Argentina might have the first locally-manufactured medical cannabis product as soon as early 2021.
An official document shared by local pharmaceutical newspaper Pharmabiz shows that Manuel Limeres, head of Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT), authorized the company Laboratorio Alef Medical Argentina to register its Convupidiol product as a medicine.
The ANMAT authorization has a validity of five years.
However, Pharmabiz General Manager Cristina Kroll told Marijuana Business Daily “the company still needs to get the approval of the first (production) batch” in order for Convipidiol to become effectively available to patients.
She estimates that will not happen before the end of the first quarter of 2021.
This would be four years after Argentina’s approval of its medical cannabis law in March 2017, a sign of how legislative reform does not always translate into immediate – or even near-term – business opportunities.
Kroll said more companies are likely to obtain comparable authorizations for other products now that the first has been granted.
The medicine will be manufactured in Argentina and sold in 35-milliliter bottles, containing sesame oil, 10% CBD and vanilla flavor, according to a Convupidiol document seen by MJBizDaily.
It will be used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 and older, like FDA-approved Epidiolex.
According to the latest edition of MJBizDaily‘s Latin American report, only a tiny fraction of Argentinian demand for medical cannabis has been met with legal, commercially produced supply, typically through individual imports under a “compassionate use” special-access scheme.
Prohibitive costs associated with individual imports forces a large number of patients to rely on the illicit market.
Moreover, the Argentinian Ministry of Health has restricted the qualifying conditions to only refractory epilepsy, drastically limiting business opportunities in the South American country.