FDAnews Drug Daily Bulletin
Pharmaceuticals / GMPs / Inspections and Audits

Anuh Pharma Slapped for GMP Issues

April 6, 2016

In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate.

During a Feb. 12 inspection at the API maker’s Boisar, Maharashtra facility, inspectors allegedly uncovered 24 deficiencies, revealing problems with general finishing steps, manufacturing procedures and “the quality system of the company as a whole,” according to the agency.

The agency supposedly found one critical deficiency, which was Anuh’s failure to identify the original manufacturers of active ingredients to its customers. For example, a number of active substances appeared to be micronized from other sources, including one noncompliant source in China. Substances made at other sites reportedly were exported to Europe under the Anuh name.