For the full range of softgel, see our softgel manufacturing services. For products containing HPAPIs , explore our HPAPI services.
With 30 years of formulation expertise in lipid-based dosage forms, NextPharma’s Ploërmel site, operating as NextPharma Ploërmel SAS,is the group’s Centre of Excellence for lipid-based formulation manufacturing with dedicated capabilities in softgel and vegan soft capsules, liquid-filled hard capsules, with capabilities to handle conventional APIs, hormonal APIs and high-potent APIs for pharmaceuticaland health and nutrition markets. Microdosing capabilities of APIs into hard capsules are available as well.
If you are evaluating a European CDMO for softgel or lipid-based capsule manufacturing, discover NextPharma Ploërmel’s core capabilities, regulatory status, facility details, and how to start a conversation with the team.
The NextPharma Ploërmel site has been part of the NextPharma Group since 2021. The Ploërmel site is purpose-built for softgel capsule and liquid-filled hard capsule manufacturing across pharmaceutical, hormonal and health and nutrition applications.
Our core expertise covers development and manufacturing of SEDDS and SMEDDS formulations, including in vitro performance evaluation by lipolysis and micro-dissolution in the following core dosage forms:
Softgel capsules
Liquid-filled hard capsules (LFHC) with Licaps technology
Powder-in-capsule for microdosing
Next to large-scale commercial manufacturing, Development is deeply integrated into the site. A team of almost 30 technicians, engineers, pharmacists and PhDs covers formulation development, process development, analytical method development and validation, stability studies, tech transfer, clinical and registration batch manufacturing, and CTD documentation, supporting programmes from early feasibility through to commercial scale-up. We develop products from pre-formulation to commercial scale, including clinical trial materials from Phase I to Phase III.
Liquid-filled hard capsules (LFHC) with Licaps technology
Powder in capsule / microdosing: 3 GMP encapsulation lines with 100% mass control from 0.1 mg to 200 mg, mainly for clinical supply. Enables fast first-in-human processes by directly filling capsules with pure API, without complex formulation and analytical development steps. Clinical samples can be supplied within four months of project start. OEB1 to OEB5.
Fast-in-human studies: Phase I,Phase II and Phase III clinical supplies
Microdosing: Powder in capsules
Quality control: HPLC/UPLC systems, GC headspace systems, in vitro dissolution (USP types 1, 2 and 3), dedicated high-potent handling area
For the full range of softgel, see our softgel manufacturing services. For products containing HPAPIs , explore our HPAPI services.
Production at NextPharma Ploërmel operates under, amongst others, ANSM (France/EU), FDA and ANVISA requirements. The site holds a pharmaceutical manufacturing licence, current EU GMP certificates for both human medicinal products and investigational medicinal products. The site holds ISO 50001 energy management certification, obtained in 2022.
The NextPharma Ploërmel site spans 57,000 m² of land with 15,000 m² of built area, including 5,550 m² of GMP floor space. Warehousing provides 2,500 pallet places for raw materials and 1,250 pallet places for finished products. The facility comprises dedicated pharmaceutical, hormonal and health and nutrition production units, each equipped with a 1,000-litre mixer.
On-site blister packaging capabilities will be available by 2027. This will add a fully integrated end-to-end service at NextPharma Ploërmel, from encapsulation and filling through to finished, blister-packed product, all on a single site.
For an overview of all our manufacturing sites, visit the NextPharma locations hub. For the full range of services across the network, see our services overview.
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