Commercial Manufacturing at NextPharma Limay and Waltrop

If your product is a cream, gel, ointment, suppository, oral solution, emulsion, suspension, syrup or spray requiring commercial manufacturing, NextPharma operates two dedicated sites: Limay in France and Waltrop in Germany. Both run under EU GMP with international regulatory approvals and integrated development capabilities on site. The two sites are complementary: NextPharma Limay is built for high-volume liquid and suppository production, NextPharma Waltrop for semi-solids and liquids for hormonal and non-hormonal products in segregated manufacturing areas.

Dosage Forms and Technologies Covered

Across both sites, the following forms are in routine commercial production:

Non-sterile liquids: aqueous and organic solvent-based solutions, suspensions, emulsions and syrups in bottles
Glass ampoules (non sterile): double-point glass ampoules including nitrogen purging
Semi-solids: creams, gels and ointments, hormonal and non-hormonal, packaged in aluminium tubes or metered-dose pumps; stick packs for hormonal products
Suppositories and pessaries: hormonal and non-hormonal, with dedicated equipment and controlled heating/cooling
Sprays: nasal, buccal and topical
Mouthwash & shampoos

NextPharma Limay (France): Liquids, Ampoules and Suppositories

With over 60 years of pharmaceutical manufacturing history and more than 20 years of CDMO experience within NextPharma, Limay is the group’s Centre of Excellence for high-volume non-sterile liquid and suppository production. Located approximately 45 minutes from Paris, the site is designed for high-volume output across pharmaceutical, medical device and health and nutrition products.

Key manufacturing capabilities at NextPharma Limay:

Fully traceable, PLC-controlled compounding across the complete liquids range: syrups, solutions, suspensions and emulsions
Dedicated Ex-proof area for organic solvent-based products
Established expertise in double-point glass ampoule production, including nitrogen purging and secondary packaging in trays and blister packs
Controlled substances: dedicated manufacturing area with segregated storage at 2 to 8 °C
Integrated analytical services: multiple HPLC and GC systems, atomic absorption spectrophotometry and an in-house microbiology laboratory
Online serialisation (Mark and Verify) and tamper-evidence

NextPharma Waltrop (Germany): Hormonal and Non-Hormonal Semi-Solids and Liquids

Operating since 1928 and part of NextPharma since 2000, NextPharma Waltrop is the network’s Centre of Excellence for hormonal semi-solids products. Hormone manufacturing runs in fully segregated, dedicated areas. Non-hormonal semi-solids and liquids are produced in fully segregated areas on the same campus.

Key capabilities at NextPharma Waltrop

Semi-solids: creams, gels and ointments, hormonal and non-hormonal, packaged in aluminium tubes and metered-dose pumps; stick packs for hormonal products
Suppositories for hormonal products
Oral and topical liquids: solutions, suspensions and emulsions filled in glass or plastic bottles and pump sprays
Homogenisation and Ex-proof processing for semi-solids and liquids
Online serialisation (Mark and Verify) and tamper-evidence

From Feasibility to Commercial Supply

Development and transfer are fully integrated at both sites, across a defined sequence:

Pre-formulation: API compatibility and early stability
Analytical development: method development, validation and transfer
Formulation development for liquids and semi-solids, galenical optimisation and paediatric formulations at NextPharma Waltrop
Process development and scale-up
Stability: ICH studies at NextPharma Limay across zones II and IVb, five temperature and humidity conditions
Industrialisation: validation, technology transfer and CTD Module 3 registration services at NextPharma Waltrop

For creams, gels, ointments and liquids, batch-to-batch consistency is decided by the compounding and homogenisation conditions: mixing speed and sequence, temperature profile, and the point at which each phase is added. These determine texture, viscosity and whether an emulsion stays stable across shelf life. Moving a product to another manufacturer means re-establishing all of them and re-running the stability programme that demonstrates the result. NextPharma Limay and NextPharma Waltrop each combine formulation development, analytical development, stability testing and commercial manufacture on a single site, so the parameters set during development carry into production batches directly.

Quality and Compliance

Both sites operate under EU GMP and are inspected by multiple international health authorities.

Site	Regulatory Coverage
Limay	ANSM (routine inspections), ANVISA, FDA requirements applied to health and nutrition products; EcoVadis Gold and PSCI certified; carbon neutral for Scope 1 and 2. Recognised within France’s strategic industrial development initiatives as a contributor to European pharmaceutical sovereignty
Waltrop	FDA, EMA, ANVISA; GMP Compliance Certificate issued by BezReg Münster; additionally inspected by Korean, Taiwanese, Turkish and Russian authorities

For a full overview of commercial manufacturing and packaging capabilities across the NextPharma network, including solid dose, softgels and ophthalmics, see the service 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.

Discuss Your Semi-Solids or Liquids Programme

Manufacturing capacity and development scope at NextPharma Limay and NextPharma Waltrop are confirmed product by product. Share your dosage form, target markets, batch size requirements and development stage, and we will identify the right site and contacts for your programme.

Talk to our semi-solids and liquids manufacturing team

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Discuss your Pharmaceutical Development programme

Share your API, dosage form strategy and clinical or commercial timelines with our development team. We will confirm technical fit, outline the development pathway and identify the relevant specialist sites for your programme.

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Semi-Solids & Non-Sterile Liquids