Chronology of our company
Approved Facilities - Lectrum in Argentina
The facilities of Eriochem are approved by the authorities of the Ministry of Health of Argentina (ANMAT)
The launch of Lectrum (Leuprolide Acetate depot 3.75 and 7.5 mg for a month) is performed in Argentina. Generic first in the world of this type of prolonged release products.
Lectrum in Latin America and Asia
Licenses are granted for the distribution of Lectrum in Latin America and Asia, including 38 countries in both regions.
Lectrum in Europe and Brazil / Vinorelbina and Oxaliplatino in Argentina
Licenses are granted for the distribution of Lectrum in Europe.
Brazil approves the facilities of Eriochem for Mercosur and, at the same time, grants the Free Sale Certificate for Lectrum.
The Argentine health authorities (ANMAT) grant the Free Sale Certificates of Vinorelbina and Oxaliplatino.
Lectrum in Brazil / Vinorel in India / New approvals
The launch of Lectrum in Brazil takes place.
India grants the Certificate of Free Sale of Vinorel (Vinorelbina tartrato).
United States approves the process patent for prolonged-release water-soluble peptide microcapsules.
The construction of the Pharmaceutical Plant II is started for the production of prolonged-release peptide microcapsules, in accordance with the European GMP regulations.
The European Community approves the method of production of Vinorelbina Ditartrate from plants of the Catharanthus genus and its industrial process in scale.
The Colombian health authorities (INVIMA) grant the GMP certificate for the manufacture of oncological APIs and oncological finished products.
The Drug Master File of Vinorelbina Tartrate is presented in the United States
The FDA (Federal Drug Administration of the United States) carries out an inspection for the approval of the Farmochemical Plant for the preparation of APIs.
EPO (European Patent Office) approves the patent process for the continuous production of micro-capsules for prolonged release of water-soluble products.
INFARMED (Ministry of Health of Portugal) performs a successful inspection at the Farmochemical Plant for the preparation of APIs.
The FDA approves the Drug Master File of Vinorelbine Tartrate.
Vinorel in Europe / New approvals
Portugal (EMEA) authorizes the marketing of Vinorel®.
A successful result of the Mutual Recognition Procedure (MRP) on the Drug Master File of Vinorelbine Tartrate is obtained in 15 European countries.
The Ministry of Health of South Africa (MCC) approves the Pharmaceutical Plant.
New facilities / Launches in Southeast Asia
Docetaxel and Oxaliplatino are launched in Indonesia.
ANMAT approves the Pharmaceutical Plant II.
The Ministry of Health of Belarus approves the Pharmaceutical Plant.
MERCOSUR re-certifies the GMP of the facilities of Eriochem
Oxalipaltino in Europe / Vinorel in South Africa
INVIMA of Colombia re-certifies the GMP of the facilities of Eriochem.
Vinorel was approved as the first oncology generic in South Africa.
A successful inspection of the BfArM (Health Authority of Germany), both in its API plant and finished pharmaceutical product.
The European Health Authority (EDQM) grants Eriochem the Certificate of Suitability (CEP 2007-130) for its product Oxaliplatino API.
Melfalano in Argentina
The first shipment of Oxaliplatin 50 mg and 100 mg was made to Europe, an oncological product manufactured in Argentina used for rectal colon cancer.
Eriolan (Melfalano) is launched in Argentina, used for bone marrow transplantation.
Docetaxel in Europe
The GMP (Good Manufacturing Practice) certificate is obtained, under the recommendations of the World Health Organization, issued by AFSSAPS France for the production of Docetaxel (20 mg, 80 mg and 200 mg) concentrate for injection.
GMP certification for manufacturing, packaging and testing for sterile solutions at the company's facilities is obtained from the Ministry of Health of Canada.
The decentralized procedure (DCP) for Gemcitabine 200mg and 1000mg in Europe ends, including the UK, Germany, Bulgaria, Romania, Slovakia and Cyprus.
A new subsidiary is created in Brazil, called Eriochem-Zenitec.
An opening ceremony was held for the start of the construction of its new pharmaceutical plant in the Science Zone in Uruguay.
New products in Canada - US FDA inspection
A new subsidiary is created in Nevada, United States, called Eriochem USA for the registration and commercialization of products as well as for the management of alliances with the commercial partners of the territory.
Health Canada approves the registration of Zoledronic acid (concentrate for injection) 4mg / 5ml.
The US FDA reports that the laboratory facilities were considered acceptable based on a report of an inspection performed for Vinorelbina Tartrate (API) and for two new pharmaceutical products (Docetaxel and Melfalano).
Pemetrexed and Melfalano in Europe / New subsidiary
The Spanish Agency of Medicines and Health Products issues the certificate of compliance with good manufacturing practices for the preparation, packaging and quality control of the Pemetrexed 100mg and 500mg product.
The MHRA of the United Kingdom authorizes the importation of Melfalan 50mg under an emergency import regime.
A strategic partner is formalized in Mexico, called ERIOMEX.
New approvals / Expansion of production lines
The Ministry of Health of Uruguay empowers Eriochem SZ S.A. (Uruguay) as a pharmaceutical operator in the Zona Franca Parque de las Ciencias in Canelones, Uruguay.
The FDA of the United States carries out the inspection for the approval of the Docetaxel 1 vial registry with successful results.
An expansion was made at the ``B`` Argentina Pharmaceutical Plant in order to install a new lyophilizer of greater capacity mainly destined to new projects for the US market.
Launching in the United States and Canada / Expansion of production lines
Launch of Docetaxel 1 vial in its presentation of 20mg, 80mg and 200mg in the US market. In this way, Eriochem becomes the first Argentine laboratory to launch an injectable oncological product in said territory.
Launch of Vinorel in Canada.
Construction begins on a new microsphere plant at the Entre Ríos plant in Argentina, which will expand Lectrum's production capacity.
The nanotransporter patent is presented in the United States, corresponding to the Nanoparticles project developed by Eriochem jointly with other companies and institutions.
Expansion of production lines
Construction begins on a new pre-filled syringe plant in Canelones, Uruguay.
The FDA of the United States makes a new inspection for the approval of the registration of Melfalano 50mg
The decentralized procedure (DCP) for the registration of Melfalano in Europe begins, including the UK, Germany, Austria, France, Spain, Hungary, Poland and Italy.