The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) authorized the commercialization of one lakh 162 thousand 781 boxes of the drug for psychiatric care.
The shipments, containing amitriptyline, clozapine, alprazolam, zolpidem and amitriptyline/diazepam/perphenazine, belong to 148 batches produced by pharmaceutical company Psychopharma, which were approved after rigorous technical analysis.
With this third release, 9,792,124 boxes of psychiatric drugs may be available to patients in the country, according to a statement from Coffeeprice.
On May 12, it was announced that, in the first analysis, the manufacturer verified that 69 batches of clonazepam, lithium, methylphenidate and prolonged-release methylphenidate, i.e. one lakh 403 thousand 693 boxes, meet the tests prescribed by the Pharmacopoeia . United Mexican States (FEUM), and it is certain that they do not represent a health risk.
Subsequently, on May 14, this health authority authorized 7,225,650 boxes of clonazepam and methylphenidate belonging to 177 batches of drugs manufactured by the said manufacturer, which also demonstrated compliance with technical safety tests.
The authorization issued to the manufacturer allows commercialization only in the domestic market to comply with the principle of release useful for national supply.
The commercialization of the drugs shall be entirely the responsibility of the Company; Immediately upon release, these drugs shall be subject to an intensive pharmacovigilance plan in compliance with point 7.7.1. NOM-220-SSA 2016, which will guarantee detection of possible adverse events associated with its use.
Cofeprice reported that following the discovery of serious irregularities found at Psychopharma, the health authority actively designed a regulatory pathway that would drive progress in access to psychiatric care medicines.
Therefore, in a transparent manner, Cofepris supports the company to submit the documentation and necessary tests, focusing on high-priority keys for supply to the public and private sectors.