Chongquing Succeway made APIs in undeclared plant and faked records says ANSM

By Gareth Macdonald

- Last updated on GMT


Related tags Pharmaceutical drug Pharmacology

French regulators says Chongquing Succeway Pharmaceutical Co Ltd should recall APIs made at its plant in Chongquing after inspectors found evidence of record manipulation and an undeclared manufacturing area.

France’s Agence Nationale de Sécurité du Médicament (ANSM) who visited the facility last month identified 22 problems according to a report​ filed on the EudraGMDP website on July 24.

The agency said it had found evidence Chongquing Succeway had backdated and falsified batch manufacturing records, records of supplier audits as well as chromatography results.

The French inspectors also said they had discovered an “undeclared workshop without any traceability of the activities undertaken​” and evidence of the “undeclared storage of unidentified product without any traceability.​”

Chongquing Succeway’s production of rilmenidine dihydrogen phosphate, an active pharmaceutical ingredient (API) used in several hypertension medications, prompted the inspection.

ANSM urged ​Chongquing Succeway to recall drug ingredients made at the plant and said the site should be not named in any new marketing authorisations.

It also said: “​The existence of MAs or MA variations referencing an active substance manufactured by this site has to be verified. In these circumstances, the removal of the site from the MA should be considered using QRM principles.”

Chongquing Succeway did not respond to a request for comment.

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