Locations

Waltrop, Germany

Hormones and Semi-Solids Manufacturing
Locations
Waltrop, Germany
Hormones and Semi-Solids Manufacturing

NextPharma Waltrop: Hormones and Semi-Solids Manufacturing Centre of Excellence

NextPharma Waltrop, operating as Pharbil Pharma GmbH, is the group’s dedicated Centre of Excellence for hormone and semi-solid pharmaceutical manufacturing.

If you are evaluating a European CDMO for hormone, semi-solid or liquid development and production, discover Waltrop’s core capabilities, regulatory status, facility details, and how to start a conversation with the team.

The site

Primary Capabilities

The Waltrop site has been part of the NextPharma Group since 2000. It is purpose-built for the development, commercial manufacturing, packaging and quality control of hormonal products, produced in segregated dedicated areas.

Our annual capacities include 1.8 billion hormone tablets and 400 tons of semi-solids across hormonal and non-hormonal creams, gels and ointments. Our core technology platforms cover fluid bed granulation, tablet compression and coating for solid dose, homogenisation and ex-proof processing for semi-solids,  as well as solution, suspension and emulsion manufacturing for non-sterile liquids. We cover the following core dosage forms: 

Core dosage forms

Hormone tablets (film-coated and uncoated)

Standart immediate release

Creams, gels and ointments (hormonal and non-hormonal)

Standart immediate release

Oral and topical liquids

Standart immediate release

Flavour and development on site

Packaging options include PVC, PVDC and Aclar blisters and flow packs for solid dose,  as well as aluminium tubes,pump dispensers and stick packs for semi-solids.  

Development is fully integrated into the site: pharmaceutical formulation development, galenical optimisation, paediatric formulations, pilot- and production scale-up, validation, stability studies, analytical development and CTD Module 3 registration services are all available at NextPharma Waltrop, supporting programs from early formulation to commercial manufacture and market release. 

SERVICES

Additional capabilities

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

01

Oral and topical liquids: Solutions, suspensions, emulsions in glass or plastic bottles and pump dispensers

02

Semi-solids: Creams, gels, ointments in aluminium tubes, metered dose bottles, stick packs as well as suppositories

03

Clinical trial supplies: Manufacturing and packaging for CTS across liquids, solids and semi-solids

04

Paediatric formulations

For hormone and semi-solid manufacturing capabilities, see our hormones manufacturing services and semi-solids and liquids services.

Regulatory status

Quality and compliance

Production at NextPharma Waltrop operates, amongst others, under FDA, EMA and ANVISA requirements. The site holds a GMP Compliance Certificate issued by BezReg Münster and a manufacturing licence and has been inspected by multiple additional national authorities including Korean, Taiwanese, Turkish and Russian agencies.

EMA

European Medicines Agency

FDA

United States Food and Drug Asministration

ANVISA

National Health Surveillance Agency

Site & infrastructure

Facility

The NextPharma Waltrop site covers 48,650 m² of land with 9,800 m² of built area, including 4,300 m² of manufacturing space and 360 m² of laboratory space. Warehousing supports 3,650 pallet places for raw materials. The facility maintains dedicated hormone and non-hormone production and packaging areas, with ex-proof processing environments across semi-solid and liquid manufacturing. For an overview of all our sites, visit the NextPharma locations hub.

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Talk to the Waltrop Team
To discuss hormone or semi-solid manufacturing capacity, development projects at Waltrop, contact us directly:

Address

Pharbil Waltrop GmbH, part of NextPharma Im Wirrigen 25, D-45731 Waltrop, Germany

Telephone

+49-2309-9375-0

Email

info@nextpharma.com

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