Italian regulators find problems at Kores' API plant in Roha

By Gareth Macdonald contact

- Last updated on GMT

Italian regulators say Kores Limited’s facility in Roha, India should be banned from supplying the API ambroxol hydrochloride to the EU and advised users to find an alternative source.

The Italian Medicines Agency​ (AIFA) made the recommendation in a post on EudraGMDP​ today, explaining that inspectors who visited the site in April found evidence of breaches of serious GMP non-compliance.

The agency said: “Major deficiencies were found in the following areas: electronic and paper analytical data integrity, QC activities, computerised systems security, analytical and process data manipulation, personnel, deviations and OOS management leading to a serious risk for public health​.”

It suggested national competent authority (NCA) and drug firms that source the API from Kores “assess the opportunity of requesting variation to the marketing authorisation in order to delete or substitute this manufacturer of the active substance​.”

AFIA also said that drugs containing the ingredient should be recalled and retested, unless there are no alternative suppliers and there is a risk of shortage.

The agency also warned the deficiencies observed at the facility could affect APIs.

The site also makes doxofylline, etofylline, acefylline, glimepiride, 3-methylxanthine, 2-amino-3,5-dibromobenzaldehyde, 8-chlorotheophylline,8-benzyl theophylline, bromhexine HCl, acebrophylline, theophylline, piperazine/acepifylline, theobromine, orphenadrine citrate/ base, pamabrom, ivabradine HCl, dorzolamide Hydrochloride.

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