CDMO for the development and manufacture of transdermal patches and oral films – from idea to market.
AdhexPharma, SAS
Paris · Chenôve · Langenfeld · HamburgNew on Amplifa
About AdhexPharma
AdhexPharma is an independent pharmaceutical company (CDMO) specializing in the development and manufacture of patches (topical and transdermal) as well as oral films (fast dissolving, buccal, sublingual). The company covers the entire value chain: formulation development, feasibility, analytical method development, scale-up, validation batches and commercial manufacturing with a capacity of around 180 million units per year. Processes include weighing and blending (5 to 300 kg), coating and drying on five production lines, slitting, converting as well as primary and secondary packaging. Active ingredients and excipients processed include hormones, highly potent APIs, narcotics and peptide analogues. Customers come from the pharmaceutical industry and biotechnology, including AcuCort (Zeqmelit®). The sites include headquarters in Paris, R&D and production in Chenôve (France) as well as Labtec sites for R&D in Langenfeld and production in Hamburg. Manufacturing is performed in compliance with cGMP according to EMA and FDA standards; the company is ISO 13485 certified.
- Site
- Chenôve
- Processes
- Oral films manufacturing (fast dissolving, buccal, sublingual), Patch manufacturing (topical/transdermal), Mixing (APIs and excipients), Coating & drying (film coating), Slitting (cutting of jumbo rolls), Converting & primary packaging, Secondary packaging, Weighing & blending
- Materials
- API (active ingredients), Excipients, Hormones, Highly potent APIs, Narcotics, Peptide analogues, Active ingredients (API)
- Certificates
- ISO 13485, EU GMP (ANSM/BfArM), US cGMP (FDA)
- Industries
- Pharmaceutical industry, Biotechnology
- 01
Contract Development (feasibility, formulation development)
- 02
Weighing & blending
- 03
Coating & drying
- 04
Slitting
- 05
Converting & primary packaging
- 06
Secondary packaging
- 07
Analytical testing and release
- 08
Warehousing and market launch
Active Ingredients & Processing Forms
Active ingredients (API)
Processing of active ingredients including hormones, highly potent APIs and narcotics in patches and oral films.
Excipients
Selection and sourcing of suitable excipients during development.
Hormones
Processing of hormonal active ingredients, historically documented by the first hormonal patch.
Highly potent APIs
Handling of highly potent active ingredients under cGMP-compliant conditions.
Narcotics
Storage and testing of narcotics including stability-compliant storage.
Peptide analogues
Development of an oral film for administration of peptide analogues via the cheek (BUCCAL-PEP).
Sites
Paris
FRHeadquarters
Chenôve
FRR&D and production
- Lot size
- Laboratory scale to commercial manufacturing
- Materials
- APIs, excipients, hormones, highly potent APIs, narcotics
- 5 production lines (coating)
- Mixing vessels 5–300 kg
- Slitting machines
- Packaging lines (primary/secondary packaging)
- 2000 m² pharmaceutical warehouse
Langenfeld
DELabtec R&D
Hamburg
DELabtec production
Dosage Forms
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Oral films manufacturing (fast dissolving, buccal, sublingual)Plastics | – | – | – | Pilot scale – commercial manufacturing, 180 million | API, Excipients |
| Patch manufacturing (topical/transdermal)Plastics | – | – | – | – | API, Excipients |
| Mixing (APIs and excipients)Plastics | – | – | 5 kg – 300 kg | – | API, Excipients |
| Coating & drying (film coating)Plastics | – | – | – | – | API, Excipients |
| Slitting (cutting of jumbo rolls)Plastics | – | – | – | – | Films/patch materials |
| Converting & primary packagingAssembly | – | – | – | – | Patches, Films |
| Secondary packagingAssembly | – | – | – | – | Pouches |
| Weighing & blendingPlastics | – | – | – | – | API, Excipients |
| Contract Development (formulation development, feasibility, scale-up)Engineering | – | – | – | Laboratory scale – Validation batches | API, Excipients |
| Clinical trial supply manufacturingPlastics | – | – | – | – | API, Excipients |
| Formulation transferEngineering | – | – | – | – | API, Excipients |
| Analytical method development and validation (assay/purity, drug release, residual solvents,Testing | – | – | – | – | Pharmaceuticals |
| Stability storage and stability testing (ICH Q1A, stress testing)Testing | – | – | – | – | Pharmaceuticals |
| Planar dosage forms analytics (in-vitro skin/mucosa permeation, tensile testing)Testing | – | – | – | – | Patches, Oral films |
| Licensing (market-ready products)Engineering | – | – | – | – | – |
5 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Mixing vessels/tanks | – | – | 5 to 300 kg | – | Chenôve |
| Production lines (coating) | – | 5 | – | – | Chenôve |
| Packaging lines (primary and secondary packaging) | – | – | multiple formats, small to large series | – | Chenôve |
| Slitting machines | – | – | – | – | Chenôve |
| Pharmaceutical warehouse | – | – | 2000 m² | – | Chenôve |
Additional services
Reference customers
Quality & Certifications
Manufacturing is performed in compliance with cGMP according to EMA and FDA standards (including EU GMP ANSM/BfArM, 21 CFR 210, 211, 820, Part 11). Batch release is performed by a Qualified Person (QP).
| Evidence | Chenôve | Hamburg |
|---|---|---|
| ISO 13485 | ||
| EU GMP (ANSM/BfArM) | ||
| US cGMP (FDA) |
History
- 1980er
Foundation of an R&D unit by Fournier Laboratories
- 1990er
Market launch of a hormonal patch, export and marketing in the USA
- 2000er
Foundation of AdhexPharma, takeover of the Fournier Laboratories patch R&D and production unit
- 2010er
3 new productions, 4 marketing authorizations, ISO 13485 certification
- 2020er
Acquisition of AMW's transdermal assets and acquisition of Labtec (formerly tesa Labtec); ISO 13485 since September 2020