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Oral Solid Dosage

Services
Oral Solid Dosage

Commercial Manufacturing at NextPharma Bielefeld, Göttingen and Asker

Three sites anchor NextPharma’s solid oral dose network: NextPharma Bielefeld for modified-release pellet solid forms, NextPharma Göttingen for high-volume oral solids and NextPharma Asker for large-volume immediate-release tablets and chewable tablets. Each site combines pharmaceutical development with commercial manufacture, so process parameters established during formulation carry directly into production batches. If your programme involves standard or complex solid oral forms at mid- to large-volume scale, this page maps which site fits which product type.

01

Dosage Forms and Technologies Covered

Across the three primary sites, the solid oral portfolio includes:

  • Tablets: compressed powder, granule and pellet tablets; film-coated tablets; bi-layer tablets; orodispersible and mini-tablets; modified-release matrix tablets; chewable tablets

  • Capsules: hard capsules with single and double filling, including pellets, powder, granules, tablets and combinations in one capsule

  • Multiparticulates and modified release: pellets by extrusion/spheronisation and layering; film coating (aqueous and organic) for taste-masking, gastro-resistance, modified release and API protection

  • Powders and granules: dry syrups, powders for suspension, sachets and stick packs

02

NextPharma Göttingen: High-Volume Oral Solids and Clinical Supply

NextPharma Göttingen covers blending, granulation, tabletting (including bi-layer), coating, hard-capsule encapsulation and packaging in blisters, bottles and sachets capability. Development, analytics, microbiology and QP release are all available on site. The same site also serves as NextPharma’s principal Clinical Trials Services hub, which means development-stage and commercial-stage solid oral programmes can run in parallel without a site change.

03

NextPharma Bielefeld: Modified Release and Pellet Solid Forms

Pellet solid forms whose release profile depends on multiparticulate and coating expertise belong at NextPharma Bielefeld. The site has focused on modified-release technology for over 30 years, running pellet production by extrusion and spheronisation, layering, aqueous and organic film coating, encapsulation including double filling, and tabletting of pellets. Packaging in blisters and stick packs is available on site.

NextPharma Bielefeld is also the analytical Centre of Excellence for the network, with dissolution testing to USP methods 1 to 3 (online and offline), UHPLC, HPLC and GC on site. Keeping release-profile testing and MR manufacture in the same facility shortens the loop between a coating adjustment and its analytical result. More details on modified-release capabilities are available on the NextPharma Bielefeld location page.

04

NextPharma Asker: High-Volume Immediate-Release Tablets and Chewable Tablets

High-volume chewable tablet manufacturing is a differentiator within the NextPharma network, and a capability few European CDMOs run at commercial scale. NextPharma Asker is built around it: fluid-bed granulation, in-house flavour granulate production and a highly automated, lean production flow designed for high-volume output across nutritional, OTC and Rx products. The site holds specific expertise in calcium/vitamin D3 chewable tablets, with in-house flavour development and a trained sensory panel operating to ISO guidelines. The calcium/vitamin D3 portfolio is registered in approximately 50 markets worldwide. Batch sizes in blending, compression and packaging reach approximately 4 tonnes.

05

From Feasibility to Commercial Supply

Each of the three sites takes a solid oral programme through the same defined sequence, without a site change:

  1. Pre-formulation: API characterisation, excipient compatibility and early stability

  2. Analytical development: method development, validation and transfer

  3. Formulation and galenic optimisation

  4. Process development and scale-up from pilot to production

  5. Clinical supplies: production of clinical batches under GMP — NextPharma Göttingen is the group’s principal Clinical Trials Services site

  6. Industrialisation: registration batches, validation, stability batches and registration support

Each site integrates formulation development, scale-up from pilot to production, validation, stability batches, galenic optimisation and registration support with commercial manufacture. For complex modified-release forms in particular, keeping formulation, coating and commercial manufacture within the same environment avoids the re-establishment of coating conditions that a site-to-site transfer would require.

Quality and Compliance

Site

Regulatory Coverage
Bielefeld EU GMP; FDA-approved analytical services; additional national authorities
Göttingen EU GMP, FDA, ANVISA and additional national authorities
Asker EU GMP and additional national authorities

All three sites named on this page accept regular customer audits.

Solid oral forms are also produced at two NextPharma sites outside the scope of this page: NextPharma Berlin for penicillin-type beta-lactam antibiotics, covering human, veterinary and paediatric indications, and NextPharma Waltrop for hormonal solids alongside its semi-solids and liquids capabilities. For the full picture, see the Commercial Manufacturing and Packaging hub.

Commercial sites network and capabilities

Commercial activities are supported by specialist centres of excellence across Europe, each aligned to specific technologies and dosage forms.

Berlin

Discuss Your Solid Oral Programme

Format, volume, release profile and target markets determine which site and which process route fits your product. Share those details with our team and we will confirm the right manufacturing location and connect you with the relevant contacts.

Talk to our solid dose manufacturing team
Commercial Manufacturing & Packaging
Pharmaceutical Development
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Clinical Trials Services
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