Content Group | Pomezia Plant

Content Group | Pomezia Plant

Tubilux Pharma: registered office; manufacturing facility

About the plant

Content Group is an all-Italian pharmaceutical CDMO composed of COC Farmaceutici and Tubilux Pharma. The Group develops and manufactures liquid, gel, cream and lyophilized pharmaceuticals, medical devices and cosmetics for human and veterinary use. With decades of experience in ophthalmic and respiratory sectors, Content Group is among Europe’s leading players, serving partners worldwide with full CDMO services, innovation and quality as core values.

Tubilux Pharma | Pomezia (RM)

The Pomezia site is the registered office and manufacturing facility of Tubilux Pharma. It specializes in solutions, suspensions, gels, ointments and lyophilizates for ophthalmic pharmaceuticals (human and veterinary) and medical devices (lacrimal fluid supplements).

Certifications:
GMP Plant – Approved for aseptically prepared semisolids, small volume liquids and lyophilizates | Italian Ministry of Health (veterinary drugs)
Extra-EU Approvals: FDA (USA), ANVISA (Brazil), TGA (Australia), TMMDA (Turkey), Belarus, Russia

2024 Production Volumes:
• 23 million bottles
• 8,5 million tubes

Main Sectors:
Ophthalmic | Otological

Primary Packaging Formats:
Preservative-free multidose bottles | Multidose bottles | Glass bottles for lyophilizates | Aluminium tubes | Polyfoil tubes with tamper-evidence dispenser

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Certifications

• EMA (EU GMP)
• FDA (cGMP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• TITCK (Turkish Health Authorities)

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Activity

• Sterile forms (ophtalmic, nasal, otic), Fill&Finish, Bottles, Ophtalmic dispensers, Tubes, FDF / DRUG PRODUCTS, SERVICES manufacturing

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Features

• Uses: Commercial (Phase IV), Human, Veterinary
• Toxicity (OEB classification): N/A
• DEA: N/A
• BSL: N/A
• Therapeutic areas: (S) Sensory organs
• Markets: FDA (USA), EMA (EU), TGA (Australia), ANVISA (Brazil), Russian Health Authorities

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Batch Size / Reactor

• Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, Tech transfer, Pilot plant, Lyophilization, Scale-up, Pilot batches, Batch records, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Storage, CTD/eCTD compilation and submission

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