Industrial footprint
ROVI has five fully-consolidated industrial complexes, two of which are engaged in the manufacture of injectable products (Madrid and San Sebastián de los Reyes, while a third specialises in oral solid forms and assembly and packaging (Alcalá de Henares). Among the three, they combine decades of experience working to the highest quality standards and allow ROVI to offer a wide range of services to its clients.
The high capacity of its facilities allow ROVI to offer a wide range of services, including formulation, sterile filling and terminal sterilisation, inspection, placing safety devices in syringes, labelling, packaging, serialisation and aggregation, in relation to various injectable pharmaceutical forms, such as prefilled syringes, vials and cartridges, as well as manufacturing and packaging services for solid products.
CDMO
ROVI is committed to investing in its contract manufacturing business to increase its production capacity for high-value-added injectables and diversify its manufacturing formats (prefilled syringes, vials and cartridges) to provide a response to the current imbalance between the supply and demand for innovative products and biosimilars, which are leading the expansion in the injectables sector.
Why we stand out
Three industrial complexes
We have three contract manufacturing facilities: two engaged in the manufacture of injectables and the other specialising in oral solid forms and assembly and packaging.
Variety of pharmaceutical forms
We offer a wide range of pharmaceutical forms, including prefilled syringes, cartridges, vials, tablets and sachets.
All services within the same company
We provide the possibility of unifying all the services within the same company, starting with the development of a project and continuing until the final release of the product, including the prior clinical trials, stability studies, and physicochemical and microbiological analyses, with the resulting saving of time and money for the customer. Thus, a personalised service is offered depending on each customer’s needs.
Own product manufacturing
In addition to the three contract manufacturing production facilities, we have two facilities to 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.
Water for Injection (WFI)
The injectables facility offers our customers syringes prefilled with water for injectables (WFI - Water for Injections) in different sizes and volumes, produced in accordance with the requirements of the European and United States Pharmacopoeias.
To facilitate the registration process for our customers, Module 3 (Common Technical Dossier) and the DMF (Drug Master File) are provided free of charge.
Shelf life: 3 years
Syringe and volumes:
- 1.25 ml filled from 0.5 ml to 1 ml. Bracketing strategy that covers all fill volumes between 0.6 and 1 ml.
- 3 ml filled with 2.18 ml.
- 10 ml filled from 5 to 10 ml. Bracketing strategy in all volumes from 5 to 10 ml.
- 20 ml filled with 15 and 20 ml.