Manufacture of pharmaceuticals: suppositories, tablets, hard capsules and solutions according to EU GMP in Munich
bene-Arzneimittel GmbH
Munich · Geretsried · Olching · Lisbon (PT)New on Amplifa
About bene-Arzneimittel
bene-Arzneimittel GmbH is a medium-sized family business headquartered in Munich that has been manufacturing pharmaceuticals since 1949 and is now run by the second generation. At the production site in Munich-South (Herterichstraße), suppositories (suppositories and ovula), tablets, hard capsules, solutions, gels, granulates and sprays are manufactured – including active ingredients such as paracetamol, ibuprofen, diclofenac and the company's own semi-synthetic active ingredient sodium pentosan polysulfate (NaPPS), which is produced at the sister company bene pharmaChem in Geretsried. In 2-shift operation, the annual output is 100–150 million suppositories and 500 million tablets; batch sizes range from 5 to 600 kg. Production follows EU GMP with serialization (FMD compliance) on all lines. In addition to its own brand portfolio such as ben-u-ron, tacholiquin and Thrombocid, the company offers contract manufacturing of flexible small batches through to large-scale production, including pharmaceutical development, analytics, regulatory approval, storage and export to around 30 countries on 5 continents. Around 120 employees work at the Munich site.
- Site
- München
- Processes
- Manufacture of suppositories, Direct compression (tablets), Encapsulation (hard capsules), Blister packaging in thermoformable mono, duplex and triplex foils, Filling of suppositories into thermoformable plastic and aluminium foils, Cartoning and outer packaging, labeling, packaging in jars, Serialization (FMD compliance) on all lines, Manufacture of solutions for inhalation
- Materials
- Paracetamol, Ibuprofen, Diclofenac, Sodium pentosan polysulfate (NaPPS), Sodium pentosan polysulfate, Prednisolone, Codeine, Tyloxapol
- Certificates
- EU GMP, EN ISO 13485, EU GMP (manufacturing authorization Government of Upper Bavaria)
- Founded
- 1963
- Employees
- approx. 120
- Industries
- Pharmaceutical industry, Pharmaceutical manufacturing
- 01
Pharmaceutical development / galenical development
- 02
Regulatory approval
- 03
Purchasing and incoming goods inspection
- 04
Manufacturing
- 05
Analytics and release
- 06
Packaging and serialization
- 07
Storage and logistics
- 08
Export to around 30 countries
Locations
Munich
DEHeadquarters, production, administration, laboratory
- Part weight / size
- Suppositories 0.5–3.6 g
- Lot size
- Batch sizes 5–600 kg (suppositories), 100–500 kg (tablets)
- Materials
- Paracetamol, ibuprofen, diclofenac, NaPPS, prednisolone, hard fat
- 2 Sarong SAAS 15 filling and packaging lines for suppositories
- Fette PT 2090 direct compression tablet press
- Syntegon GKF 1400 capsule filling machine with 100 % weight checking
- IMA C80-A81 blister packaging machine
- Gas chromatograph (FID)
- UPLC systems with UV/VIS detection
- Ion chromatograph
- FTIR infrared spectrometer
- Raman spectrometer for incoming goods inspection
- TOC analyzer
- Particle measuring device with laser diffraction
- Climate chambers for stability studies (4 climate zones)
Geretsried
DETesting; site of the sister company bene pharmaChem (NaPPS production)
- Materials
- NaPPS
Olching
DEHigh-bay warehouse
- High-bay warehouse (2015)
Lisbon
PTSubsidiary bene-farmaceutica (sales)
Products and dosage forms
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacture of suppositoriesPharmaceutical manufacturing | – | – | 0.5 g – 3.6 g | Batch sizes 5 kg – Batch sizes 600 kg | Paracetamol, Ibuprofen, Diclofenac, Sodium pentosan polysulfate (NaPPS), Prednisolone, Hard fat |
| Direct compression (tablets)Pharmaceutical manufacturing | – | – | – | Batch sizes 100 kg – Batch sizes 500 kg | Paracetamol |
| Encapsulation (hard capsules)Pharmaceutical manufacturing | – | – | – | – | Paracetamol |
| Blister packaging in thermoformable mono, duplex and triplex foilsPackaging | – | – | – | – | Aluminium, PVC |
| Filling of suppositories into thermoformable plastic and aluminium foilsPackaging | – | – | – | – | Plastic, Aluminium |
| Cartoning and outer packaging, labeling, packaging in jarsPackaging | – | – | – | – | – |
| Serialization (FMD compliance) on all linesPackaging | – | – | – | – | – |
| Manufacture of solutions for inhalationPharmaceutical manufacturing | – | – | – | – | Tyloxapol |
| Manufacture of gelsPharmaceutical manufacturing | – | – | – | – | Sodium pentosan polysulfate (NaPPS) |
| Manufacture of ear spray / ear oil sprayPharmaceutical manufacturing | – | – | – | – | Isopropyl alcohol, Acetic acid, Dexpanthenol, Almond oil, Vitamin E |
| Manufacture of direct compression granulatePharmaceutical manufacturing | – | – | – | – | Paracetamol |
| Manufacture of juices (syrup)Pharmaceutical manufacturing | – | – | – | – | Paracetamol |
| Pharmaceutical analytics / quality control (disintegration time, active ingredient release,Testing | – | – | – | – | – |
| Stability management (stability studies, ICH conditions, 4 climate zones)Testing | – | – | – | – | – |
| Incoming goods inspection using Raman technologyTesting | – | – | – | – | – |
| Contract manufacturing (toll manufacturing) of flexible small batches through to large-scalePharmaceutical manufacturing | – | – | – | – | Paracetamol, Ibuprofen, Diclofenac, Sodium pentosan polysulfate (NaPPS) |
| Pharmaceutical development / galenical development (tech transfer)Engineering | – | – | – | – | Paracetamol, Sodium pentosan polysulfate (NaPPS) |
| Regulatory approval services (approval procedures EU and worldwide, life-cycle management,Engineering | – | – | – | – | – |
| Quality management according to EU GMP and EN ISO 13485Testing | – | – | – | – | – |
15 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Filling and packaging line for suppositories | Sarong SAAS 15 | 2 | – | – | Munich (Herterichstr. 1-3) |
| Direct compression tablet press | Fette PT 2090 | – | – | – | Munich (Herterichstr. 1-3) |
| Capsule filling machine | Syntegon GKF 1400 | – | – | – | Munich (Herterichstr. 1-3) |
| Blister packaging machine | IMA C80-A81 | – | – | – | Munich (Herterichstr. 1-3) |
| Gas chromatograph (FID) | – | – | – | – | Munich laboratory |
| UPLC system with UV/VIS detection | – | – | – | – | Munich laboratory |
| Ion chromatograph | – | – | – | – | Munich laboratory |
| Infrared spectrometer (FTIR) | – | – | – | – | Munich laboratory |
| TOC analyzer (total organic carbon) | – | – | – | – | Munich laboratory |
| Particle measuring device with laser diffraction | – | – | – | – | Munich laboratory |
| Digital microscope | – | – | – | – | Munich laboratory |
| Photometer | – | – | – | – | Munich laboratory |
| Climate chambers for stability studies (4 climate zones) | – | – | – | – | Munich laboratory |
| Raman spectrometer for incoming goods inspection | – | – | – | – | Munich laboratory |
| High-bay warehouse | – | 1 | – | 2015 | Olching (Gewerbering 11) |
Additional services
Reference customers
Quality
Manufacturing and testing are carried out according to the EU GMP guidelines (manufacturing authorization from the Government of Upper Bavaria) and according to EN ISO 13485. All starting materials are tested before use (among others using Raman technology); release is performed by the Qualified Person after complete review of the production and analysis documentation.
| Evidence | Munich |
|---|---|
| EU GMP (manufacturing authorization Government of Upper Bavaria) | |
| EN ISO 13485 |