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Pyrazinamide and Sulfadoxine, two APIs of the Indian pharma manufacturer Anuh Pharma Ltd has been removed from the WHO list of pre-qualified APIs by the World Health Organization.
The step has been taken as a result of an inspection of the French Medicines Agency, ANSM wherein a statement of GMP non-compliance with 24 deficiencies was issued to Anuh Pharma and same was informed to WHO. The GMP certificate was withdrawn by the French authorities and hence WHO said that the APIs will remain off the list until the GMP compliance status is received again by the company.
The GMP status can be regained either through an internal WHO review of the EU inspection report once the EU GMP compliance status has been reinstated, or a WHO led inspection. Hence, Anuh Pharma has requested a WHO GMP inspection so that the arrangements can be made accordingly.