Dipharma's Catalogue APIs

Recognition Underscores Commitment to Sustainable Practices

Learn more about Dipharma’s Catalogue API products and services. Discover how we support the generic API industry.

Dipharma Inc. has been inspected by the US FDA and has received the EIR, satisfactorily closing the inspection process. The Company expands its range of CGMP services to include small-scale commercial APIs.

Explore Dipharma’s leaflet of our Generic APIs with regulatory status across major agencies worldwide. Trusted partner for high-quality APIs.

The Company strengthens its analytical R&D capabilities, to better support its customers operating in the CDMO and Generics market.

Achieve your goals more easily, safely and rapidly. Dipharma is your optimal choice for Exclusive Synthesis services from discovery to the commercial stage.

The Company continues to strengthen its capabilities in the North American market

The Baranzate site (Italy) is the first Dipharma manufacturing facilityto receive Anvisa certification

Achieve your goals more easily, safely and rapidly.The ability to develop innovative synthetic processes, combined with proven know-how in the handling of hazardous chemicals and reactions, makes Dipharma your optimal choice for Exclusive Synthesis services from discovery to the commercial stage.We provide you with tailor-made development and manufacturing of new and complex molecules, all the required analytical and regulatory assistance, as well as support in pre-formulation activities.

Thanks to the approval by the Italian Medicines Agency (AIFA),the Company increases its efficiency and is able to face the growing demand for its services

In today’s globalized economy, international integration plays a crucial role in the development of new molecules. This integration encompasses various aspects, including the transfer of production activities and the utilization of past experiences. Risk and Innovation: The development of APIs (active pharmaceutical ingredients) utilizes innovative process techniques and potentially hazardous chemical reactions. Leveraging past experiences is essential to mitigate risks and optimize production. Solid-State Development: A deep understanding of solid-state properties is critical for API manufacturers. Solid-state characterization ensures product stability, bioavailability, and manufacturability.

EcoVadis has rated Dipharma Francis’s performance among the top 25% of all organizations surveyed.

The Dipharma Group is a global Contract Development and Manufacturing Organization (CDMO) and a leading manufacturer of Active Pharmaceutical Ingredients (APIs), New Chemical Entities (NCE), and advanced Intermediates for Generic and Contract Manufacturing markets, offering APIs with DMFs registered worldwide. 

The merger represents the last step of Kalexsyn’s integration into the Dipharma Group

The CGMP pilot plant located in our production site of Mereto (Italy) is equipped with cutting-edge technologies, providing powerful tools to supply from early drug development up to the market. The pilot plant consists of two production lines, each equipped with 2 stainless steel and 2 glass-lined reactors and can produce batches ranging from 5 to 50 kilograms. 
Our state-of-the-art equipment, combined with demonstrated expertise and flexibility, makes Dipharma the optimal choice to support your projects. 


EXPERIENCE YOU CAN TRUST.

With an investment of €2.7 Million, the company continues to consolidate its position to be among the leading small molecule CDMOs. The new production line doubles the capacity of the existing pilot plant.