Ardena Pamplona

Ardena Pamplona

Focusing on small-molecule oral solid drugs, our Pamplona site specializes in highly potent compounds and differentiating technologies

Walking the smartest path to your clinical milestones

Focusing on small-molecule oral solid drugs, our Pamplona site specializes in highly potent compounds and differentiating technologies including spray drying, from development to clinical manufacturing for early and late phases, as well as commercial manufacturing of niche drugs.

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Drug Product Formulation Development

Drug Product Formulation Development

We guide our customers into making smarter formulation choices. This reduces the risk of clinical failure and ensures your product reaches the clinic rapidly via the most efficient route.

Solving a problem and saving time, overcoming your development challenges is our specialty. We work with you to understand your product needs and develop the best possible formulation.

Drug Product Manufacturing

Drug Product Manufacturing

From our facilities to our people, we are engineered to be top performers. We deliver consistent non-GMP and GMP drug product manufacturing services to the highest standards and to your timescales.

We can handle a variety of dosage forms including highly potent compounds and controlled substances with a specialism in small-scale batches

Solid Dispersions

Solid Dispersions

Amorphous solid dispersions increase solubility by eliminating the impact of crystal lattice energy on the dissolution process.

The physical stabilization of the amorphous state of the drug substance is accomplished via dispersion in a polymer matrix. We identify polymers with sufficient solid-state miscibility with the drug substance to prevent recrystallization and ensure consistent performance over time via a combined approach of precipitation assays and solvent evaporation trials, both conducted at a milligram scale.

Formulation concepts with adequate performance and physical stability are subsequently scaled-up and GMP-produced via spray drying or bead coating.

We provide a comprehensive solution to your solubility, stability and bioavailability problems by combining experience and capabilities in formulation, analytical and process development and technologies including spray drying. We also have suites capable of handling highly potent active substances.

High Potency

High Potency

Our laboratories feature 100% air renewal and the necessary personal protective equipment and other measures in place to guarantee the safety of our operators and the secure handling of your potent products.

We deliver GMP manufacturing of highly potent drugs in a dedicated facility with clean rooms that meet EU-GMP class C standards (ISO 7, US FED STD 209E class 10000 equivalent).

At the start of each development or manufacturing project, we carry out a thorough risk analysis of your active substance, ranking its operational exposure level (OEL) or band. We take into consideration the characteristics of our facilities and equipment, as well as the necessary personal protective equipment and the properties of the active substance to determine that we can safely handle your materials.

In most circumstances, we can work with substances in categories 1 to 4 (up to OEL of 0.1 µg/m3), which comprise the overwhelming majority of HPAPIs and products.

Your molecule, your journey, our mission.

Get in touch to see how we can craft your path to the clinic with dedicated capabilities.

Get in touch

Canal Interno de Información (Canal de Denuncias)

En cumplimiento de la Ley 2/2023, de 20 de febrero, reguladora de la protección de las personas que informen sobre infracciones normativas y de lucha contra la corrupción, ARDENA PAMPLONA ha implantado un Canal Interno de Información.

Este canal permite comunicar, de forma confidencial y segura, posibles infracciones del Derecho de la Unión Europea, así como acciones u omisiones que puedan constituir infracciones penales o administrativas graves o muy graves.

Principios del canal:

  • Confidencialidad: Se garantiza la protección de la identidad del informante y de cualquier tercero mencionado.
  • Prohibición de represalias: No se permitirá ningún tipo de represalia contra quienes comuniquen información de buena fe.
  • Anonimato: Se admite la presentación de comunicaciones anónimas.
  • Independencia: El sistema es gestionado de forma autónoma e imparcial.

Ámbito de aplicación:
Podrán utilizar este canal: empleados, directivos, colaboradores, proveedores y cualquier persona que haya obtenido información en un contexto laboral o profesional con la organización.

Protección de datos:
El tratamiento de los datos personales se realizará conforme al Reglamento (UE) 2016/679 (RGPD) y la normativa vigente en materia de protección de datos.

Para acceder al canal, puede hacerlo a través del siguiente enlace: https://whistleblowersoftware.com/secure/ardena

Ardena Pamplona SL
Pol Mocholí, C. Noáin, 1
31110 Noáin, Navarra
Tel: +34 948 21 40 23

 

Esta empresa ha recibido dos subvenciones del Gobierno de Navarra al amparo de la convocatoria de 2020 de ayudas para mejora de la competitividad (expedientes 0011-1463-2020-000045 y 0011-1463-2020-000115) 

Esta empresa ha recibido una ayuda cofinanciada al 50% por el Fondo Europeo de Desarrollo Regional a través del Programa Operativo FEDER 2014-2020 de Navarra

Esta empresa ha recibido una subvención del Gobierno de Navarra al amparo de la convocatoria de 2021 de ayudas para mejora de la competitividad (expediente 0011-1463-2021-000052)

Esta empresa ha recibido una subvención del Gobierno de Navarra al amparo de la convocatoria de 2022 de ayudas para mejora de la competitividad (expediente 0011-1463-2022-000080)