integrated healthcare company, aims in developing affordable generic medicines in various therapeutic segments such as respiratory, cardiovascular, anti-infective, central nervous system for global markets.

"An inspector in March had found significant deviations from current good manufacturing practice for the manufacture of active pharmaceutical ingredients at the plant,” said the USFDA in a warning letter. The violations included failure of the company to document production and analytical testing activities as they are performed


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