IDIFARMA is a leading Contract Research and Development Organization for the pharmaceutical and biotechnology industries.

Based in Spain, and with an increasingly international reach, IDIFARMA provides a full range of services that encompasses: drug formulation, development and validation of analytical methods, quality control and batch release in the EU, Pilot-Scale GMPcompliant manufacturing, ICH stability studies, clinical trial logistics management and regulatory support. Our state-of-the-art facility features a purpose-built high containment plant for the manufacturing of GMP-compliant pilot and clinical batches in oral solid dosage forms, for both conventional and high potency drugs. Our pilot plant is equipped with the latest technology and is also used for the optimization of manufacturing processes. IDIFARMA's expertise, capabilities and proven track record make us the perfect partner for the development of your projects.

GMP Pilot Plant

Scan to visit our Pilot Plant Cofinanciado por:

Clinical Batches Manufacturing High Potency Capabilities Manufacturing Process Optimization

GMP Clinical and Pilot batch manufacturing

IDIFARMAs cGMP-compliant pilot plant is equipped for the manufacturing of solid oral dosage forms of both conventional and high potency drugs (cytostatic, cytotoxic, hormonal, hormone inhibitors). Our authorization also includes the manufacturing of placebo formulas necessary for many clinical trials. Highlights: Fully GMP certified facilities. Tablet manufacturing capacity: Clinical and Pilot-Scale Batches (complying with EMA Scientific Guidelines). Capsule manufacturing capacity: Clinical Batches. Highest quality equipment from top vendors (Httlin, Fette, Manesty, IMA) that ensures a smooth tech transfer to industrial manufacturers. Equipment with advanced control systems technologies (CFR Part 11 compliant). Ability to manufacture with organic solvents. High containment (if necessary): 100% air renewal, personal protective equipment, paperless manufacturing guides, remote data acquisition system. Maximum flexibility to meet clinical trials requirements. Future investment plan for two new Pilot Plants: sterile products and conventional products.
Oystar Httlin Pilotmix 75T single-pot high shear mixer Single pot, top drive technology Capacity up to 75 litres Organic solvents capability Advanced control system technology (CFR Part 11 compliant) Cleaning-In-Place system Up to 200 litres bins

Fette 1200iC rotary tablet press EU-B and EU-D punch types Fully instrumented Maximum flexibility: from single-tablet pressing with manual filling to actual manufacturing process simulation. IMA Clinipack blister machine Up to 90 blisters/min Maximum flexibility for clinical trials Ability to thermoform and coldform the blisters using all the currently available packaging materials.

Oystar Manesty XL Lab 01 tablet coater Interchangeable drums Batches from 0,5 to 24 litres. Water based and organic solvents Pellet coating capability Advanced control system technology (CFR Part 11 compliant)

Manufacturing process optimization

The plant can also be used for optimization of production processes, pursuing goals such as reducing costs, eliminating waste, improving lead times and taking full advantage of production equipment features.