Concept

The human health sector and the segment of specialty pharmaceuticals products in particular, is a business field with remarkable prospects. Rontis has made the strategic decision to enter the pharmaceutical sector through an exceptional investment (25m€) for the construction of a brand new pharmaceutical manufacturing plant in Greece, combined with additional investment in establishing a separate in-house R&D lab focused on the developments of specialty pharmaceutical products.

The pharmaceutical plant of Rontis is located in a 9.200 square meters area in the Industrial Zone of Larissa, Central Greece and began operations in mid-2012, marking a new business activity era for Rontis.

This new sophisticated business unit was constructed based on the most advanced expertise and equipped with state-of-the-art machinery, ensuring optimum production conditions for our clients.

Our manufacturing plant is highly specialized in producing a great range of solid dose formulation forms and it has already been EU-GMP approved from the Local Health Authorities and successfully audited by multiple European customers.

Our platform of operation is customer oriented and our target is to provide the full range of services and production capabilities of our plant to our customers in order to become the trusted partner of choice. Rontis bears proof of our vision and aspirations of becoming a leading developer and manufacturer of specialty pharmaceutical products.

R&D

Rontis has made significant investments in the field of  Pharmaceutical Research and
Development , including the recruitment of highly skilled and experienced scientists and the establishment of state-of-the-art R&D lab, that allows Rontis to plan its developments and research proactively, in order to respond timely to the needs of its target markets.

Rontis R&D lab, set-up in 2014, offers research support to Rontis’ activities, operating in collaboration with international Research centers for the development of specialty pharmaceutical products, generic medicines, new formulations and innovative solutions.

Our target is to develop new patient-compliant forms of specialty pharmaceutical products with advance therapeutic efficiency.

In addition, we invest in the development of dosage units which contain combination of drugs and in the research of new drug release forms.

Quality

Rontis has a Quality Management System meeting the European Good Manufacturing Practice (EU-GMP), which are a series of general principles that must be observed during manufacturing. Rontis has determined effective and efficient quality processes to comply fully with the EU-GMP.Our Quality system has been successfully audited by the Local Health Authorities and multiple European customers, while internal processes review and revise our practices periodically in order to ensure meeting highest standards and our partner’s expectations.

Our staff is being continuously trained in order to be up-to-date with the latest GMP standards and guidelines.We are committed to be proactive & responsible by providing tailor made solutions and services to our customer needs, ensuring constant compliance with the highest quality parameters set.Responsibility and integrity are the key features that characterize our company at each and every stage of our research & development, our performance of studies, our method validation and the stability programs we constantly run.

Products

Specialty pharmaceutical products  follow the core of Rontis’ commitment that underlines our “Driven by innovation” philosophy, as our products offer affordable therapeutic choices with safe and efficient results.

Our activity focuses on the development of specialty pharmaceutical products and the formulation of new dosage or new forms of medicine in all therapeutic categories, the manufacturing of these products in our state of the art pharmaceutical plant and the marketing of these medicines through our wide international network of operations and business partners.

Within this framework we have the ability to develop dossiers for out-licensing of our own specialty pharmaceutical products and formulations. Our goal is to expand our clientele and product portfolio through strategic partnerships. Our starting point is the expertise gained through our own developments and our expert personnel specializing in all individual services such as formulation and regulatory authorization.

For additional information concerning our Pharmaceuticals portfolio please visit our dedicated website www.rontispharmaceuticals.com

Contract Manufacturing Services

Contract manufacturing is our core business area of expertise. We are able to manufacture and provide a wide range of solid products to third parties. We have already established an internal platform of operations that has led us to create partnerships with well-known clients such as pharmaceutical companies and R&D houses.

Pharmaceutical production is a highly complex process requiring investment in infrastructure and qualified personnel, and above all commitment and dedication in ensuring compliance with the very demanding requirements and rapid developments of the global pharma sector.

In our manufacturing plant, we can produce pharmaceutical products in the following solid dose formulation forms with an exceptional annual capacity through a wide range of manufacturing processes as well as the corresponding individualized packaging:

 

Solid formulation forms

rontis-bulletTablets uncoated

rontis-bulletSlow release tablets

rontis-bulletTablets film or spray sugar coated

rontis-bulletHard gelatin capsules, containing granule powder or pellets (all sizes)

rontis-bulletPowders

rontis-bulletGranules

rontis-bulletPellets

 

Manufacturing processes

rontis-bulletWet granulation

rontis-bulletSpray granulation

rontis-bulletFluid bed drying

rontis-bulletDry mixing

rontis-bulletExtruder/ Spheronizer

rontis-bulletOrganic solvents handling

 

Packaging

rontis-bulletPrimary and secondary packaging

rontis-bulletPackaging in Blister Alu-Alu, Alu-PVC, Alu-PVDC, Alu-Peel off, PP,ACLAR, Triplex, perforated, unperforated

rontis-bulletPackaging in sachets

rontis-bulletPackaging in various folding box designs

rontis-bulletSupport in formulation and packaging development

rontis-bulletCoordination/packaging of initial supply quantities following marketing authorization

 

Annual Production Capacity

rontis-bullet3.000.000.000 tablets

rontis-bullet260.000.000 capsules

rontis-bulletPackaging : 100.000.000 blisters

 

Analytical Development

rontis-bulletAssay method development & validation

rontis-bulletDissolution profiling

rontis-bulletDegradation studies

 

Process Optimization

rontis-bulletScale up and Validation of analytical methods of finished products

rontis-bulletProduction of pilot and industrial batches for product transfers and industrialization

 

Stability Studies

rontis-bulletStability programs according to ICH and documentation according to CTD requirements.