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Sourcing Inquiry Logo Indena S.p.A.

Indena S.p.A.

Regions
Europe
Countries
Italy
Size
n.e.
Specialty
Biopharmaceuticals, Nutraceuticals
Service category
Contract manufacturing, filling and packaging, Partnering/collaboration for drug dossiers, patents, drug candidates, medical technology
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Key services

Services

Partnership

Indena Contract Manufacturing services for the extraction, isolation and purification of natural derivatives include a full range of manufacturing capabilities for food and pharma grade ingredients on a wide range of scales.

 

The combination of Indena’s expertise and state-of-the-art facilities delivers products and processes from small scale to large commercial manufacturing operations.

 

Indena’s R&D center is in Italy, while the production units are in Italy, Settala and Palestro, France and India.

 

Indena’s facilities incorporate separate authorised areas for handling pharma and food grade natural derivates, and the Quality System ensures compliance with cGMP and Hazard Analysis and Crytical Control Points (HACCP) guidelines.

 

Plants for Plants

Indena Contract Manufacturing services for the extraction, isolation and purification of natural derivatives include a full range of manufacturing capabilities for food and pharma grade ingredients on a wide range of scales.

 

The combination of Indena’s expertise and state-of-the-art facilities delivers products and processes from small scale to large commercial manufacturing operations.

 

Indena’s R&D center is in Italy, while the production units are in Italy, Settala and Palestro, France and India.

 

Indena’s facilities incorporate separate authorised areas for handling pharma and food grade natural derivates, and the Quality System ensures compliance with cGMP and Hazard Analysis and Crytical Control Points (HACCP) guidelines.

 

Cytotoxics and HPAIs

Indena HPAIs contract manufacturing services include a full range of high-power manufacturing capabilities for active pharmaceutical ingredients on a wide range of scales.

 

The combination of Indena’s expertise and top class facilities delivers products and processes from small scale GLP batches for toxicology, cGMP batches for clinical trials to large-scale commercial manufacturing.

 

Indena’s Highly Potent Contract Manufacturing site is in Settala (Italy) and meets US-FDA, ICH and EU requirements. This facility incorporates appropriate room pressurization, airlocks, ventilation and isolators to properly handle highly potent solids and liquids up to 0.1 μg/m3 OEL (Class 4).

 

Indena 30

Indena 30® is the name given to the quality system developed by the company. It is based on more than 30 checks covering the entire production cycle, from incoming raw materials to the finished product.

 

The system allows Indena to guarantee the safety, consistency and traceability of each batch. Product quality is monitored through all production stages, which comply with the rigorous Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP), as well as observing the Hazard Analysis Critical Control Points (HACCP).

 

Indena is also committed to continual improvement in Quality Assurance (QA) and to this end has always worked alongside the regulatory authorities for the sector. Every process that affects product quality is meticulously documented and the information made available for assessment by customers as well by the regulatory authorities. Indena’s own research team is constantly developing new analytical methods to ensure that products are of high quality and that pharmacopoeias are supplied with the most appropriate means of characterising them.

 

Approvals, Certificates, Authorisations

  • ISO 14001

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