Custom Development and Manufacturing
Through chemical synthesis, microbial biomanufacturing or a semi-synthesis approach, we offer, under GMP, dedicated solutions for the development and manufacturing of NCEs, advanced Intermediates, building blocks, enzymes & proteins, peptides of rDNA origin and high potency drugs.
We guarantee customer support from the R&D lab up to full-scale commercial manufacturing and dossier submission. Our experience and global footprint allow us to follow the entire process in house, with a single point of contact for the customer and complete accountability, and to submit IP documentation in every country in the world, thanks to direct access to local regulatory authorities.
During product development and technology transfer, our partners are supported by a dedicated team. The team is made up of two units: a project manager unit, which plans and tracks all activities, resolves any conflict of resources, solves critical issues, and communicates news and updates, and a technical unit, which provides regular updates on the project status (Reports – TCs), communicates directly with the customer for technical topics, and supports the regulatory strategy.
- 23 Active Projects on Late Intermediates for New Chemical Entities;
- 12 Active Projects to Final API as New Chemical Entities.
Olon is a global leader in active pharmaceutical ingredients. We manufacture these products by using complex chemistry and technical expertise while maintaining a long-standing reputation of quality and reliability. We work with generic drug companies well in advance of drug patent expiration, providing non-infringing processes and filing Drug Master Files (DMF) or Certificates of European Pharmacopoeia (CEP) for the APIs.
We work with generic drug companies well in advance of drug patent expiration, using high quality, non-patent infringing processes to manufacture APIs.
Our track record marks 295 APIs in total, and in the last 5 years 26 Active Projects to final API supporting New Filing.
Dossier - Active Pharmaceutical Ingredients List
We are expanding our business in the generic market also through Finish Dosage Forms (FDFs), taking advantage of our strong position in API development and manufacturing. We can count both on FDFs already available for licensing and on FDFs with co-development opportunities.
In this process, you will not be just a customer, but a partner fully involved in the project definition and decisions, through constant, proactive and transparent communication, as we are both engaged to achieve the same result: successfully complete the FDF development, dossier registration and commercialization.
First-class analytical chemistry, synthetic chemistry, engineering, and API manufacturing services designed to meet customers’ needs throughout all phases of drug and chemical development, from preclinical to post-marketing.
Collaboration between chemists and engineers allows us to combine established and novel practices for efficient, successful manufacture of your product, ensuring a safe, fast, and economical commercial manufacturing process.
We are constantly inspected by the regulatory bodies of all the Countries where we market our products.
We offer integrated services, including Dossiers. We are expanding our business in the generic market also through Finish Dosage Forms (FDFs), taking advantage of our strong position in API development and manufacturing. We can count both on FDFs already available for licensing and on FDFs with co-development opportunities.
On few selected strategic projects, we are ready to provide Finish Dosage Forms by its wide and reliable network of CDMOs.
In addition to supplying APIs, we offer in-licensing opportunities of available products and generic product development partnerships as part of our service to customers.
Cutting-Edge Technology & Hazardous Chemistry
Our cutting-edge technologies include:
- cryogenic technology (down to -80 °C)
- high potent compound handling capabilities
- photochemical conversions
- chromatographic purification
- high pressure hydrogenations
- biocatalytic transformation
- flow chemistry
- Spry drying
- Cyanation (hundreds of kgs of cyanide/batch)
- Bromination (up to 1,500 kg/batch)
- Fluorination with either Electrophilic or Nucleophilic fluorinating agent (No F2)
- Large-scale oxidations even in organic solvents
- Hydride Chemistry (up to hundreds of kg active)
- Organometallic reagent such as Lithium Reagents (up to hundreds of kg active)
- Reaction with Sodium metal (up to 150 kg per production batch)
We are a global provider of high-quality services in the field of custom microbial process development and manufacturing, with a total fermentation capacity of 4,500 m³, based on 65 fermenters, spread between two manufacturing locations in Italy. We also have a manufacturing site in India with a fermentation capacity of 400 m³. We offer dedicated solutions for peptides, proteins, enzymes and small specialty molecules, focused on applications in pharmaceutical, food and bio-industrial sectors for customers in Europe and the United States.Microbial fermentation is an eco-friendly and highly sustainable process that mostly utilizes just water, natural nutrients and microorganisms. It reduces the use of chemical solvents that are needed, just for few cases, in the purification phase. In all the biotechnology centers the use of chemical solvents is very limited.
Relying on over 50 years of experience, Olon is one of the few companies still producing via microbial fermentation in Italy and Europe. Our biotechnology centers produce APIs for life-saving therapies, such as antibiotics and oncology drugs.
Our expertise is based on working with a variety of microbes, ranging from yeast (Saccharomyces, P. Pastoris) to bacteria (E. coli, Bacillus, Streptomyces) to fungi (Aspergillus, Trichoderma).
We rely on technological platforms, such as spry dryers. Our flexibility is also reflected in the isolation and purification phases because we can rely on 20 different downstream plants. Furthermore, the Olon Biotechnology Center can count on great in-house engineering expertise.
We are licensed to import narcotic raw materials on a commercial scale and routinely manufacture and distribute controlled substances such as psychotropics and intermediate lysergic acid throughout the world.
Our sites have been licensed to manufacture controlled substances for many decades. During the manufacture of controlled substances, we follow a number of security and laboratory controls in addition to highly regulated training and safety protocols to ensure the safe handling of controlled substance APIs. Law enforcement is regularly present in our sites to monitor manufacturing and to verify that operations are properly documented in the relevant dedicated registers.
Schedule III and IV APIs are currently licensed: Diethylpropion HCl, Phendimetrazine Tartrate, Phentermine HCl, Benzphetamine HCl.