French regulators have identified another Indian API maker they say lacks just about every kind of good manufacturing practice needed to produce acceptable drugs, sanitation, data integrity and sample control. As a result, they have recommended the European Medicines Agency recall all of its products and not allow them to be used in any new drugs.
French regulators have recommended that drugs containing APIs made at Nandu Chemicals Industries’ site in Hubli, India be recalled after uncovering “serious” problems during an inspection in August.
Nandu Chemicals Industries Fails EDQM Inspection
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