Exclusive Synthesis brochure

Dipharma publishes a review sharing its industrial expertise in azide chemistry and practical insights for safely managing hazardous processes from development to industrial scale.

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

Recognition Underscores Commitment to Sustainable Practices

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.

We are pleased to share our white paper “Dipharma’s Playbook on Bile Acid Derivatives: Turning Complex Scaffolds into GMP Reality”.

For more than 30 years, Dipharma has been working on cholane-based structures. Their rigid polycyclic backbone, stereochemical sensitivity, and susceptibility to isomerization create challenges that extend from synthetic chemistry to impurity control and industrial scale-up.

In this white paper, Dipharma highlights how its integrated capabilities span route design, analytical development, impurity qualification, and CGMP manufacturing for both established and emerging bile acid derivatives.
We hope this paper provides useful insight into the scientific and industrial considerations behind cholane chemistry, as well as the value that Dipharma can bring to projects involving these highly specialized structures. 

Let us help you master the complexity of cholane chemistry!

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

We are pleased to share our white paper, “Defusing the Azide Threat: Dipharma’s Blueprint for Safe and Scalable Chemistry.” This concise resource highlights how Dipharma leverages over 75 years of expertise to safely execute some of the most challenging—and strategically important—transformations in pharmaceutical synthesis.
From risk assessment to process design, containment, and regulatory compliance, our proven approach enables partners to access complex azide chemistry with total confidence. The case studies featured demonstrate our ability to translate high-risk science into robust, GMP-compliant solutions for commercial APIs and advanced intermediates.
Whether you are looking for innovative solutions to complex synthesis challenges or simply aiming to de-risk your development pipeline, partnering with Dipharma gives you access to deep R&D expertise and state-of-the-art technologies. 

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

Nitrosamines have been a major regulatory focus in recent years, and expectations continue to evolve.At Dipharma, we have proactively developed and refined a comprehensive approach to nitrosamine risk assessment and mitigation, integrating cutting-edge technology and rigorous quality control into our manufacturing processes.
Our white paper: “Extinguishing Nitrosamine Risk: How Dipharma Safeguards Your Product Quality” explores the complexities of nitrosamine impurities, from regulatory expectations to breakthrough analytical solutions such as our innovative ¹⁵N-NMR methodology.It also details Dipharma’s robust Risk Assessment Protocol and our proactive strategies to ensure compliance and product safety.By choosing Dipharma as your API manufacturing partner, you gain access to advanced expertise, state-of-the-art solutions, and a committed team dedicated to ensuring your success in an evolving regulatory landscape. 

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.