Oral Solid Dose Manufacturing and Clinical Trial Services

Locations

Göttingen, Germany

Oral Solid Dose Manufacturing and Clinical Trial Service

Locations

Göttingen, Germany

NextPharma Göttingen: Oral Solid Dose (OSD) Manufacturing and Clinical Trial Services (CTS) Centre of Excellence

NextPharma Göttingen’s site, operating as allphamed Pharbil Arzneimittel GmbH, is the group’s Centre of Excellence for the manufacture of oral solid dosage forms and clinical trial services. It is a purpose-built for high-volume productionsand can also handle specialist capabilities in complex packaging, orphan drug batches, and controlled substances for investigational medicinal products (IMPs).

If you are evaluating a European CDMO for solid dose manufacturing or clinical trial supply, discover NextPharma Göttingen’s core capabilities, regulatory status, facility details, and how to start a conversation with the team.

The site

Primary capabilities

The Göttingen site has been part of the NextPharma Group since 2000. It is purpose-built for high-volume oral solid dose manufacturing and is the group’s principal site for clinical trial services.

Our core technology platforms cover the following dosage forms:

Core dosage forms

Bi-layer tablets

Standart immediate release

Sachets

Standart immediate release

Tablets and capsules in blisters

Standart immediate release

Tablets and capsules in bottles

Standart immediate release

Flavour and development on site

Development is fully integrated into the site: formulation development, process development, scale-up, analytical method development and validation, stability testing, technology transfer and microbiology are all available at NextPharma Göttingen, supporting programmes from early-stage formulation through to high volume commercial market supply.

Clinical Trial Services

Our Clinical Trial Services support the complete supply chain for clinical studies, from early-phase development through global Phase III trials. Services include:

Manufacturing support (matching placebo production, blister card production, over-encapsulation and blinding)

Secondary packaging for all pharmaceutical dosage forms including OSD, vials, syringes, pre-filled syringes, auto-injectors, pens, semi solidsand liquids

Labelling and re-labelling

Kit assembly

Randomisation and trial supply management

Emergency code-break letters

Returns and reconciliation

Storage under different controlled temperature conditions

Worldwide distribution

EU-QP release

SERVICES

Additional capabilities

NextPharma Göttingen offers a unique combination of specialised pharmaceutical capabilities, making the site a trusted partner for a wide range of the following related services:

01

Bi-layer tableting: 200 million units per year capacity

02

Sachets: Packaging of powders and granules

03

Bottle filling: High-performance lines for tablets and capsules in bottles (20 million units per year)

04

Microbiology: Testing and consultation, hygiene monitoring, preservative stress testing, microbiological evaluation

05

Contract analytics: Method development, validation and transfer, stability studies, QP release, over 25 years of analytical services experience

06

IOR, translation service, UK QP IMP Oversight

07

Comparator sourcing for clinical trial activities

08

ODP (Orphan Drug Packaging) for small and ultra-small commercial batches for rare diseases

09

Controlled substance IMP production, packaging, storage and shipment

For clinical trial supply services, see our clinical trials services. For solid dose manufacturing capabilities, explore our solid dose services. For analytical and microbiological services, see our analytical and microbiological services.

Regulatory status

Quality and compliance

Production at NextPharma Göttingen operates, amongst others, under EU GMP, FDA, ANSM and ANVISA requirements and has also successfully been inspected by by Russian, Belarusian and Kenyan regulatory bodies.

Site & infrastructure

Facility

The NextPharma Göttingen site covers 22,965 m² of land with 8,580 m² of built area, including 5,600 m² of GMP production space, 1,130 m² of laboratories, 600 m² of clinical trial services area, and 200 m² of development space. Warehousing supports 12,440 pallet places, including 8,000 external pallet places, with a reserved building area of 600 m² available for future expansion. The site was completely refurbished between 2005 and 2007 and substantially expanded between 2019 and 2021 with additional bulk equipment and packaging lines. For an overview of all our sites, visit the NextPharma locations hub.