Fundacao Ataulpho de Paiva

What Fundacao Ataulpho de Paiva does

Fundação Ataulpho de Paiva (FAP) is a Brazilian non-profit foundation founded in 1900 (originally as Liga Brasileira Contra a Tuberculose) and headquartered in São Cristóvão, Rio de Janeiro. It is the sole domestic manufacturer of BCG vaccine in Brazil, producing a lyophilized intradermal BCG vaccine using the proprietary Mycobacterium bovis BCG Moreau Rio de Janeiro strain — a strain WHO-certified as a reference reagent (strain in 2005, vaccine in 2012) and the only such certified BCG in Brazil. FAP supplies 100% of Brazilian Ministry of Health demand under the National Immunization Program (PNI), with current annual output of 10–15 million doses at the São Cristóvão facility and a planned expansion to 35 million doses at a new 9,656 sqm Xerém/ Duque de Caxias plant under construction since 2016. The portfolio is anchored by two products: Vacina BCG (TB prophylaxis for newborns and children up to 4 years, distributed free through SUS public health posts) and Imuno BCG® (intravesical BCG immunotherapy for superficial bladder cancer, launched 2005, the only such product produced in Brazil, used in roughly half of national cases). FAP also runs social welfare operations including the Preventório Rainha Dona Amélia on Paquetá Island (since 1927), Ação em Campo community TB programs in Vila Rosário, and historical TB-HIV co-infection initiatives.

The business model rests on three revenue streams: (1) government vaccine sales to the Ministry of Health under multi-year PNI contracts (the dominant stream), (2) hardware sales of Imuno BCG and BCG to private vaccination clinics, hospitals, and oncology clinics through accredited distributors, and (3) technology licensing royalties from the Imuno BCG® transfer to Biofabri/Zendal (Spain). End customers span the Brazilian population for TB vaccination, oncology patients with superficial bladder cancer, and private healthcare providers; the foundation has historically operated without government subsidies, funding operations from product sales. In May 2023, Fiocruz/IBMP assumed institutional control and installed a new governance structure (Artur Couto as Diretor-Superintendente, Luiz Roberto Castello Branco as Diretor-Executivo) to recover production capacity, formalizing FAP's integration into the broader Fiocruz public health ecosystem. FAP holds strategic partnerships with WHO/PAHO, the Bill & Melinda Gates Foundation (InCo-TB project 2010–2014), the Global Fund (TB Brazil project 2007–2012), DCVMN, Fiocruz, and Biofabri/Zendal, and has published the complete genome and proteome of its proprietary BCG strain in collaboration with Fiocruz.

Name

Fundacao Ataulpho de Paiva

Legal name

Fundação Ataulpho de Paiva

Website

https://fundacaoataulphodepaiva.com.br

Company type

Private

Founded year

1900

Operating status

Operating

Headcount range

51–100 employees

Short description

Fundação Ataulpho de Paiva is a Brazilian non-profit foundation and the sole manufacturer of BCG vaccine in Brazil, producing the WHO-certified BCG Moreau Rio de Janeiro strain for tuberculosis prophylaxis and Imuno BCG® for superficial bladder cancer, exclusively supplying the national immunization program.

Ownership category

akta.pro rank

Product category

Biological Products (Vaccine Manufacturing)

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Vaccine Manufacturing & Fill-Finish (HLAIAEAJ)

akta.pro secondary industries

Vaccine Technology Platforms (mRNA, viral vector, protein subunit, inactivated/live-attenuated, VLP, DNA) (HLAAAEAD), Clinical Development & Regulatory for Vaccines (trials, pharmacovigilance, lot release) (HLAAAEAK), Vaccine Procurement, Tendering & Immunization Supply Programs (HLAIAEAN)

Keywords

• BCG vaccine production
• Tuberculosis immunization
• Bladder cancer immunotherapy
• Biological products manufacturing
• Vaccine research development

Headquarters

HQ city

Rio De Janeiro

HQ country

Brazil

HQ region

Latin America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Government Vaccine Sales: FAP sells the majority of its BCG vaccine production to the Brazilian Ministry of Health through the National Immunization Program (PNI). The vaccine is provided free to the Brazilian population at public health posts.
2. Imuno BCG Sales: Sales of Imuno BCG for treatment of superficial bladder cancer to hospitals and oncology clinics through distributors. FAP is the only producer in Brazil.
3. Technology Licensing: Technology transfer and licensing agreements for Imuno BCG to international partners, including Biofabri (Spain/Zendal group), representing a pioneering Brazilian biotech export.
4. Private Market Sales: Sales to private vaccination clinics through accredited distributors, for BCG vaccine and Imuno BCG products.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Fundação Ataulpho de Paiva manufactures the BCG Moreau Rio de Janeiro vaccine — a lyophilized intradermal biological product used to prevent tuberculosis, meningitis, and disseminated forms of the disease — as well as Imuno BCG®, an intravesical immunotherapy for superficial bladder cancer. Both products are derived from FAP's proprietary BCG Moreau RJ strain. As the exclusive domestic supplier, FAP fulfills 100% of the Brazilian Ministry of Health's demand through the National Immunization Program.

Product overview

Fundacao Ataulpho de Paiva is a Brazilian pharmaceutical foundation and the sole manufacturer of BCG-based immunobiological products in Brazil. Its portfolio consists of two core products: Vacina BCG (BCG Vaccine) for tuberculosis prophylaxis, distributed nationally through the Ministry of Health's National Immunization Program, and Imuno BCG for the treatment of superficial bladder cancer. Both products are derived from the proprietary BCG Moreau Rio de Janeiro strain. FAP also operates social assistance programs including the Preventorio Rainha Dona Amelia and the Acao em Campo project in Duque de Caxias. A new manufacturing facility in Xerem, Duque de Caxias, is being developed with Fiocruz/IBMP support to expand production capacity to 35 million doses annually.

Differentiator

Problem solved

Functional benefit

Products and services

• Vacina BCG (Bacilo de Calmette-Guérin) Lyophilized intradermal vaccine produced from FAP's proprietary BCG Moreau Rio de Janeiro strain (Mycobacterium bovis BCG with attenuated virulence), indicated for prophylaxis of tuberculosis, tuberculous meningitis, and disseminated forms of the disease. Administered as a single dose primarily to newborns in the first year of life (up to 4 years). Distributed free of charge through Brazil's National Immunization Program (PNI) via the Ministry of Health, which FAP supplies at 100% of national demand. WHO recognized the vaccine as a reference reagent in 2012.
• Imuno BCG® (Bacilo Calmette-Guérin intravesical) Intravesical immunotherapy product using the BCG Moreau Rio de Janeiro strain for treatment of superficial bladder cancer. FAP is the only producer of intravesical BCG in Brazil; the product is used in approximately 50% of all superficial bladder cancer cases nationally, demonstrating approximately 70% efficacy. Sold to hospitals and oncology clinics through accredited distributors; technology has been transferred to Biofabri (Zendal Group, Spain) for the European market.

Quantifiable outcome

• 75% reduction in tuberculosis risk when BCG administered before infection (Hart PD, Sutherland I. British Medical Journal, 1977)
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• Fiocruz/IBMP/Bio-ManguinhoscoreStrategic or Co-development Partner · 30 May 2023Fiocruz through IBMP became FAP's maintainer and assumed institutional control. New governance model with Artur Couto (Bio-Manguinhos) as Director-Superintendente and Luiz Roberto Castello Branco (FAP) as Executive Director. Validates FAP's ability to recover production capacity.
• Biofabri/Zendal (Spain)coreOEM/ Whitelabel/ Licensing Partner · 1 January 2018Technology transfer of Imuno BCG product completed 2018-2019. Biofabri (Zendal group) conducted ENCORE-01 clinical trial in Spain showing high efficacy of Moreau RJ strain. FAP completed first Brazilian biotech technology export to Europe, with European market registration expected.
• Pan American Health Organization (PAHO/WHO)coreStrategic or Co-development Partner · 1 January 2006FAP partnered with WHO to promote mass media campaign to help eliminate tuberculosis in Brazil. Objective was to raise public awareness about TB, emphasizing that it is a fatal but curable disease.
• Tulane University School of Public Health and Tropical MedicineminorStrategic or Co-development Partner · 1 January 2006Partnership through Tulane Educational Fund within 'Univ. Technical Assistance Projects Supporting Global AIDS Program'. Focused on strengthening National Tuberculosis Program in Rio de Janeiro state, particularly in laboratory capacity.
• French National Agency for Research on AIDS (ANRS)minorStrategic or Co-development Partner · 1 January 2005Partnership for project 'Health and Prison: HIV/AIDS and tuberculosis prevention and care in Brazilian prisons'. Addressed TB-HIV co-infection in correctional facilities.
• University of California Los Angeles (UCLA)minorStrategic or Co-development PartnerConducted first TB-HIV co-infection training in Brazil through formal agreement with UCLA.
• FIOTEC (Fundação para o Desenvolvimento Científico e Tecnológico em Saúde)coreStrategic or Co-development PartnerSuccessful partnership for execution of Global Fund project Objectives 1 and 2. FIOTEC was responsible for supervised treatment strategy and social mobilization activities while FAP managed laboratory quality and TB-HIV co-infection components.
• DCVMN (Developing Countries Vaccine Manufacturers Network)coreStrategic or Co-development PartnerFAP is a member of DCVMN, a voluntary organization of vaccine manufacturers from developing countries. FAP organized DCVMN workshop 'Critical Systems and Clinical Studies: Water, Air and Audits' in Rio de Janeiro, bringing together professionals from Latin America and global health institutions.
• FiocruzcoreStrategic or Co-development PartnerJoint research with Fiocruz/Bio-Manguinhos resulted in genome and proteome sequencing of BCG Moreau strain, making it the most studied BCG globally. FAP and Fiocruz jointly certified BCG Moreau RJ with WHO. Current partnership for FAP recovery through IBMP.

Scale indicators10 records

Recent moves8 records

Expansion highlights4 records

Market position

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/BCGFAP
• Facebookfacebook.com/BCGFAP
• LinkedInlinkedin.com/company/fundacao-ataulpho-de-paiva

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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

Frequently asked questions about Fundacao Ataulpho de Paiva