The product, Epifractan, is manufactured in Uruguay by Ramm Pharma and imported into Peru by Cann Farm, holder of the registry with the Peruvian General Directorate of Medicines, Supplies and Drugs (DIGEMID).
Magistral preparations first became available in Peru in December 2019, but this is the first time patients can buy a finished registered product in a Peruvian pharmacy.
“One of the advantages of registered products is precisely that they are supplied to pharmacies ready for dispensing to patients,” said Andres Vazquez, Cann Farm president.
According to Vazquez, “very few pharmacies in Peru currently have the required permits to be able to manipulate cannabis as a raw material to dispense (as) magistral preparations. In contrast, dispensing registered products like Epifractan is much simpler for pharmacies because they don’t need the magistral preparations specific authorizations.”
Vazquez said Epifractan is currently available in seven pharmacies in the chain Farmacia Universal, which are all in the capital, Lima.
Peruvian regulations allow companies to offer medical cannabis both as a magistral preparation or finished registered products.
And different categories are available within finished, registered products. Included are traditional pharmaceutical products – equivalent to an FDA approval in the United States – but also finished products for which no clinical trials were conducted to prove efficacy.
“While Sativex was registered like any other medicine with quality, safety and efficacy proven through clinical trials for a specific condition, Epifractan was registered as a ‘natural product’ based on its traditional use,” said Maritza Reátegui, partner and head of Rodrigo, Elías & Medrano Abogado’s life sciences and healthcare group.
“This means no health claims about medical treatments can be made for Epifractan, unlike the case of Sativex,” Reátegui said.
Epifractan is offered in 10 milliliter bottles with two concentrations available:
In the case of cannabis magistral preparations, only three pharmacies in Lima offer such products:
- Anden Naturals supplied a DIGEMID owned and run pharmacy with CBD. The pharmacy sells 10 milliliter bottles with almost 5% CBD for 48 soles.
- Khiron was the first company to offer magistral preparations through a private pharmacy, with Farmacia Universal starting sales in September. It offers 30 milliliter bottles with 3% CBD for 215 soles and 50 milliliter bottles with 10% CBD for 472 soles.
- Cann Farm in addition to importing the finished product Epifractan from Uruguay also imports CBD extracts from Clever Leaves in Colombia. These are used by QF Farmacia Magistral to dispense magistral preparations in one location of Lima. The product is offered in 10 milliliter bottles containing 5% CBD for 105 soles.
A prescription is always needed, even for products containing only CBD.