FAES FARMA | DERIO facility

FAES FARMA | DERIO facility

Developer and manufacturer of human medicinal products.

About the plant

Founded in 1933, FAES FARMA develops, manufactures and commercializes pharmaceutical products and APIs, with a wide-ranging international projection.

Today, FAES FARMA, the company that began more than 90 years ago in a small Basque factory, is now present in Europe, Latin America and Africa.

Indeed, our origins have defined us, but it is even more important to know how far we want to go: to take care of people s health today in order to have a healthier society tomorrow.

FAES FARMA CDMO

NICHE DRUG DOSAGE FORMS: UNIFILL (VERTICAL THERMOFORM FILL AND SEAL UNI-DOSE), SOFT GELATIN CAPSULES, BILAYER TABS & SOLID & LIQUID STICKS (UNI-DOSE).

ORAL SOLIDS (TABS, CAPS), LIQUIDS (SYRUPS, DROPS), TOPICALS, SUPPOSITORIES...

HIGH PHARMA QUALITY & CAPACITY

• Modern, high-capacity manufacturing plants.
• Development and manufacture of products marketed in more than 100 countries.
• GMPs: US FDA, ANVISA, Japan PMDA, European Agencies, etc.

COLLABORATION MODELS

Development

• Formulation design, optimization, and stability testing.
• Tailoring drug formulations for maximum efficacy in the development stage.
• GMP manufacturing for clinical trials.
• Small to medium batch sizes with a focus on flexibility and quality control.

Manufacturing

• Scalability assessment, process optimization, and pilot-scale production.
• Large-scale GMP manufacturing, up-scaling.
• Move to industrial scale with optimized processes and technology transfer support.
• Navigating the regulatory landscape with strategic support.
• Customized packaging solutions, distribution logistics, and compliance with global standards.
• Ensuring product integrity from development to global distribution.

Bulk & FDF

• Niche forms: Sticks, Bilayer tabs, Unifill, Soft Capsules.
• Traditional Forms: Tablets, ODT, Capsules, Suppositories, Ointments, Syrups, Drops...

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• French Service-Public (CIR)
• ECOVADIS
• World Health Organization (GMP / HACCP)
• NMPA (China GMP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• ANMAT (Argentina nueva GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• ISP (Chile BPM)
• INVIMA
• MSPAS
• COFEPRIS
• DIGEMID
• MHRA (UK GMP)

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Activity

• Oral liquids and semisolids, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Bulk, Sachets, Stick packs, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Tablets, Hard capsules, SoftGel capsules, Granules / Pellets, Powders, Bottles, Dropper bottles, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
• DEA: N/A
• BSL:
• Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system
• Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, Clean room rental, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Release testing of raw materials, Release testing of product, Analytical methods transfer, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support

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