Sanochemia Pharmazeutika AG - API Synthesis and Final Dosage Forms

Sanochemia Pharmazeutika is an Austrian company that acts as a service provider for API synthesis and contract manufacture of final dosage forms. Sanochemia has established a sophisticated production division for the pharmaceutical environment, including development and upscaling facilities.

Sanochemia has evolved to become a vertically integrated outsourcing partner. With the experience and technology to run API synthesis as well as manufacturing of sterile and non-sterile liquid and semisolid final dosage forms, Sanochemia’s production division offers tailored solutions to customers.

Complex chemical synthesis

Expertise in complex chemical synthesis, coupled with one of Europe’s most modern plants, has secured worldwide recognition for Sanochemia in this field. Sanochemia has established an excellent reputation for contract manufacture from gram-scale to commercial manufacturing volumes in a cGMP-compliant plant for active pharmaceutical ingredients.

Active pharmaceutical ingredients

Sanochemia tailors active pharmaceutical ingredients, and has the following facilities and capabilities:

• Process development labs for highly active ingredients (HAPI)
• Pilot plant for upscaling purposes from 10l to 100l
• 12m³ cGMP multi-purpose manufacturing plant
• Raw material procurement and material management
• Development and validation of analytical methods
• Filing of drug master files and regulatory support
• Pilot plant for high potentcy APIs for clinical trial investigations

Complex organic synthesis

We offer outstanding levels of competence in the following complex organic synthesis fields:

• Chiral synthesis and resolution
• Hydride reactions
• Heterocyclic chemistry

Final dosage forms, parenterals, and sterile and non-sterile liquids and ointments

Long years of experience in the fields of product development, formulation, analytical development and registrations have made Sanochemia a full-service provider for contract manufacturing of final dosage forms.

Our track record has been established through manufacturing for a number of major pharmaceutical companies, projects that reflect our focus on:

• Parenterals (injection and infusion solutions)
• Sterile and non-sterile liquids (oral and rectal)
• Sterile eye ointments
• Topical ointments and gels for human and veterinary medicine

Stability studies, physical chemical characterisation and analysis of APIs

Sanochemia has demonstrated that seamless GMP production and documentation and short processing times with a high degree of flexibility aren’t mutually exclusive. In order to ensure both, we have invested heavily in a state-of-the-art plant and facilities. Of course, this also entails highly skilled staff and modern IT systems. We continuously monitor progress and advance to meet forthcoming regulations upfront.

Our qualified team of chemists is on hand to offer our clients a full range of analytical services including:

• Comprehensive pharmaceutical analysis of APIs and finished products using standard chromatographic methods (HPLC, GC and IC) and standard microbiological methods (preservative challenge tests, endotoxin and sterility testing)
• Stability studies under controlled ICH conditions
• Comprehensive physical chemical characterisation of reference materials and impurities

Raw material and packaging material sourcing, manufacturing, product analysis and batch release

Our service range encompasses:

• Raw material and packaging material sourcing
• Manufacturing
• Raw material, bulk material and finished product analysis
• Packaging including administration and purchasing
• Batch release

Our full-service concept also extends to handling the logistics of your contract manufacturing orders. Let our highly experienced export department shorten the supply chain to your customers by making all the necessary export arrangements.

Sanochemia understands pharmaceutical products, from the API to the final formulation. This combined know-how gives us a better understanding of the demands of our pharmaceutical business partners.