Manufacturing

ROVI has three research and development centres and five manufacturing plants for its own products and services to others. The work performed at these facilities is crucial to the Group’s business.

CDMO

ROVI provides an answer to the growing trend among pharmaceutical companies to their development and manufacturing processes.

Thus, the Company makes use of the high manufacturing capacity available at its facilities by providing the whole range of manufacturing services: oral forms and injectables.

Why we stand out

3 Plants

3 plants

We have three production plants, two of which are used for injectables, while the other specializes in solid forms

Wide range of pharmaceutical forms

Wide range of pharmaceutical forms

Our products span a wide range of pharmaceutical forms, including prefilled syringes, vials and sachets

All services within the same company

All services within the same company

We offer a unification of all services within the same company , from the development of a project until the final release of the product, including the manufacturing of pilot and industrial batches, stability studies and physical, chemical and microbiological analyses, with the resulting savings of time and money for the customers. Thus, we provide a personalized service to meet each customer’s needs.

Own product manufacturing

In addition to the three contract manufacturing plants, we have two plants
manufacture our own products in Granada, where we produce Bemiparin and Enoxaparin

Injectables

We are one of the leading prefilled syringe manufacturers in Europe in terms of the number of units manufactured (filled) per year.

ROVI CONTRACT MANUFACTURING
Madrid

R+D+i

Annual production capacity:

150
MILLION
Syringes
150
MILLION
Suppositories

The plant is approved by the European and United States regulators. It has also been approved by the regulators of Korea and Brazil and the Gulf States. It likewise holds the ISO 9001, ISO 14001 and OSHAS certifications.

INJECTABLES PLANT
San Sebastián de los Reyes

Annual production capacity:

120
MILLION
Syringes
60
MILLION
Vials

Approved by the European regulator.

Solid Oral Forms

We have a dual guarantee: tradition in the manufacture of pharmaceutical products and the most advanced technology for the manufacture of solid oral forms. This combination allows us to offer other companies a service that is supported by the figures.

FROSST IBERICA
Alcalá de Henares

Annual production capacity:

3.000
MILLION
Tablets
300
MILLION
Hard Capsules
30
MILLION
Sachets

Storage capacity:

9.000
Pallets

Approved by the European and United States authorities and the regulators of Japan, Mexico, Brazil, Kenya, Belarus and the Gulf States.

Bemiparin®

In addition to the three contract manufacturing plants, we have a plant to manufacture our own products in Granada, where we produce Bemiparin and Enoxaparin, the active substances of our main proprietary research products.

Planta de fabricación  propia de Bemiparina. Granada

OUR BEMIPARIN
MANUFACTURING PLANT.

Granada

I+D+i

Annual production capacity:

500.000
MILLION UNITS OF
Low-Molecular-Weight

Ensayos Clínicos

Al trabajar tanto bajo los estándares de calidad americanos como europeos, ofrecemos un soporte técnico competitivo desde el punto de vista de costes, flexible y fiable.

Ofrecemos una amplia gama de servicios para la ejecución de ensayos clínicos, elaboración y envasado, etiquetado, empaquetado y logística, siempre bajo los estándares más estrictos de calidad.

La maquinaria utilizada es la misma que la utilizada en un lote a tamaño industrial, por lo que se cumple con la última normativa europea referente a ensayos clínicos.

Ensayos Clínicos

Water for Injection (WFI)

Water for injection

Injectable plant offers our customers pre-filled syringes with water for injections (WFI - Water for Injections) in different sizes and volumes, produced according to the requirements of the European and American Pharmacopoeias.

 

The CTD (Common Technical Dossier) and DMF (Drug Master File) modules are offered free of charge to facilitate the registration process.

 

Shelf life: 3 years

Syringe and volumes:

  • 1.25 ml filled from 0.5 to 1 ml. Bracketing strategy (all sizes from 0.5 to 1 ml)
  • 3 ml filled to 2.18 ml
  • 10 ml filled from 5 to 10 ml. Bracketing strategy (all sizes from 5 to 10 ml)
  • 20 ml filled to 15 and 20 ml

VIEW WFI ROVI PLANTS