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OUR HISTORY

From development of the first active pharmaceutical ingredient to production of first finished dosage forms, AMEGA Biotech became a leading player for the production and commercialization of biotech-derived pharmaceuticals

» 2005 / 2006

ACQUISITION OF GEMA AND ZELLTEK

AMEGA Biotech starts operations in 2005 with the acquisition of both companies. In this way, an innovative biotechnology project is born for the development, production and commercialization of biotech-derived pharmaceuticals.

» 2009

APPROVAL FROM THE MINISTRY OF HEALTH (ANMAT) AS LABORATORY OF MEDICINAL SPECIALTIES

GEMABIOTECH becomes the first producer of Active Pharmaceutical Ingredients of biotech origin authorized by ANMAT and one of the first biotech production sites approved in Latin America.

» 2010

PRODUCTION OF INTERFERON BETA-1A FINISHED DOSAGE FORM

AMEGA Biotech started the path to development and commercialization of Finished Dosage Forms. Interferon Beta-1a is the first finished product developed for the international market.

» 2013

APPROVAL OF THE FIRST FINISHED DOSAGE FORMS ABROAD

First marketing authorizations were granted to Hemastim (Erythropoietin) in Mauritania and Gabon and to Peg Neutropine (Peg Filgrastim) in Ecuador, thus increasing AMEGA Biotech operations overseas.

» 2014

LAUNCH OF FINISHED DOSAGE FORMS IN ARGENTINA

Hemastim (Erythropoietin), Neutropine (Filgrastim) and Peg Neutropine (Peg-Filgrastim) were the first products launched in the local market, entirely developed and commercialized by GEMA Biotech.

2005

2009

2009

2009

2010

2011

2013

2014

2015

» 2009

INAUGURATION OF SANTA FE PRODUCTION SITE (ZELLTEK)

Production of biotech-derived Active Pharmaceutical Ingredients for human health was consolidated through inauguration of Zelltek manufacturing site in Parque Tecnológico Litoral Centro (Santa Fe, Argentina).

» 2009

GRANTING OF FSBIO AND FSNANO FUNDS

AMEGA Biotech strengthened its national positioning obtaining both subsidies awarded by the Ministry of Science, Technology and Productive Innovation. Through public-private consortiums, GEMA Biotech and Zelltek partner up with Universidad Nacional del Litoral and industry-related companies to contribute to the scientific-technological development of the country.

» 2011

FIRST FINISHED PRODUCT REGISTRATION CERTIFICATES OBTAINED IN ARGENTINA

First Finished Product registration certificates are obtained from the Local Ministry of Health (ANMAT).

» 2013

START OF CLINICAL TRIALS IN ARGENTINA

AMEGA Biotech consolidated its product registration platform for biopharmaceutical products with its own brand. This milestone also paved the way for product approvals in leading markets.

AMEGA BIOTECH, 10 YEARS

From development of the first active pharmaceutical ingredient to production of first finished dosage forms, AMEGA Biotech became a leading player for the production and commercialization of biotech-derived pharmaceuticals.

» 2005 / 2006

ACQUISITION OF GEMA AND ZELLTEK

AMEGA Biotech starts operations in 2005 with the acquisition of both companies. In this way, an innovative biotechnology project is born for the development, production and commercialization of biotech-derived pharmaceuticals.

» 2009

INAUGURATION OF SANTA FE PRODUCTION SITE (ZELLTEK)

Production of biotech-derived Active Pharmaceutical Ingredients for human health was consolidated through inauguration of Zelltek manufacturing site in Parque Tecnológico Litoral Centro (Santa Fe, Argentina).

» 2009

APPROVAL FROM THE MINISTRY OF HEALTH (ANMAT) AS LABORATORY OF MEDICINAL SPECIALTIES

GEMABIOTECH becomes the first producer of Active Pharmaceutical Ingredients of biotech origin authorized by ANMAT and one of the first biotech production sites approved in Latin America.

» 2009

GRANTING OF FSBIO AND FSNANO FUNDS

AMEGA Biotech strengthened its national positioning obtaining both subsidies awarded by the Ministry of Science, Technology and Productive Innovation. Through public-private consortiums, GEMA Biotech and Zelltek partner up with Universidad Nacional del Litoral and industry-related companies to contribute to the scientific-technological development of the country.

» 2010

PRODUCTION OF INTERFERON BETA-1A FINISHED DOSAGE FORM

AMEGA Biotech started the path to development and commercialization of Finished Dosage Forms. Interferon Beta-1a is the first finished product developed for the international market.

» 2011

FIRST FINISHED PRODUCT REGISTRATION CERTIFICATES OBTAINED IN ARGENTINA

First Finished Product registration certificates are obtained from the Local Ministry of Health (ANMAT).

» 2013

APPROVAL OF THE FIRST FINISHED DOSAGE FORMS ABROAD

First marketing authorizations were granted to Hemastim (Erythropoietin) in Mauritania and Gabon and to Peg Neutropine (Peg Filgrastim) in Ecuador, thus increasing AMEGA Biotech operations overseas.

» 2013

START OF CLINICAL TRIALS IN ARGENTINA

AMEGA Biotech consolidated its product registration platform for biopharmaceutical products with its own brand. This milestone also paved the way for product approvals in leading markets.

» 2014

LAUNCH OF FINISHED DOSAGE FORMS IN ARGENTINA

Hemastim (Erythropoietin), Neutropine (Filgrastim) and Peg Neutropine (Peg-Filgrastim) were the first products launched in the local market, entirely developed and commercialized by GEMA Biotech.

AMEGA BIOTECH, 10 YEARS

From development of the first active pharmaceutical ingredient to production of first finished dosage forms, AMEGA Biotech became a leading player for the production and commercialization of biotech-derived pharmaceuticals.