Our manufacturing site Medinsa is a centre of excellence for the development and manufacture of modified-release products, narcotic drugs and capsule products. The plant is located on the outskirts of Madrid, 20 minutes from the airport and 18 km from the city centre!
In the segment of oral solids, we offer nearly all the requested equipment incl. a dedicated area for effervescent tablets. A strong investment has been made in recent years in order to cover technologies like pellet coating and extrusion/spheronisation of pellets, micro-tableting and organic-solvent granulation and layering.
In the field of method development and analytics, we use highly sophisticated equipment and the latest chromatographic data software, which is full-featured and GMP-compliant and allows workflow enhancements that will help to improve our processes and methods. As an important complementary service to the pharmaceutical development activities, the supply of clinical trial material is part of our service portfolio.
Besides all development activities within Aristo Pharma, Medinsa has an excellent dedicated facility for product development services – a state-of-the-art pilot plant that is 100% scalable to industrial-size equipment by using the same technologies and equipment for both, the pilot and industrial plant. This development plant is a reference in its class in the CDMO environment and shows our clients the importance and professionality of development services within our Group.
The packaging lines are equipped with devices that support anti-counterfeiting and serialisation. Lidding foils can be printed on demand on-site in order to increase flexibility and competitiveness.
Apart from the GMP certification for medical products for human and veterinary use, we have received the narcotics licence issued by the Spanish health authorities.
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Facts
- Number of employees: 267
- Production area: 6,300 m²
- Development facilities: 1,115 m²
- Finished-product output: 18,3 million per year
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Dosage forms
- Tablet formulations
- ODT
- Effervescent tablets
- Tablets / film-coated tablets / sugar-coated tablets
- Micro-tablets
- MUPS
- Capsule formulations
- Powder
- Micro-tablets
- Powder + tablets
- Pellets
- Multi-particulate formulations
- Powder-layered pellets
- Liquid-layered pellets
- Extruded pellets
- Micro-tablets
- Tablet formulations
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Packaging activities
- Blister thermo-films/ aluminium cold forming
- Bottle plastic and glass
- Plastic and aluminium tubes with or without desiccant cap
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Capacities
- Granulate: 530 tons
- Extrudate: 130 tons
- Pellet coating: 440 tons
- Micro-tablets: 2.5 billion tablets
- Capsules: 1,1 billion
- Tablets: 1 billion incl. effervescent tablets
- Coating: 130 tons
- Blister: 100 million
- Strips: 26 million
- Tubes: 11 million
- Bottles: 5 million
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Pharmaceutical development activities
- API, comparator, excipient sourcing and testing
- Formulation development
- Manufacture, packaging and distribution of clinical supplies
- Scale-up and process development
- Process validation
- Cleaning validation
- Analytical method development
- Analytical control for raw materials, bulk and finished products
- Stability storage and testing
- Analytical method validation
- Release by qualified person
