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
We have three production plants, two of which are used for injectables, while the other specializes in solid 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
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:
Syringes
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.
Mostrar CertificacionesINJECTABLES PLANT
San Sebastián de los Reyes
Annual production capacity:
Syringes
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:
Tablets
Hard Capsules
Sachets
Storage capacity:
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.
OUR BEMIPARIN
MANUFACTURING PLANT.
Granada
I+D+i
Annual production capacity:
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.
Water for Injection (WFI)
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