Labiana wins new EU approvals and Latin America deal

Labiana added new European marketing authorizations, secured a supply agreement for Precyst in seven Latin American countries, and launched two veterinary medicines in Spain. The moves extend the Spanish group’s push to grow its human and animal health pipeline across international markets.

Why it matters: - Labiana is turning regulatory approvals into commercial expansion across Europe and Latin America. - The new authorizations and launches support the Spanish pharmaceutical group’s strategy to grow both its human health and veterinary businesses. - The latest progress comes after Labiana posted its strongest financial performance in 2025, with revenue of €75.2 million and profit of €2.6 million.

What happened: - Labiana obtained two marketing authorizations in Sweden and two more in Portugal for medicines containing empagliflozin, an oral antidiabetic agent. - Labiana also secured two marketing authorizations in the Netherlands for medicines containing octreotide, used to treat certain endocrine and digestive disorders. - The company won the first five marketing authorizations for Precyst, a women’s health dietary supplement formulated with D-mannose and cranberry extract, through an agreement with one of Latin America’s leading pharmaceutical companies. - Under that agreement, Labiana will supply Precyst in seven Latin American countries. - Labiana launched two veterinary medicines in Spain: an injectable robenacoxib product for pain and inflammation in dogs and cats, and an acepromazine-based sedative and preanesthetic for dogs.

The details: - The empagliflozin and octreotide approvals advance Labiana’s human health pipeline in strategic European Union markets. - The Precyst agreement expands Labiana’s out-licensing and international supply footprint in Latin America. - The new veterinary launches add to Labiana’s commercial portfolio and show the company can move products from regulatory development to market execution. - Labiana said its products are marketed in more than 114 countries. - The company said its products are available in more than 150 markets and that its presence is supported by two GMP-compliant manufacturing plants in Spain, subsidiaries in Turkey, Ecuador and Mexico, a stake in Serbia, and licensing agreements with international distributors. - Labiana has two business lines: contract manufacturing and proprietary products. - Labiana debuted on BME Growth in June 2022 as the first veterinary company listed on the market in Spain.

Between the lines: - The mix of EU registrations, Latin American licensing and Spain launches suggests Labiana is using multiple channels to scale rather than relying on one market or one product line. - The company’s emphasis on regulatory capability matters because approvals can unlock revenue without requiring entirely new manufacturing infrastructure. - The latest moves also reinforce Labiana’s push to balance stable contract manufacturing with higher-growth proprietary products. - Sandra Villagrasa, Labiana CEO, said the new registrations and launches reflect the company’s international growth strategy and its ability to develop, manufacture and bring products to scale internationally.

What's next: - Labiana is likely to continue pursuing additional registrations, launches and out-licensing agreements in Europe and Latin America. - The company’s broader international network gives it room to expand commercialization beyond the latest approvals and launches. - Further execution on the pipeline will determine how quickly the new authorizations translate into sales.

The bottom line: - Labiana is widening its global footprint by pairing regulatory wins with product launches and cross-border supply deals.