The UQUIFA Group is your first choice in APIs and advanced intermediates as your CDMO partner. We can offer Research and Development (R&D) and cGMP compliant manufacturing on two continents (America and Europe).
Our focus on innovation, R&D, and marketing enables us to deliver effective and competitive product solutions to our global customer base.
Uquifa’s GMP and pre-GMP facilities inspected by relevant authorities, with over 700 dedicated personnel enable you to stay ahead of the curve in the dynamic chemical and pharma industry.
The Spanish R&D Laboratory is located at Sant Celoni (50 km North from Barcelona, Catalonia). Mexican R&D laboratory is located at Cuernavaca (100 km South from Mexico). Soneas Labs are located in the Hungarian capital, Budapest. More than 1000 square meters holds the Synthesis and Analytical development laboratories.
The teams work on the development and transfer of chemical processes suitable for the efficient manufacture of APIs and key intermediates. In these laboratories our chemists synthesize products from 1g to 1kg and develop processes which are scaleable, safe, and environmentally friendly. The researchers utilize state-of-the-art equipment including RC-1, LC-MS (including UPLC and Quiral), GC-MS and are experienced in DOE.
All available chemical literature and patents are considered together with in-house know-how to provide the best practical means for the synthesis of your product. Following investigative laboratory work, a sample is produced.
Project management is the key to our success.
UQUIFA Group continually optimizes laboratory development of synthesis to reduce isolation steps and improve yields. Reduction of batch production time and the elimination of toxic and dangerous reagents is our life blood at Uquifa. One of the major concerns in the chemical industry is to minimize any risk associated with chemical reactivity, especially when it may occur as a runaway reaction.
To prevent any incident relating to process safety, a hazard screening is crucial for all industrial processes, starting from the laboratory trials through to the industrial stage. UQUIFA Group combines technical resources and highly trained scientists to detect any potential risk associated to thermal hazards.
Our hazard screening thermochemistry include:
- Theoretical Studies
Theoretical data is evaluated to predict any potential run away reaction:
Reagent incompatibility, oxygen balance, calculations based on energy release.
- Differential scanning calorimetry (DSC)
DSC is widely used to determine the thermal behaviour of any reagent or reaction mixture during a synthesis process. A wide study by DSC is performed to determine any critical step on any synthetic process.
- Reaction Calorimetry
We are currently using Reaction Calorimetry not only for process optimization but also for a better screening of the thermal behavior of any synthesis process.
UQUIFA Group has pilot plants at all three facilities in Spain, Mexico, and Hungary. These plants are located on our cGMP sites and the pilot plants have been inspected and approved by the regulatory authorities for small-scale API/NCE production. Dedicated qualified technicians run the plants under cGMP guidelines and using identical quality control systems to those used for commercial production.
The three Pilot Plants produce 1 kg to multi-kg quantities for preclinical and clinical trials and for small scale commercial production.
Production units are designed to be flexible allowing many combinations of reactors, filters, and dryers to be used to perform the same type of reactions that are conducted at industrial scale, reactions such as nitrations, hydrogenations, we also undertake gaseous reagents such as isobutylene and chlorine gas.
Large commercial scale batches are produced at UQUIFA’s main manufacturing plants after validation runs have been completed. Regardless of the age of a process, a multi-discipline team regularly meets to discuss continued cost reduction and quality improvement.
UQUIFA’s manufacturing sites operate under cGMP conditions and have been successfully inspected by the FDA, other national agencies and by major pharmaceutical companies. Safety and environmental compliance are our highest priority, and the sites have ISO 14001 certification as well cGMP certificates.
Our Project Management System and our Regulatory Team supports the project through scale up and onto mainstream manufacture.
In addition to the regular production programs, Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation, and analytical method validation, working standard supply or impurity characterisation.
- Process transfer.
- Process development and improvement.
- Analytical methods development.
- Scale up to commercial.
- Reference standards synthesis.
- Impurity profile characterisation.
- Stability Studies.
- Polymorphism Studies.
- Regulatory support and file submission and maintenance.
Carrer Mallorca 262, 3º
Phone: +34 934 674 810