Generic API

Olon is a leading international Generic API supplier. We have in place a global business model that allows us to be a competitive and cost-effective API supplier to the Generics industry. We manufacture products via chemical as well as biological synthesis, relying on extended internal technical expertise while meeting the highest standards of quality and reliability. We have carried on since time a business continuity program to diversify our sources for all our key raw materials and reinforce the risk mitigation plan. Additionally, Olon’s facility footprint is truly global, with bases in the United States, Europe, China, and India. This ultimately means that if there is a localized disruption in one area, operations can continue.

With a portfolio of 300 Generic APIs, we offer one of the most extensive track records in the industry and we manage more than 450 Drug Master Files.

Being an early adopter of the most advanced technology and processes, and handling the broadest range of analytical capabilities, we represent a partner enhancing competitiveness and time to market, Olon has diversified and backed investments across several lines and multiple facilities to be able to manage various high-containment molecules at different scales and guarantee flexibility on a significant scale.

Our pipeline of Generic APIs is reinforced in the oncology area, where we have solid expertise as one of the sector’s top companies producing high-activity active substances, with the introduction of numerous oncology APIs, particularly those with selective high activity.

Our comprehensive analytical testing services are carried out fully in house, this translates to significant time and cost savings for our clients. Our clients can also rely on of one of the widest ranges of leading-edge technologies chemistry and biotechnology expertise.

Controlled substances

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.

Our API Portofolio

With one of the broadest track records of the industry, Olon portfolio is highly differentiated and includes, among others, products produced by microbial fermentation, HPAPI, controlled substances, retinoic API. Consult our APIs portfolio
Our APIs

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.