Towa International receives ANVISA certification to export medicines from its Spanish plant to Brazil

Advancing quality and regulatory compliance 

• The certification granted by the Brazilian Health Regulatory Agency (ANVISA), Brazil’s regulatory authority for medicines, confirms that Towa International’s plant in Spain meets the demanding international quality standards required to manufacture and export to the Brazilian market.
• This recognition reinforces the company’s position as an international industrial hub, with an annual production capacity exceeding 6 billion doses.

Barcelona, May 26, 2026 – Towa International, the international hub of Towa Pharmaceutical and a company specialised in the research, development, manufacturing and distribution of generic medicines, has received certification from the Brazilian Health Regulatory Agency (ANVISA), Brazil’s regulatory authority for medicines.

This certification confirms that Towa International’s manufacturing plant in Martorelles (Barcelona) complies with the strict Good Manufacturing Practices (GMP) required by ANVISA, validating the robustness of its quality systems, manufacturing processes and controls to ensure medicines that meet the highest standards of quality, safety and efficacy.

Mónica Coronas, Chief Quality Officer at Towa International, has stated: “ANVISA certification validates our plant’s excellence model and the high standards of our quality systems, which are based on continuous improvement, process traceability and a strong regulatory compliance culture. This recognition reflects the ongoing work of our teams and our commitment to ensuring medicines are manufactured under the highest quality standards for our patients and customers.”

The ANVISA certification, associated with a CMO product, forms part of the company’s international growth plan, whose main objective is to expand access to high-quality medicines for as many patients as possible worldwide, thereby contributing to more equitable access to essential treatments. Globally, Towa International markets its products directly in Europe and the United States through Towa Pharmaceutical (Spain, Italy and Portugal) and Breckenridge Pharmaceutical, and indirectly in more than 40 countries through its Towa2B business unit, further strengthening its international footprint.

David Peix, CEO of Towa International, has added: “This new milestone reinforces our commitment to internationalisation and enables us to continue progressing towards our goal of reaching a greater number of patients worldwide. Brazil represents a strategic market, and this certification demonstrates the strength of our Spanish plant as a driver of international growth.”

Following this approval, Towa International will be able to export directly from Spain to Brazil, reinforcing the role of the Martorelles plant as an international manufacturing centre with the capacity to operate in highly regulated markets.

The plant also holds certifications from the US FDA, European authorities (AEMPS / Gencat) and Japan’s PMDA, among others, and has an annual production capacity exceeding 6 billion doses, consolidating its position as one of the main industrial platforms of the Japan-based Towa Group.