Salvat becomes the first Spanish pharmaceutical company to receive FDA approval for sterile drug manufacturing using BFS technology

  • The pharmaceutical company Salvat has received FDA approval to manufacture Otovel, an ear drop solution for the treatment of acute otitis media, at its Pharmaloop facility in Alcalá de Henares for distribution in the U.S. market.
  • In addition to Otovel, Salvat is expected to produce three more products from its otolaryngology and ophthalmology lines for the U.S. market in the coming months.
  • The launch of Pharmaloop and the FDA authorization have led to the creation of more than 150 highly skilled jobs and an investment of over €80 million.
  • This new milestone further consolidates Salvat’s position as a leader in ophthalmology and otolaryngology, with four lines of single-dose products and one of sterile multi-dose products.

Salvat, an international pharmaceutical company and manufacturer of products such as Cristalmina, Relive, Otovel, Tebarat, and Cetraxal, is significantly expanding its presence in the global market. The Pharmaloop plant, located in Alcalá de Henares (Madrid), has become the first facility in Spain to receive FDA authorization for the manufacturing of sterile products using BFS technology for the U.S. market. The approval from the U.S. Food and Drug Administration (FDA) covers the production of Otovel, an ear drop solution for the treatment of acute otitis media.

Pharmaloop is also working towards obtaining FDA approval to manufacture three additional solutions: Cetraxal, for the treatment of acute external otitis; Clotrimazole, an antifungal solution for the treatment of otomycosis; and Clobetasol, a corticosteroid for post-surgical ophthalmic treatment. These solutions will be produced in Spain and are expected to be shipped to the U.S. in 2025.

With this manufacturing authorization, Salvat Laboratories not only completes its business chain but also opens the door to manufacturing for third-party companies interested in distributing BFS technology-based solutions in the U.S. market.

A State-of-the-Art Facility

Designed from the outset to meet FDA standards, the construction of the plant in 2019 involved an investment of €65 million. With the addition of personnel, energy activation, and machinery setup, the total investment has reached €80 million.

In 2023, Pharmaloop generated more than 100 jobs, and today, it has created over 150. Given the high-tech nature of the plant, these positions are filled by highly qualified professionals, including pharmacists, technicians, mechanics, and engineers, all trained to operate the sophisticated technology at Pharmaloop.

Focus on Ophthalmology and Otolaryngology

This latest milestone consolidates Salvat Laboratories as a leading player in the fields of ophthalmology and otolaryngology, with four lines of single-dose sterile products and one line of multi-dose products.

The company already offers several BFS technology-based solutions in European markets, targeting conditions such as glaucoma, conjunctivitis, post-surgical ophthalmic care, external otitis, acute otitis media, and allergic rhinitis, among others.

Alberto Bueno, CEO of Salvat Laboratories, highlighted the importance of the FDA approval: “We believe this is a key milestone in our international strategy. Having FDA clearance to manufacture certain sterile medications at Pharmaloop for the U.S. market gives third parties the confidence to rely on our facility. This not only boosts our business potential but also enhances our ability to provide the public with sophisticated solutions for their health needs,” he explained.