Aenova Group - Location Latina, Italy

Aenova Group - Location Latina, Italy

Competence Center animal health products and sterile technologies.

About the plant

The Aenova site in Latina produces and distributes pharmaceutical products over the world for human and veterinary use. Covered business segments are

• - F&F of Biologics and Small Molecules
• - Betalactam Sterile Fillings
• - Penicillins Oral Solids
• - Conventional Oral Solids
• - Oral Solid Parasiticides

With many strategic investments we enhance capacity and capabilities in the site, e.g. with the new Fill&Finish Suite for PFS and Vials for small molecules API and large molecules Biologics. The site in Latina is one of the largest production facilities of the Aenova Group.

More information here: Aenova Group

---

Certifications

• EMA (EU GMP)
• FDA (cGMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• SFDA (Saudi Food & Drug Authority)
• TITCK (Turkish Health Authorities)

---

Activity

• Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Injectables, Tablets, Hard capsules, Powders, Lozenges, Terminal sterilization, Fill&Finish, Bottles, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), FDF / DRUG PRODUCTS, BIOLOGICS manufacturing

---

Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
• DEA: N/A
• BSL: 1, 2
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

---

Batch Size / Reactor

• Small, Medium, Large

---

Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, R&D, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Fill&Finish, Sterile product manufacturing, Tech transfer, Engineering batches, Analytical methods development, Batch certification / release, Primary packaging, Secondary packaging, Labeling, Serialization, CMC regulatory support

---