Tiefenbacher Group
Family-owned healthcare company (since 1963) providing end-to-end pharmaceutical services including API distribution, formulation R&D, GMP manufacturing (including highly potent drugs), regulatory dossier preparation and global market-entry support, plus connected dosing device co-development and digital health integration. Operations span Europe and India with integrated supply-chain, QA/RA and analytical capabilities.
Industries
Nr. of Employees
large (251-1000)
Tiefenbacher Group
Products
Finished dosage forms portfolio
Commercial portfolio and manufacturing capability for tablets, capsules, powders, liquids, inhalers, eye drops and transdermal patches across multiple therapeutic areas.
APIs and excipients portfolio
Distribution portfolio of human and veterinary APIs and excipients with supplier qualification and regulatory documentation where applicable.
Connected dosing device and companion digital service (in development)
A connected handheld dosing device and companion digital service intended to enable individualized dosing, treatment monitoring and data-driven dosing adjustments (development stage; regulatory approvals pending).
High-potent drug formulations
Advanced specialized portfolio of highly potent oncology medicines and specialized drug formulations manufactured at the Hyderabad facility in India.
OYSTA
An innovative healthcare brand launched by Tiefenbacher Group and Ondosis that revolutionizes medication intake with precise, comfortable, and intuitive dosing through a connected handheld device and digital follow-up.
Tablets, capsules, and powder suspensions for reconstitution
Bulk production, primary and secondary packaging operations of non-sterile oral solid dosage forms at Tiefenbacher's manufacturing facilities on Cyprus.
Finished dosage forms portfolio
Commercial portfolio and manufacturing capability for tablets, capsules, powders, liquids, inhalers, eye drops and transdermal patches across multiple therapeutic areas.
APIs and excipients portfolio
Distribution portfolio of human and veterinary APIs and excipients with supplier qualification and regulatory documentation where applicable.
Connected dosing device and companion digital service (in development)
A connected handheld dosing device and companion digital service intended to enable individualized dosing, treatment monitoring and data-driven dosing adjustments (development stage; regulatory approvals pending).
High-potent drug formulations
Advanced specialized portfolio of highly potent oncology medicines and specialized drug formulations manufactured at the Hyderabad facility in India.
OYSTA
An innovative healthcare brand launched by Tiefenbacher Group and Ondosis that revolutionizes medication intake with precise, comfortable, and intuitive dosing through a connected handheld device and digital follow-up.
Tablets, capsules, and powder suspensions for reconstitution
Bulk production, primary and secondary packaging operations of non-sterile oral solid dosage forms at Tiefenbacher's manufacturing facilities on Cyprus.
Services
Sourcing, supplier qualification, GDP logistics, temperature-controlled warehousing and supplier auditing for APIs and excipients across therapeutic areas.
End-to-end formulation development, analytical method development, IVIVC modelling and ICH stability studies for multiple dosage forms, with capability to develop pelletized formulations for individualized dosing.
GMP commercial manufacturing and primary/secondary packaging services from small batches to high volumes, with EU and India sites and capabilities for regulatory-compliant batch release.
Regulatory strategy, dossier preparation (e.g., ANDA/DCP/national filings), IP guidance, and coordination with marketing partners, plus lifecycle regulatory support including vigilance and post-market activities.
Engineering, regulatory and project management for drug-device combination products and companion digital services, including connected dosing device co-development, data integration for outcome-linked dosing, and device lifecycle management aligned to ISO 13485.
Sourcing, supplier qualification, GDP logistics, temperature-controlled warehousing and supplier auditing for APIs and excipients across therapeutic areas.
End-to-end formulation development, analytical method development, IVIVC modelling and ICH stability studies for multiple dosage forms, with capability to develop pelletized formulations for individualized dosing.
GMP commercial manufacturing and primary/secondary packaging services from small batches to high volumes, with EU and India sites and capabilities for regulatory-compliant batch release.
Regulatory strategy, dossier preparation (e.g., ANDA/DCP/national filings), IP guidance, and coordination with marketing partners, plus lifecycle regulatory support including vigilance and post-market activities.
Engineering, regulatory and project management for drug-device combination products and companion digital services, including connected dosing device co-development, data integration for outcome-linked dosing, and device lifecycle management aligned to ISO 13485.
Expertise Areas
- API distribution and GDP logistics
- Finished dosage form formulation and development
- Pellet-based oral formulations for individualized dosing
- Highly potent compound development and containment
Key Technologies
- GMP manufacturing
- GLP/ICH stability testing
- High-potency containment systems (OEB/OEL controls)
- Dry, wet, top-spray and hot-melt granulation
News & Updates
Announcement of an expanded collaboration to co-develop multiple projects targeting ADHD, rare diseases and transplantation medicine, including connected dosing devices, pellet-based dispensing concepts and algorithm-based dosing with planned product launches from 2023 onward.
Announcement of FDA approval of an Abbreviated New Drug Application (ANDA) for posaconazole delayed-release tablets and planned US launch with a distribution partner.
Global launch of a generic rivaroxaban formulation with multiple bioequivalence studies completed and manufacturing split between sites for early and European markets.
Announcement of distribution of an API manufactured with a biocatalytical green-chemistry process that reduces carbon footprint and hazardous solvent use.
Co-development agreement to combine traditional medicines with digital therapeutics and individualized dosing concepts (earlier collaboration announcement).
Announcement of the launch of the company's first generic version of bilastine (20 mg tablets) in Spain and planned further international launches.
Announcement of an expanded collaboration to co-develop multiple projects targeting ADHD, rare diseases and transplantation medicine, including connected dosing devices, pellet-based dispensing concepts and algorithm-based dosing with planned product launches from 2023 onward.
Announcement of FDA approval of an Abbreviated New Drug Application (ANDA) for posaconazole delayed-release tablets and planned US launch with a distribution partner.
Global launch of a generic rivaroxaban formulation with multiple bioequivalence studies completed and manufacturing split between sites for early and European markets.
Announcement of distribution of an API manufactured with a biocatalytical green-chemistry process that reduces carbon footprint and hazardous solvent use.
Co-development agreement to combine traditional medicines with digital therapeutics and individualized dosing concepts (earlier collaboration announcement).
Announcement of the launch of the company's first generic version of bilastine (20 mg tablets) in Spain and planned further international launches.