Customer Newsletter
Issue 2/09
Welcome to the NextPharma Newsletter
In this edition of our Newsletter I am pleased to highlight some significant advancements at our Waltrop facility in Germany.
The site received a successful FDA Inspection last year which covered activities associated with Product Development and Contract Manufacturing Services. The outcome of the assessment highlighted confidence in the site team and the supporting Quality system. It also confirmed that the approach to facility qualification and risk management was in line with FDA thinking.
Waltrop has a long established reputation for its expertise in the production and packaging of both semi-solids (gels, creams and ointments) and of hormonal solids (primarily oral contraceptives) and is now bringing these two technologies together with an expanded manufacturing capability to include the production and packaging of hormonal semi-solids.
These advancements demonstrate how Waltrop’s expertise and capabilities have evolved and we are pleased to be able to offer these additional products, expertise and services to current and potential new customers.
NextPharma Waltrop also has considerable know-how in the manufacturing and packaging of oral contraceptives (OCs) in dedicated areas. In addition, as back-up for NextPharma’s Bielefeld facility Waltrop can also offer film-coating of pellets and offers storage, handling and dispatching of controlled substances in modern temperature controlled and high-security warehouses.
Additionally, because Waltrop has a controlled drugs warehouse and handling permission it can do production, packaging and distribution of controlled drugs for liquids and semisolids.
To find out more about how NextPharma can meet our outsourcing needs please contact us on the numbers below:
With kind regards,
Bill Wedlake
CEO, NextPharma
Services & Capabilities Waltrop
Production (capacity p.a.)
Centre of Excellence for Hormones and Steroids
| Oral and topical liquids | 600,000 litres | |
| Filling and cartoning of oral and topical liquids | 7 million | |
| Semi-solids | 150 tons | |
| Packaging in tubes (aluminium + plastic) | 5 million | |
| Hormone tablets and film coated tablets | 1.2 billion | |
| Flow packs (alu sachet for blister) | 54 million | |
| Blisters | 150 million | |
| incl. PP blisters | 20 million | |
| incl. blisters with hormone solids | 50 million | |
| Final packs solids | 60 million | |
| Pellet coating | 90 tons |
Product Development Services
- Hormones, steroidal solids and oral and topical liquid/semi-solids
- Analytical and stability studies for products
- Clinical materials preparation and packaging for liquids, semi-solids and hormonal solids
Specific expertise exists in bulk manufacturing and packaging for sexual hormones (e.g. oral contraceptives)
Cold Chain and Logistics Services
Key Figures
| Site Area | 48,650 sqm |
| Built-up Area | 9,826 sqm |
| GMP Production Area | 4,100 sqm |
| Quality Laboratories | 360 sqm |
| Warehouse Capacity | 2,500 pallet places |
| Goods Arrival / Dispatch Area | 1,500 sqm |
| Administration | 600 sqm |


