AdhexPharma SAS

AdhexPharma SAS

CDMO for transdermal patches and oromucosal films

About the plant

 AdhexPharma is a full-service CDMO based in France and Germany, specialized in the development and manufacturing of transdermal and topical patches (TDS) as well as orodispersible and buccal films (ODF).

 With over 40 years of experience in drug delivery technologies, we offer end-to-end solutions, from formulation and analytical development to clinical and commercial manufacturing, packaging, licensing and regulatory support.

 Our facility produces over 100 million units annually, serving a diverse client base from emerging biotech to established pharmaceutical companies across Europe, North America, and selected international markets.

 The site includes cleanroom manufacturing areas, pilot and industrial equipment, and dedicated R&D and QC laboratories, supporting both early-stage and large-scale production.

 Our infrastructure spans more than 15,000 m² across four qualified buildings in France and Germany, and we are authorized to handle controlled substances.

 We currently support a pipeline of 15+ development projects and offer out-licensing opportunities for proprietary drug delivery platforms.

 Combining deep expertise in TDS and ODF technologies with a flexible, partnership-driven approach, AdhexPharma provides high-quality, integrated CDMO services to accelerate your drug development from idea to market.

 

 

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)

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Activity

• Topical, mucosal and transdermal, Patches, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
• DEA: Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL:
• Therapeutic areas: (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (N) Nervous system
• Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Development services, Manufacturing services, Analytical / QC services, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer

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