Laboratorios Richmond in Argentina to expand ARV manufacture
Laboratorios Richmond, which manufactures the broadest range or antiretrovirals (ARVs) in the Argentinian domestic market, is investing $3 million in upgrading its facilities and exporting more of its ARVs abroad.
The company, which bought Organon’s plant in Argentina earlier this year as part of its expansion, manufactures 23 million units per year through local contract manufactures, but with the new facility, hopes to be able to manufacture 100 million units per year, and to double this If the business is good.
Elvira Zini, Richmond’s operation’s manager, told Scrip that the company was hoping to sell its ARVs to international organisations such as UNAIDS and the Clinton Foundation, but that it was struggling to perform WHO bioequivalence tests on some of its ARVs.
“We have proof of bioequivalence for all our ARVs in Argentina, but we need WHO prequalification, so we have to perform the tests again. We are hoping to get this for all our products but we are still discussing bioequivalence studies for nelfinavir, because these require more than 160 healthy volunteers and costs us $2,000 par volunteer, “Ms. Zini explained.
Richmond currently exports its ARVs to Bolivia. Paraguay. Uruguay, Colombia, Ecuador. Venezuela and Costa Rica, but with the expansion is hoping to export them in the near future to Spain and Portugal as well, Ms. Zini said: “We will send our first dossier to the EMEA in February, to start the registration process.”
…new patent law
One of the main reasons Richmond is expanding its ARV production abroad, Ms. Zini said, is because of the recent application of Argentina’s patent law, which allows companies to apply for product patents for all drugs manufactured since 1995, Before that, only the process could be protected – which was favourable to brand generics companies like Richmond. As a result, domestic companies must now look abroad to sell their products.
Richmond, which will have an estimated turnover of $26 million by the end of 2004, and has tripled its sales since 2002, also manufactures oncology products, anesthetics and general hospital drugs such as antibiotics, ARVs make up 50% of its sales.