WHO removes TB and malaria drug APIs made by Anuh Pharma from approved list
The World Health Organisation (WHO) announced the suspension yesterday, explaining that the move follows criticism of operations at the site by French regulator ANSM last month and the subsequent withdrawal of its GMP certificate.
The WHO said: “In the absence of current EU GMP certification, an acceptable standard of GMP can no longer be presumed at this [Boisar] facility.
“WHOAPI-158 and WHOAPI-234 will be removed from the WHO List of prequalified APIs until such time as WHO PQT can verify that an acceptable level of GMP is present at the manufacturing site.”
The APIs in question are pyrazinamide, which is used in tuberculosis drugs, and sulfadoxine, which is used in treatments for malaria.
The WHO told drug formulators to stop sourcing either ingredient from Anuh and to analyse any batches they have already purchased.
Anuh Pharma – which confirmed the suspension in a Bombay Stock Exchange (BSE) filing – has asked the WHO to re-inspect the facility.
ANSM criticism
Anuh facility processes APIs supplied by other manufacturers and supplies them to pharmaceutical producers.
ANSM inspectors who visited in February observed 24 deficiencies from good manufacturing practices (GMP) standards according to a report published on EudraGMP in March.
The major deviation was Anuh’s failure to pass details of its suppliers on to customers to which it sold processed active pharmaceutical ingredients (API).
The ANSM team also reported that azithromycin supplied to Europe labelled as being manufactured by Anuh was actually made by a non-compliant Chinese supplier called Hebei Dongfeng Pharmaceutical.
