The Argentine drugmaker Temis Lostaló has received the OK from Argentina’s regulator, ANMAT. The company is launching Nivelipol Resina, its own cholestyramine-based product, putting an end to the recurring lack of stock of Questran Light on the local market. The branded drug, which originally belonged to BMS, has been in constant shortage in Argentina since 2019.
Although there are often temporary shortages of medicines for various reasons, the case of Questran Light has been a longstanding issue in Argentina after the global manufacturer cut off deliveries to the local drugmaker Temis Lostaló, which had taken on the licence for the product in 2019. See article in Spanish.
As a result of the conflict, users of the product -most of them diagnosed with chronic diarrhoea and other intestinal diseases- were left desperately searching for a solution. Pharmabiz itself received more than 50 inquiries regarding the status of Questran from concerned patients.
However, and after a period of uncertainty, the Argentine firm, which is owned by the Macchiavello family, devised a way around the matter. The company is launching Nivelipol Resina, its own locally made version of the product, which has begun to be distributed through drugs wholesalers this week.
Temis Lostaló’s own brand based on cholestyramine is made at its plant located in the Buenos Aires neighbourhood of Barracas. The. company signed a distribution agreement for Questran in Argentina in November 2019 with Germany’s Cheplapharm, which bought the branded product from US drugmaker BMS in August 2018. See Press Release.
There had already been shortages of Questran in pharmaceutical retail while it was still under BMS. When Pharmabiz contacted the global manufacturer after the sale, the multi’s regional head of sales in Latam, Werner Görlich responded that the company had registered shortages not only in Argentina but also in other countries.
The recurring shortages are attributed to production problems related to the supply of the active ingredient cholestyramine. In mid-2019, the Italian Medicines Agency (AIFA) ordered the temporary blocking of exports of all Questran presentations to ensure local availability. See Press Release.
Several European countries import medicines from Italy at lower prices, thus the measure directly targeted the main markets where Cheplapharm owns the product. In addition to Italy, these are Belgium, Germany, France, the United Kingdom, the Netherlands, Argentina and Brazil.
In the latter, the product is under the US drugmaker Moksha8, the official licence holder in Brazil. In Uruguay, there are two drugs based on cholestyramine: Celsius’s Resincol and Gramon Bagó’s Cinecolex. See article in Spanish.
