Contract manufacturing of liquid and semi-solid pharmaceuticals as well as suppositories in compliance with GMP at the Ettlingen site
W. Spitzner Arzneimittelfabrik GmbH
Ettlingen (DE)New on Amplifa
About Spitzner
W. Spitzner Arzneimittelfabrik GmbH is a family-owned company founded in 1949 and, since 2022, once again owner-managed, based in Ettlingen in the Northern Black Forest. As a specialised CMO, the company produces liquid and semi-solid pharmaceuticals, suppositories and care products with around 80 employees on a plant area of approximately 19,000 m² — with particular expertise in the field of phytopharmaceuticals. Production takes place on vacuum process systems for semi-solid preparations, stainless steel process vessels with disperser mixers, and automated filling lines for tubes, bottles and alu-alu blister packs. The entire value chain — from galenics and production through to pharmaceutical logistics (pick & pack) — is carried out under GMP conditions at the Ettlingen site. Customers include pharmaceutical manufacturers in Germany and abroad; contract manufacturing covers batch sizes from a few kilograms up to 5,000 litres per batch. Since the 1960s, the company has also been established as a provider in the fields of physiotherapy and professional wellness in thermal spas and upscale hotels.
- Site
- Ettlingen
- Processes
- Contract manufacturing of liquid pharmaceuticals, Contract manufacturing of semi-solid pharmaceuticals, Manufacture of suppositories (Zäpfchen), Filling of semi-solid preparations into tubes (aluminium, CoEx, HDPE, laminate), Filling of liquid preparations into round and shaped bottles, Pick & pack (pharmaceutical logistics, packaging and shipping), Quality control: routine analytics, microbiology, method development and validation, Galenics, development and transfer management
- Materials
- Phytopharmaceuticals (plant extracts), Aluminium tubes, CoEx tubes, HDPE tubes, Laminate tubes, Alu-alu blister (suppositories), Liquid preparations, Semi-solid preparations
- Certificates
- EU GMP certification (human and veterinary medicines), Manufacturing licence under AMG and TAMG, Serialisation under EU FMD, EU GMP (human and veterinary medicines), Manufacturing licence under AMG/TAMG, ISO 9001
- Founded
- 1949
- Employees
- 80
- Industries
- Pharmaceutical industry
- 01
Galenics, development and transfer management
- 02
Raw material testing (quality control)
- 03
Production of liquid/semi-solid preparations
- 04
Filling into tubes, bottles, blisters or jars
- 05
Packaging (pick & pack)
- 06
Pharmaceutical logistics with shipment tracking
Galenics & Packaging Materials
Liquid preparations
Production in stainless steel process vessels (EX) with Ystral disperser mixer, 1,300–5,000 L per batch.
Semi-solid preparations
Vacuum process systems with agitator, scrapers and rotor-stator homogeniser, from approx. 50 kg minimum fill.
Phytopharmaceuticals (plant extracts)
Additional expertise in plant-based extracts as the basis for pharmaceutical and care products.
Aluminium tubes
Filling of semi-solid preparations with double, triple and saddle folds.
CoEx tubes
Plastic tubes, sealed using the hot-air method.
HDPE tubes
Plastic tubes with fill volumes from 5 g to 200 g.
Laminate tubes
Composite tubes for semi-solid preparations.
Alu-alu blister
Packaging of suppositories with easy-peel closure.
Production Site
Ettlingen
DEProduction site (GMP contract manufacturing, quality assurance, pharmaceutical logistics)
- Part weight / size
- Batches from approx. 50 kg or 1,300 L; tubes 5–200 g;
- Lot size
- 2–4 batches per shift (semi-solid); 1,300–5,000 L (liquid)
- Materials
- Liquid and semi-solid preparations, phytopharmaceuticals, suppositories
- FrymaKoruma Dinex H-1300 (EX) vacuum process system (up to 1,000 kg)
- SYMEX CML-400 vacuum process system (up to 400 kg)
- Stainless steel process vessels (EX) with Ystral disperser mixer (5,000 L)
- IWK TFS 80-2 tube filling line (up to 160 tubes/min)
- IWK TFS 20 tube filling line (up to 100 tubes/min)
- SARONG SAAS-15 suppository packaging line (approx. 30,000 units/h)
- WÜRSCHUM Touchfill (EX) semi-automatic filling machine
- RATIONATOR Robomat (EX) bottle filling line with CIP
- SAP-supported pick & pack logistics
Services
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Contract manufacturing of liquid pharmaceuticalsMontage | – | – | – | approx. 1,300 litres – 5,000 litres per batch | – |
| Contract manufacturing of semi-solid pharmaceuticalsMontage | – | – | approx. 50 kg – approx. 1,000 kg | – | – |
| Manufacture of suppositories (Zäpfchen)Montage | – | – | 1 g – 2 g | – | – |
| Filling of semi-solid preparations into tubes (aluminium, CoEx, HDPE, laminate)Montage | – | – | 5 g – 200 g | – | Aluminium, CoEx, HDPE, Laminate |
| Filling of liquid preparations into round and shaped bottlesMontage | – | – | 20 mL – 1000 mL | – | – |
| Pick & pack (pharmaceutical logistics, packaging and shipping)Montage | – | – | – | – | – |
| Quality control: routine analytics, microbiology, method development and validationPrüfung | – | – | – | – | – |
| Galenics, development and transfer managementEngineering | – | – | – | – | – |
8 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Vacuum process system for semi-solid preparations (agitator, scrapers, rotor-stator homogeniser) | FrymaKoruma Dinex H-1300 (EX) | 1 | Maximum load approx. 1,000 kg, minimum fill approx. 80 kg | – | Ettlingen |
| Vacuum process system for semi-solid preparations (agitator, scrapers, rotor-stator homogeniser) | SYMEX CML-400 | 1 | Maximum load approx. 400 kg, minimum fill approx. 50 kg | – | Ettlingen |
| Stainless steel process vessel (EX) with Ystral disperser mixer, on load cells | Ystral Disperser mixer | – | Maximum capacity 5,000 litres per batch, minimum fill volume approx. 1,300 litres | – | Ettlingen |
| Automatic tube filling line for semi-solid preparations | IWK TFS 80-2 | 1 | Tube sizes 5 g to 200 g, up to 160 tubes per minute | – | Ettlingen |
| Automatic tube filling line for semi-solid preparations | IWK TFS 20 | 1 | Tube sizes 20 g to 150 g, up to 100 tubes per minute | – | Ettlingen |
| Automated packaging line for suppositories in alu-alu blister | SARONG SAAS-15 | 1 | Tooling for 1 g and 2 g suppositories, approx. 30,000 suppositories per hour | – | Ettlingen |
| Semi-automatic filling machine (EX) for smaller batch sizes and jars | WÜRSCHUM Touchfill (EX) | 1 | 10 to 30 units per minute | – | Ettlingen |
| Automated filling line for round and shaped bottles with CIP cleaning | RATIONATOR Robomat (EX) | 1 | Bottle volumes 20 mL to 1000 mL, 50 to 100 units per minute | – | Ettlingen |
Additional services
Quality
Production is carried out at every stage in strict accordance with GMP, with EU GMP certification for human and veterinary medicines as well as a manufacturing licence under the AMG and TAMG (RP Tübingen). In-house quality control includes routine analytics, microbiology, method development/validation and stability testing; raw materials are tested in accordance with pharmacopoeia monographs.
| Evidence | Ettlingen |
|---|---|
| EU GMP (human and veterinary medicines) | |
| Manufacturing licence under AMG/TAMG | |
| Serialisation under EU FMD | |
| ISO 9001 |
History
- 1949
Foundation of 'Pharmazeutisches Laboratorium Ettlingen' by pharmacist Prof. Dr. Wolfram Spitzner; key product Pinimenthol
- 1960er
Establishment as a leading provider in the fields of physiotherapy and professional wellness in thermal spas and upscale hotels
- 2022
Once again an owner-managed family business; owners and managing directors Andreas J. Mayer and Frank Elsen