Amega Biotech S.A.

What Amega Biotech S.A. does

Amega Biotech S.A. is an Argentine biosimilars manufacturer founded in 1998 in Buenos Aires and headquartered in Olivos. The company produces recombinant protein therapeutics using both mammalian (CHO) and bacterial (E. coli) cell culture platforms, spanning the full biopharmaceutical value chain from clone selection and cell line development through fermentation, purification, characterization, and finished dosage form manufacturing. It operates two cGMP-compliant production sites — a 1,500 m² Buenos Aires facility started in December 2005 with separate mammalian and bacterial production suites, and a second Santa Fe site built to international standards to expand capacity and access global markets — alongside two process development sites, a clinical/pre-clinical site, and a corporate office in Olivos.

The company's commercial portfolio covers biosimilars across six primary therapeutic areas: rheumatology (etanercept/TNF-alpha inhibitors), oncology (pegylated liposomal doxorubicin, filgrastim, pegfilgrastim), hematology (erythropoietin for chronic kidney disease and chemotherapy-induced anemia), fertility (folitropin alfa), pediatric endocrinology (somatropin growth hormone), and autoimmune/transplant (interferon beta-1a, mycophenolate mofetil). Both Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) are offered under proprietary brand names such as Enerceptan, Hemastim P, Peg-Neutropine, Neutropine, Somactive, Folitime, Megavex, Libende, Energavit, and Suprimun.

Amega became part of Megalabs in 2005, operating as the group's principal developer and producer of biotechnological products. Its go-to-market is event-driven and partnership-focused: it attends CPhI Worldwide and BIO International Convention, offers co-development, clinical trial collaboration, and technology transfer agreements to international pharmaceutical firms, and distributes through the Megalabs network across 18 Latin American countries and emerging markets in the Middle East, North Africa, Southeast Asia, and Eastern Europe. The company also wholly owns subsidiary Zelltek, located at the Parque Tecnológico del Litoral Centro, which was selected for COVID-19-related R&D under a national Argentine program.

Name

Amega Biotech S.A.

Legal name

Amega Biotech S.A.

Website

https://amegabiotech.com

Company type

Private

Founded year

1998

Operating status

Operating

Short description

Amega Biotech S.A. is an Argentine biosimilars manufacturer producing recombinant proteins — including etanercept, EPO, filgrastim, somatropin, and interferons — via integrated CHO and E. coli cell culture platforms. Part of the Megalabs pharmaceutical group, it distributes across Latin America and emerging markets.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals / Biosimilar Medicines

NAICS

Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)

akta.pro secondary industry

Process Development & Tech Transfer Services (upstream/downstream) (HLAAAKAF)

Keywords

• Biosimilar medicines
• Recombinant proteins
• Pharmaceutical manufacturing
• Biopharmaceutical development
• Biologics production

Headquarters

HQ city

Olivos

HQ country

Argentina

HQ region

Latin America

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Personnel, Technology or R&D, Infrastructure, Supply Chain, Marketing or Sales

Revenue model

1. Biosimilar Product Sales: Commercialization of proprietary biosimilar medicines including recombinant proteins for rheumatology, hematology, oncology, fertility, and autoimmune treatments. Both Active Pharmaceutical Ingredients (API) and Finished Dosage Forms (FDF) are commercialized.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Amega Biotech S.A. is an Argentine biopharmaceutical company that develops and manufactures biosimilar medicines and recombinant proteins. It operates a fully integrated value chain covering clone selection, cell line development, fermentation, purification, characterization, Active Pharmaceutical Ingredient (API) production, and Finished Dosage Form (FDF) manufacturing, using both mammalian (CHO) and bacterial (E. coli) cell culture platforms in cGMP-compliant facilities.

Product overview

AMEGA Biotech S.A. operates as a fully integrated biopharmaceutical company with an end-to-end value chain spanning from Active Pharmaceutical Ingredient (API) development and production to Finished Dosage Forms (FDF) manufacturing. The company produces biosimilar products covering therapeutic areas including oncology (Libende/Peg-Neutropine/Neutropine), hematology (Hemastim P/Erythropoietin, Energavit), rheumatology (Enerceptan/Etanercept), fertility (Folitime/Folitropin Alfa), pediatric endocrinology (Somactive/Somactive LF/Somatropin), autoimmune diseases (Megavex/Interferon Beta-1a), and transplant medicine (Suprimun/Mycophenolate Mofetil). The company's integrated model combines clone selection, protein purification, and formulation capabilities, with cGMP-compliant production facilities in Buenos Aires and Santa Fe, Argentina.

Differentiator

Problem solved

Functional benefit

Brands

• Enerceptan: Active Pharmaceutical Ingredient - Etanercept
• Folitime
• Peg-Neutropine
• Neutropine
• Somactive
• Somactive LF
• Megavex
• Hemastim P
• Energavit
• Libende
• Suprimun

Products and services

• Etanercept (Enerceptan) Active Pharmaceutical Ingredient used in treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and chronic plaque psoriasis.
• Folitropin Alfa (Folitime) Active Pharmaceutical Ingredient used for ovarian stimulation in women and spermatogenesis stimulation in men with hypogonadotropic hypogonadism.
• Pegfilgrastim (Peg-Neutropine) Active Pharmaceutical Ingredient - pegylated G-CSF used to decrease incidence of infection in patients receiving myelosuppressive chemotherapy.
• Filgrastim (Neutropine) Active Pharmaceutical Ingredient - recombinant human G-CSF used to reduce duration of neutropenia and incidence of febrile neutropenia in chemotherapy patients.
• Somatropin (Somactive) Active Pharmaceutical Ingredient - recombinant human growth hormone used for treatment of growth disorders in children and growth hormone deficiency in adults.
• Interferon Beta 1a (Megavex) Active Pharmaceutical Ingredient - recombinant human interferon beta used for treatment of multiple sclerosis and autoimmune conditions.
• Erythropoietin (Hemastim P) Active Pharmaceutical Ingredient - recombinant human erythropoietin used for treatment of anemia secondary to chronic renal failure, neoplastic diseases, HIV, and prematurity.
• Interferon Alpha 2b (Energavit) Active Pharmaceutical Ingredient - recombinant interferon alpha 2b used for treatment of various conditions including hepatitis and malignancies.
• Pegylated Liposomal Doxorubicin (Libende) Active Pharmaceutical Ingredient used for treatment of metastatic ovarian carcinoma, AIDS-related Kaposi's sarcoma, metastatic breast cancer, and multiple myeloma.
• Mycophenolate Mofetil (Suprimun) Active Pharmaceutical Ingredient - immunosuppressant used for prophylaxis of acute organ rejection in transplant patients.
• Enerceptan (Etanercept Finished Dosage Form) TNF-alpha inhibitor solution for subcutaneous injection (25mg/0.5ml, 50mg/1.0ml) indicated for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and psoriasis.
• Hemastim P (Erythropoietin Finished Dosage Form) Recombinant human erythropoietin solution for injection (2000UI/4000UI/10000UI) for SC or IV administration, indicated for anemia secondary to chronic renal failure, neoplastic diseases, HIV, and prematurity.
• Energavit (Elemental Iron Injection) Intravenous elemental iron formulation (sacarose) for treatment of severe iron deficiency when oral preparations cannot be used.
• Libende (Pegylated Liposomal Doxorubicin Injection) Pegylated liposomal doxorubicin dispersion for injection (20mg/10ml) indicated for treatment of metastatic ovarian carcinoma, AIDS-related Kaposi's sarcoma, metastatic breast carcinoma, and multiple myeloma.
• Peg-Neutropine (Pegfilgrastim Finished Dosage Form) Pegfilgrastim solution for subcutaneous injection (6mg/0.6ml) in pre-filled syringe for decreasing incidence of infections in patients with non-myeloid tumors receiving myelosuppressive chemotherapy.
• Neutropine (Filgrastim Finished Dosage Form) Filgrastim solution for injection (30 MUI) in pre-filled syringes for reduction of duration of neutropenia and incidence of febrile neutropenia in chemotherapy patients.
• Folitime (Folitropin Alfa Finished Dosage Form) Recombinant human FSH solution for injection in pre-filled cartridge (300 UI/0.5ml, 450 UI/0.75ml, 900 UI/1.5ml) for ovarian stimulation, superovulation for assisted reproduction, and spermatogenesis stimulation.
• Somactive LF (Somatropin Low-Formamide Injection) Somatropin solution for subcutaneous injection (5mg/1.5ml, 10mg/1.5ml) for treatment of growth disorders in children and growth hormone deficiency in adults.
• Somactive (Somatropin Lyophilized Powder) Somatropin lyophilized powder and pre-filled syringe for subcutaneous injection (4UI) for long-term treatment of growth disorders in children and growth hormone replacement in adults.
• Megavex (Interferon Beta-1a Finished Dosage Form) Recombinant human Interferon Beta-1a lyophilized powder for injection (30mcg) for intramuscular administration, indicated for treatment of relapsing multiple sclerosis.
• Suprimun (Mycophenolate Mofetil Capsules/Tablets) Mycophenolate mofetil (250mg hard capsules, 500mg coated tablets) for oral administration, indicated for prophylaxis of acute organ rejection in transplant patients.

Segments6 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• MegalabscoreStrategic or Co-development PartnerAMEGA Biotech became part of Megalabs in 2005 as the main developer and producer of biotechnological products. Megalabs is a leading pharmaceutical company in Latin America with over 7900 collaborators, presence in 18 countries, and a network of 17 production plants specializing in different pharmaceutical forms.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Market position

Strengths4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/gema-biotech

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Amega Biotech S.A.