Industrial
Suanfarma

Your partner to success

The industrial division of SUANFARMA, as a specialized CDMO, offers our customers a “One Stop Shop” service to succeed in the challenge of developing, scaling and manufacturing an innovative or generic API, and the support offered in the FDF activity. Always following the highest Quality Standards and certifications from the main regulatory agencies in the globe.

We are proud to count on a Team of Professionals convinced that the Robustness of our processes and the exquisite performance of our SOP’s will drive us into the achievement of the required Quality, maintaining the Sustainability of the Business and the best Service to our Customers.

Our values ​​are present in any activity we carry out, as well as the ability to provide solutions to the difficulties we may face throughout the life cycle of the development of a molecule.

The Industrial Division of SUANFARMA offers its clients a complete Project Management so that they can interact with a single interlocutor, the project manager.

TECH TRANSFER

The Industrial Division of SUANFARMA has developed its own Tech Transfer Policy that, through a robust and rigorous system, manages to minimize risks during the transfer of knowledge from one company to another, or between different departments of the same company

Using the “Gathering Information Table” as a starting point, we develop a procedure in which the Process Flow Diagrams are built, we define the Critical Parameters, Sampling Plan and Identify the risks through a combination of HAZOP / FMEA model that ensure a risk control to increase the possibilities of success at this crucial stage of the life of a drug.

Full
scalability
demonstrated

The scalability of our technologies is proven and our regulatory experts advise our clients for the preparation of scaling strategies with the Drug Agencies of the different regulated countries.

We offer proposals, alternatives and solutions to the different cases that may arise.

APIS

Contract
Development

Know-how

  • Intellectual property evaluation.
  • Market evaluation.
  • Organic and Analytical development.
  • Quality assurance and regulatory support.

Lab Scale

  • Design and optimization of route of synthesis.
  • Analytical support.
  • Waste water and residues reduction.

Scale-Up

  • Kilo-Lab and pilot plant facilities.
  • Technology transfer expertise.
  • Industrial partners according to the needs.

Contract
Manufacturing

  • Specialized CDMO.
  • We cover the whole value chain. “One Stop Shop”.
  • GMP – EMA/FDA. OSHAS.
  • Microbial Fermentation & Chemical Synthesis.
  • More than 2,000 m3 of fermentation capacity.
  • Full scalability demonstrated.
  • Flexibility in processes & services.
  • Expansion capacity.
  • Segmented lines for cross-combination control.
  • Environmental sustainability “Trigeneration”.
  • Solvent recovery capacity.

FDF

Contract
Development

  • Formulation & manufacturing process design.
  • Spray Drying technology to increase bioavailability.
  • Analytical methods development & validation.

Contract
Manufacturing

  • Flexible batch size.
  • Manufacturing of tablets and capsules.
  • High potency capabilities.
  • Clinical and commercial batches.

Locations

Industrial
SUANFARMA

Fábrica

I + D

Oficina comercial

Almacén

Cipan

Company specialized in the development and manufacture of complex products with high added value. Throughout our history we have developed 3 complete generations of antibiotics derived from Tetracycline. FDA validated quality

Suanfarma Italia

We produce generic active pharmaceutical ingredients for the treatment of diseases that play an important role in improving the lives of thousands of patients worldwide. The best solution for those processes whose market demands high product needs.

Idifarma

We complete the value chain with the knowledge of the development and commercialization of drugs, from the API to the final pharmaceutical form. We offer a very specific knowledge and installation for high potency oral medications.