GMP-certified chemical distributor: pharmaceutical starting materials, cleanroom filling and laboratory analytics.
Aug. Hedinger GmbH & Co. KG
Stuttgart · TeutschenthalNew on Amplifa
About Aug. Hedinger
Aug. Hedinger GmbH & Co. KG is a chemical trading and pharmaceutical company founded in Stuttgart in 1843 with around 160 employees and revenue of over 100 million euros. From its headquarters in Stuttgart and the Teutschenthal branch, the company supplies almost all sectors of the processing industry with chemical raw materials and pharmaceutical starting materials, organised into four areas of expertise: Pharma, Life Science (Food and Personal Care), Pharmacies and Chemical-Technical Industry. Services include cleanroom filling (Class 100,000 or Class D), production of aqueous solutions such as isopropyl alcohol 70% or sodium hypochlorite solutions according to GMP, repackaging of bulk goods up to 1000 kg IBCs, production of non-sterile liquid medicines for external use, and Customized Aqueous Solutions based on highly purified water according to Ph. Eur. Both sites have EU-GMP-certified laboratories with analytical equipment (GC, HPLC, FT-IR, UV-Vis, AAS, TOC, KF) in which every batch is tested. The supply chain is fully traceable back to the producer, and four Qualified Persons under § 14 AMG perform final release of the products.
- Site
- Stuttgart
- Processes
- Filling/packaging of chemicals and active ingredients in cleanrooms (Class 100,000 / Class D), Transferring bulk goods from tank trucks and storage in storage tanks, Repackaging of Tetraethylene Glycol in 1000 kg IBCs or 230 kg drums, Filling/Repackaging (cleanrooms Class 100,000 or Class D), Customized aqueous solutions (Highly Purified Water EP / Water for Injection USP), Batch traceability back to the producer, Regulatory support (REACH, biocide registrations), Hazardous substance advice and delivery information
- Materials
- Isopropyl Alcohol GMP (IPA), Isopropyl Alcohol 70% (V/V) Biocide, Acetone, Glycerol 99.7% (synthetic), Glycerol 85%, Propylene Glycol, Acetic Acid 99% (Glacial Acetic Acid), Acetic Acid 80% API Grade
- Certificates
- ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, EU-GMP Part I (Medicinal Products), EU-GMP Part II (Active Substances), EU-GMP (Excipients), EXCiPACT (GMP/GDP), EXCiPACT (GMP/GDP, Teutschenthal site), SQAS/ESAD, Responsible Care, ISO 9001, ISO 14001, ISO 45001, EU-GMP Part I, EU-GMP Part II, EXCiPACT
- Founded
- 1843
- Industries
- Pharmaceutical Industry, Life Science (Food, Personal Care), Pharmacies, Chemical-Technical Industry, Teaching Materials/Education
- 01
Procurement from defined world-market producers
- 02
Transport in pre-loaded/product-specific tank trucks
- 03
Transferring bulk goods into storage tanks
- 04
Production of aqueous solutions or cleanroom filling via mono lines
- 05
Analytical testing and release in the in-house laboratory
- 06
Packaging and batch traceability
- 07
Distribution via pharmaceutical wholesalers or directly to industry
Products & Processes
Isopropyl Alcohol GMP Ph. Eur./USP/JP
Active ingredient for pharmaceuticals and cleanroom filling, also 70% (V/V) as an EU-approved biocide.
Acetic Acid 99% Ph. Eur./USP/JP (Glacial Acetic Acid)
Ultra-pure quality ≥ 99.9% for Food, Pharma and API-Grade solutions, filling in the cleanroom.
Glycerol 99.7% Ph. Eur./USP (synthetic)
Synthetic, ultra-pure glycerin for pharmaceuticals, Food and Parenteralia.
Propylene Glycol Ph. Eur./USP
Solvent and carrier for formulations in pharmaceuticals, cosmetics and food.
Sodium Hypochlorite Solution 1% and 3% DAC
Produced under GMP in Class D cleanroom, for root canal treatment.
Hydrogen Peroxide Solution 30% Ph. Eur. / 3%
Disinfectant for pharmacies and wound disinfection with standard marketing authorisation.
Tetraethylene Glycol (TTEG)
Technical glycol with repackaging in 1000 kg IBCs or 230 kg drums.
BHT (Butylated Hydroxytoluene) GMP Ph. Eur./USP/JPE
Antioxidant for cosmetic and pharmaceutical formulations.
Purified Water Ph. Eur. (Aqua purificata)
Production via reverse osmosis, electrodeionisation, ultrafiltration and UV irradiation.
Locations
Stuttgart
DEHeadquarters/main site: production, laboratory, distribution
- Materials
- Isopropyl alcohol, acetone, wound benzine, pharmaceutical starting materials
- EU-GMP-certified laboratory (GC, HPLC, FT-IR, UV-Vis, AAS, TOC, KF)
- Manufacturing authorisation under § 13 AMG
Teutschenthal
DEBranch in Saxony-Anhalt: production, cleanroom filling, laboratory
- Part weight / size
- up to 1000 kg IBC / 230 kg drum
- Materials
- Acetic acid, glycerol, propylene glycol, isopropyl alcohol 70%, sodium hypochlorite
- Class 100,000 / Class D cleanrooms with mono lines
- Storage tanks for bulk goods
- EU-GMP-certified laboratory
- Manufacturing authorisation under § 13 AMG
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Filling/packaging of chemicals and active ingredients in cleanrooms (Class 100,000 / Class D)Assembly | – | – | – | – | Acetic acid, Glycerol, Isopropyl alcohol, Isopropyl alcohol 70% (V/V), Propylene glycol, Acetone, Sodium hypochlorite solution, Hydrogen peroxide solution, Purified water |
| Engineering | – | – | – | – | Acetic acid 80%, Isopropyl alcohol, Sodium hypochlorite, Hydrogen peroxide, Purified water |
| Transferring bulk goods from tank trucks and storage in storage tanksAssembly | – | – | – | – | Acetic Acid Ph. Eur./USP/JP |
| Assembly | – | – | – | – | Acetic acid, Isopropyl alcohol 70% (V/V), Glycerol |
| Surface | – | – | – | – | Purified Water Ph. Eur. (Aqua purificata) |
| Testing | – | – | – | – | Starting materials and chemicals (active ingredients and |
| Assembly | – | – | – | – | Glycerol Ph. Eur./USP/ChP (synthetic), Propylene glycol, Isopropyl alcohol, Acetone, Butylated hydroxytoluene, Acetic Acid Glacial |
| Repackaging of Tetraethylene Glycol in 1000 kg IBCs or 230 kg drumsAssembly | – | – | 230 kg – 1000 kg | – | Tetraethylene Glycol (TTEG) |
3 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Laboratory analysis equipment (GC, HPLC, FT-IR, UV-Vis, AAS, TOC, KF, IR spectroscopy) | – | – | – | – | Stuttgart, Teutschenthal |
| Cleanrooms (Class 100,000 / Class D) with mono lines for filling/packaging | – | – | – | – | Teutschenthal |
| Storage tanks for bulk goods | – | – | – | – | Teutschenthal |
Additional services
Reference customers
Quality & Certifications
Two EU-GMP-certified laboratories in Stuttgart and Teutschenthal test every batch with GC, HPLC, FT-IR, UV-Vis, AAS, TOC and KF; four Qualified Persons under § 14 AMG perform final release of products. Batches are traceable online back to the producer.
| Evidence | Stuttgart | Teutschenthal |
|---|---|---|
| ISO 9001 | ||
| ISO 14001 | ||
| ISO 45001 | ||
| EU-GMP Part I | ||
| EU-GMP Part II | ||
| EXCiPACT | ||
| SQAS/ESAD |
History
- 1843
Founding of the headquarters in Stuttgart
- 1948
Conversion into a limited partnership (HRA 1583, Stuttgart)
- 1967
Conversion into a GmbH & Co. KG, general partner AH-Beteiligungsgesellschaft mbH
- 1986
Founding of the Chemical-Pharmaceutical Laboratory
- 1992
Opening of the Teutschenthal branch
- 1997
First certification of the integrated quality and environmental management system by TÜV Switzerland
- 1999
First European chemical trading company with ESAD assessment