GMP manufacturing of non-sterile dosage forms

Liquids and semi-solids manufacturing up to 50kg

We operate two GMP manufacturing platforms: 

• A 10 kg compounding tank with a 5 kg melting vessel.
• A 50kg compounding tank with a 25 kg melting vessel.

These platforms allow manufacturing of creams, gels, ointments, lotions, solutions and suspensions. We provide primary packaging services, including filling into amber glass bottles, plastic bottles, aluminum tubes and plastic tubes. 

Nuvisan offers 390 m² of cGMP facilities, with four manufacturing rooms, three filling rooms, an in-process control laboratory and a dedicated cleaning area. All these rooms are monitored in temperature, relative humidity (hygrometry) and pressure. Our facilities are designed for the safe handling of highly potent APIs (OEL >1 µg/m³) and botanical materials. 

Capsules manufacturing

Nuvisan provides manual encapsulation for early-phase development, preparing capsule formulations using HPMC or gelatine capsule shells. Capsules are filled with drug substances or with excipient, utilising a capsule board for simple formulations. Activities cover compatibility studies (API and excipients), scale-up batches, stability studies and internal pharmaceutical analytical support. Services also include over-encapsulation for clinical or home administration.

Powder in bottles 

Powder in bottle: This option is suitable when the API is soluble in water, the administration volume is acceptable and administration is conducted at the clinic. Nuvisan manages the development of the reconstitution procedure and in-use stability studies. 

Two-bottle system: This option is suitable when administration occurs at the clinic and additional excipients are required for API solubilisation or suspension. Nuvisan manages the development of the diluent, including stability, the development of the reconstitution procedure and in-use stability studies.