Labiana secures six EU approvals and seven-country Latin American supply agreement

Spanish pharmaceutical group Labiana Health has expanded its regulatory and commercial pipeline through six new marketing authorisations in the European Union, an agreement covering seven Latin American countries and two veterinary product launches in Spain.

The developments span Labiana’s human and animal health businesses and form part of a strategy based on combining contract manufacturing with the development and international licensing of proprietary products.

In Europe, the company received four marketing authorisations for medicines containing empagliflozin, an oral antidiabetic agent. Two approvals were obtained in Sweden and another two in Portugal.

Labiana also secured two authorisations in the Netherlands for medicines containing octreotide, a compound used in the treatment of certain endocrine and digestive disorders.

The company did not disclose the individual product presentations covered by the approvals, their expected launch dates or whether the medicines will be marketed directly or through local partners.

Obtaining a marketing authorisation establishes the regulatory basis for placing a medicine on the market, but it does not necessarily imply immediate commercial availability. Launches may still depend on manufacturing schedules, distribution agreements and, where applicable, national pricing and reimbursement procedures.

The approvals strengthen Labiana’s human health portfolio in three EU markets and could also support future licensing or supply agreements with pharmaceutical companies seeking products that already have regulatory clearance.

The second component of the expansion is focused on Latin America. Labiana said it had obtained the first five regulatory authorisations for Precyst, a women’s health dietary supplement formulated with D-mannose and cranberry extract.

The approvals were secured in cooperation with an unnamed pharmaceutical company described by Labiana as one of the region’s leading industry groups.

Under the associated agreement, Labiana will supply Precyst in seven Latin American countries. The company did not identify those markets, disclose the duration or value of the contract, or provide sales forecasts.

It also did not specify whether authorisations remain pending in the other countries covered by the agreement. Commercial implementation may therefore proceed at different speeds depending on local regulatory requirements.

The transaction gives Labiana a route to extend the product’s geographical reach through an established regional partner. This model can reduce the cost and time required to build proprietary distribution networks in each country, while allowing the Spanish company to concentrate on product development, manufacturing and supply.

Latin America already forms part of Labiana’s corporate structure. The group has subsidiaries in Ecuador and Mexico, alongside operations in Spain and Turkey and a holding in Serbia.

The European approvals and Latin American agreement are accompanied by the introduction of two injectable veterinary medicines in Spain.

One contains robenacoxib and is intended for the treatment of pain and inflammation in dogs and cats. The other is based on acepromazine and is used as a sedative and pre-anaesthetic for dogs.

Labiana did not disclose the commercial names of the two products or their projected contribution to revenue. Their launch nevertheless expands the group’s veterinary portfolio and moves two products from regulatory development into commercial distribution.

The company operates two complementary business lines. Its contract development and manufacturing activities provide pharmaceutical services to third parties, while its proprietary portfolio covers products developed, manufactured or marketed under its own commercial strategy.

This combination allows Labiana to use the infrastructure and technical capabilities developed for contract manufacturing to support its own pipeline. The group operates two manufacturing plants in Spain that comply with good manufacturing practice standards.

Its proprietary products are registered in more than 114 countries, supported by local subsidiaries and agreements with international distributors. Labiana has traded on BME Growth since June 2022 and was the first veterinary pharmaceutical company to join the Spanish market for small and medium-sized growth businesses.

The latest regulatory milestones follow a year of revenue and earnings growth. Labiana reported €75.2 million in revenue for 2025, an increase of 13.5% from the previous year.

Net profit reached €2.6 million, approximately twelve times the level recorded in 2024. The company attributed the improvement to growth across its human and animal health divisions, an expanded portfolio and a larger contribution from international markets.

Managing director Sandra Villagrasa said the approvals and launches reflected the group’s regulatory, industrial and product-development capabilities, as well as its ability to take medicines from development to international commercialisation.

The financial effect of the latest announcements cannot yet be determined because Labiana has not released contract values, expected sales volumes or market-launch calendars.

Their strategic relevance lies instead in the combination of two expansion routes: securing national authorisations in regulated European markets and using licensing and supply partnerships to enter multiple Latin American countries.

Labiana’s next challenge will be converting those regulatory and contractual milestones into recurring sales. That will depend on the timing of product launches, execution by local partners and the ability to expand initial registrations into broader commercial portfolios.

The structure of the Latin American agreement also provides a possible template for further international growth. Rather than establishing a complete commercial organisation in every market, Labiana can use regional pharmaceutical partners to distribute products while retaining its role in development and manufacturing.

For the Spanish group, the latest approvals and supply agreement broaden its addressable markets without changing the foundations of its business model. The commercial outcome, however, will only become visible as authorised products reach pharmacies, veterinary channels and healthcare providers.