The ANSM has just rendered a decision that affects Cargill France, a company producing alginic acid, a compound found in certain drugs.
The National Medicines Safety Agency (ANSM) pinpoints the company Cargill France, which produces raw materials for drug manufacturers. From now on, it will no longer be authorized to produce and market the alginic acid designed at its site in Lannilis, in Finistère.
This substance, created from brown algae, is used in the encapsulation of certain drugs, in the making of dressings, or to thicken certain cosmetic products.
Lack of quality controls
The ANSM inspected the site during the summer and noted several dysfunctions, which led to its decision. First, until December 2014, the site had operated without the agreement of the agency. However, any company that manufactures products for the purpose of manufacturing drugs cannot do without them.
In addition, the ANSM controllers noted problems with the monitoring and traceability of the equipment cleaning systems, a deterioration of the equipment involved in the manufacture of alginic acid. They also denounce the inadequacy of checks on the quality and conformity of the batches used in the development of their products.
No risk
The ANSM specifies that this suspension was decided as a precaution. Analyzes of the alginic acid produced on the Finistère site are in progress. However, no risk has been identified for patients who use drugs based on Cargill France products.
The problems identified would also affect the appearance and taste of drugs more than their properties. Nine people complained last year of a bad taste or fishy odor when they consumed drugs containing alginic acid produced by Cargill France. The ANSM tests should help reassure them.
.
