Development and Manufacturing of New APIs: Leveraging Experience, Technological Innovation, and Present Vision to Future Success.

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.

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

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 Company continues to strengthen its capabilities in the North American market

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.

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

Dipharma develops proprietary chemical processes and alternative solutions to support the generic API industry.Our customers can rely on a true turnkey service, where commercially competitive products are promptly conceived and manufactured in full compliance with third-party intellectual property rights.
Along with quality, confidentiality, safety and meeting deadlines, we ensure a well-established and reliable supply chain for your peace of mind. 
Our current product portfolio comprises over 40 high quality APIs.

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

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.

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

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

Kalexsyn Inc. announced that its Board of Directors appointed Brian Eklov to succeed Robert Gadwood, who is retiring, as Chief Executive Officer and Board member.

The new plant brings significant positive impact on the environment and sustainable development

Received 468 White Certificates

Italy’s Dipharma Francis has completed construction of a new cGMP manufacturing suite at its US subsidiary, Kalexsyn, strengthening its service offering and ensuring continuity across the product lifecycle from preclinical to commercialisation , the contract research and development organization announced Monday.