The ANMAT part of the market all medicines from a laboratory

The National Administration of Medicines, Food and Medical Technology (ANMAT) forbade this Thursday the elaboration, fractionation and commercialization in almost the entire country of all medicines manufactured by the KLADNO SRL laboratory for not presenting the corresponding authorization to carry out the interjurisdictional procedure.

The decision was communicated yesterday, February 16, through Provision 1363/2023 in which the agency prohibited the “use, distribution and commercialization throughout the national territory, except for the province of Buenos Airesof all the medicines produced by Laboratorio Kladno SRL until you obtain the corresponding authorization”.

The Directorate of Evaluation, Management and Monitoring of Health Products (DVPS), which depends on Anmat, reported on the sale of drugs manufactured by the firm in the area of ​​the City of Buenos Aires, noting that does not have an authorization record before the agency for interjurisdictional transit.

According to what the Ministry of Health of the province of Buenos Aires reported, the company is qualified as a manufacturer and fractionator of official drugs and medicines. However, its authorization registration before the ANMAT does not appear, so its preparation, fractionation and commercialization in other jurisdictions is prohibited.

The investigation initiated by the ANMAT discovered that there were medicines manufactured by KLADNO on the shelves of a pharmacy in the Federal Capital, in a majority that did not have the corresponding health authorization to work, as well as the offer of the drugs on the website of Free market.

Anmat: for the second time an ophthalmological drug is withdrawn from the market

After the Directorate of Technical Information Management checked and verified that the laboratory does not appear in the authorization registry before the National Administration, in the areas of medicines, cosmetic products, or medical products, to date, the agency prohibited “the use, distribution and commercialization of the medicines of Laboratorio Kladno SRL” throughout the country, except in the province of Buenos Aires until the corresponding authorization is obtained.

The ANMAT releases from the market a medicine indicated to prevent heart attacks and cardiovascular accidents

The National Administration for Drugs, Food and Medical Technology (ANMAT) decided to prohibit the commercialization of a medicine to prevent heart attacks and cerebrovascular accidents (CVAs).

The detachment of the market organism a batch of clopidogrel Rospaw after detecting “quality deviations”as detailed in an official statement.

“The population is informed that the firm ROSPAW SRL has initiated, a request from this National Administration, the withdrawal from the market of the product labeled as CLOPIDOGREL ROSPAW / CLOPIDOGREL (Hydrogen Sulfate) 75 MG, coated tablets, hospital presentation for 1000 units, Lot : 073210 – Expiration: 12/2023, Certificate No. 54057”, they detailed.

JP/fl