Natalia Vitela/ Agencia Reforma
mondays, 15 may 2023 | 08:54
CDMX.- The Federal Commission for the Protection against Sanitary Risks (Cofepris) authorized the commercialization of seven million 225 thousand 650 boxes of clonazepam and methylphenidate belonging to 177 batches produced by Psicofarma, after the suspension of operations of the company’s plants that caused the collapse of these medications.
According to addiction, these drugs approved a rigorous technical analysis.
In fever, Cofepris concluded that Psicofarma did not meet the criteria of sufficient quality and adhered to national and international standards.
Among the irregularities, the use of laboratory test batches as a finished product to be sold was detected, as well as the manufacture of medicines without regard to good practices.
However, after the anomalies found and before the complaints on the part of patients with mental illnesses who suffered the breakdown of psychotropic drugs, Cofepris provided support to the company so that it delivered the required documentation and tests.
“On May 12 it was announced that, in a first analysis, the manufacturer confirmed that 69 batches of psychiatric drugs, and said, a million 403 thousand 693 of boxes, complied with the tests determined by the pharmacopea of the United Mexican States, and if have the certainty that they do not represent a risk to health”.
The reason for following the principle of “useful release for the national supply”, both authorizations delivered to the manufacturer determine that said drugs can be released only for the national market, what currently represents, need Cofepris, more than eight million and half of cajas de Psychiatric care medications may be available for patients in the country.
