Solids & CTS
Göttingen
Centre of excellence for any conventional solid forms manufactured and packed within the NextPharma group.
NextPharma Göttingen has extensive experience in the manufacturing of solid dosage forms. The Göttingen site is a centre of excellence for any conventional solid forms manufactured and packed within the NextPharma group. The site was completely refurbished in 2007 and additional major extensions have been finalised in 2020 to continue to increase our capacity and services to become a leading CMO site for solid dosage forms in Europe.
The core competences are the manufacturing and packaging of granules, tablets, film coated tablets, hard gelatine capsules as well as sachets.
NextPharma Göttingen is the main location for clinical trials services.
The following services are offered
Pharmaceutical Development
- Pharmaceutical formulation development
- Scale-up (pilot-scale, production-scale)
- Validation
- Manufacturing of stability batches
- Galenic optimisation of existing formulae
- Registration services
Analytics
- Analytical development
- Validation
- Stability testing / storage
- Quality control
- Market release
Microbiology
- Testing and consultation according to customer requirements
- Hygiene monitoring at the customers' locations
- Preservative stress testing
- Microbiological evaluation
Clinical Trials Services
- Manufacturing and packaging including randomisation lists, emergency letters
- Specialties: blister cards, over-encapsulation
- Distribution
Commercial Manufacturing and Packaging
Mixing/Blending | 2,000 tonnes |
Granulation | 1,700 tonnes |
Tabletting | 4,000m tablets |
Coating | 1,200m tablets |
Blistering | 225m blisters |
Sacheting | 35m sachets |
Bottling | 15m bottles |
Filling in glass bottles | 8m bottles |
Manufacturing | 5,600 m² |
Regulatory status | Anvisa (Brazil), EMA, FDA (USA), audited by Russian authorities |
Site contact information
Address
NextPharma
Hildebrandstr. 12
D-37081 Göttingen
Germany
Phone
Fax
+49-551-382-470