Adragos Pharma | Maisons-Alfort

Adragos Pharma | Maisons-Alfort

Specialised in prefilled syringes, liquid and lyophilised vials, it combines advanced aseptic filling, freeze-drying, and inspection systems.

About the plant

With over 77 years of specialization in sterile drug manufacturing, the Maisons-Alfort facility is a global hub for prefilled syringes (PFS), liquid and lyophilised vials, featuring high-speed aseptic filling, large-scale freeze-drying, and advanced inspection systems. It operates under stringent GMP standards with CIP/SIP and RABS technologies.

 

Pre-Filled Syringes (PFS)

Technology

Two filling lines with RABS technology.

3 types of PFS:

• Standard
• Preventis
• Eris

Capacity

• Maximum Capacity: up to 540 syringes/min.
• 150 million units per year.
• Format: 0,5 mL and 1 mL.

Inspection

• 2 Seidenader lines 100% automated.
• Max capacity: up to 600 syringes/min.

Packaging

• 5 thermoforming packaging lines.
• 1 packaging plastic-free line.
• Speed: up to 360 syringes/min.
• Kit formats: 2- to 76-syringe packs, including Blister-to-Box (BIB) options.

 

Vials Liquid & Lyo

Technology:

• 1 filling line with RABS technology
• 2 large automated loading/unloading freeze dryers

Capacity

• Maximum Capacity: up to 6 million vials
• Filling: up to 300 vials/min
• Freeze-drying: up to 70,000 vials
• Crimping: up to 350 vials/min
• Format: 6R, 10R, 7 mL, 10 mL, 15 mL, 22 mL

Inspection

• Semi-automated inspection
• Max capacity: up to 100 vials/min

Packaging

• 1 plastic-free packaging line for vials with solvent ampoules
• 1 blister line for combinated vial kits with BIB options
• Cartooning box: up to 130 vials/min
• Thermoforming machine: up to 75 blisters/min for combined kits

Large storage capacity through internal and external warehouse models to ensure continuity of supply and scale-up flexibility, with GMP-qualified warehouse processes, temperature mapping, and continuous temperature monitoring.

---

Compliance

• EMA (EU GMP)
• NMPA (China GMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• MFDS/KFDA (Republic of Korea GMP)
• SFDA (Saudi Food & Drug Authority)
• TITCK (Turkish Health Authorities)

---

Activity

• Injectables, Fill&Finish, Small volume vials, PFS (Prefilled Syringes), FDF / DRUG PRODUCTS manufacturing

---

Features

• Uses: Commercial (Phase IV), Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
• Controlled substance: Lowest potential for abuse
• BSL: 1
• Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V04) Diagnostic agents, (V01) Allergens
• Markets: EMA (EU), NMPA (China), ANVISA (Brazil), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

---

Batch Size / Reactor

• Large

---

Services

• Regulatory services, Manufacturing services, Analytical / QC services, Packaging, Tech transfer, Lyophilization, Engineering batches, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, Primary packaging, Secondary packaging, Labeling, Serialization, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, Physicochemical characterization, Water content (KF), Nitrosamines (HPLC-MS/MS), Endotoxins (LAL)

---