Rovi CM - Contract Manufacturing of Parenterals in Pre-Filled Syringes and Vials

With 50 years of experience manufacturing injectables, Rovi began offering contract manufacturing services in 1995. With four high-speed filling lines, we are one of largest worldwide specialists in the preparation, filling under aseptic conditions and/or terminal sterilisation for parenterals in pre-filled syringes and vials.

GMP-approved contract manufacturing of parenterals

At Rovi CM, quality is the top priority to satisfy the needs and requirements of our international clients. The Rovi CM manufacturing site has been GMP-approved since May 1994. We also comply with and own many additional quality certifications, including:

• MHRA
• Korean FDA
• Gulf Countries HHAA
• ANVISA (Brazil)
• ISO 9,001, 14,001
• OSHAS 18,001

In a continuous effort towards quality improvement and compliance with global companies' expectations, Rovi CM is entering into the last stages of an FDA approval process.

QA services

All laboratory services, including compatibility and stability studies, are available to all customers, independently of any other service contracted.

Our new quality building includes two independent laboratories (QC and microbiology) to cover 24hr production activities. Both laboratories are run by highly qualified people and are fully equipped with top-quality instrumentation.

Small-volume parenterals in prefilled syringes and vials

Since 1994 we have specialised in processing small-volume parenterals in prefilled syringes and vials. Since 2005 we have worked with four top-class high-speed filling lines to ensure flexibility and capacity. Total filling capacity is about 220 million units per year.

Our large production equipment associated with three shifts organisation allows us to maintain significant extra capacity to satisfy increasing customer demands.

All prefilled syringe (PFS) formats are available from 0.5ml to 20ml. The PFS are filled from 0.2ml to 20ml. To comply with product specifications as well as customer needs, all PFS formats are readily available.

High-speed packaging lines for syringes and vials

We can package all syringes and vials processed in our plant with fully automatic or semiautomatic blistering and boxing machines.

Terminal sterilisation for syringes and vials

To comply with EP and USP guidelines we offer the possibility to apply terminal sterilisation on syringes and vials with a state-of-the-art counter pressure autoclave.

Safety device assembly for prefilled syringes

In many countries, safety legislations are making the use of integrated protection systems mandatory in order to minimise the risk of accidental needle punctures. We offer the possibility of assembling safety devices on PFS with our new assembly equipment.

Diluent syringes

Rovi CM is able to provide water for injection (WFI) syringes in different sizes and volumes (EP and USP). A common technical dossier (CTD) module 3 and a drug master file (DMF) can be proposed to our WFI customers at no cost in order to facilitate the registration process.

Shelf-life: three years

Syringe types and volumes:

• 1ml filled at 0.5ml
• 1.25ml-1.5ml filled at 1ml
• 3ml filled at 2ml
• 10ml filled at 5ml and 10ml
• 20ml filled at 15ml and 20ml

Rovi CM is committed to quality production and reliable results. Through our everyday efforts we ensure that our products are of the highest standards and meet worldwide regulations, so that working with us will only add value to your company and provide the results you seek.

Qualified contract manufacturing professionals

All Rovi CM personnel are perfectly qualified by education. A well documented internal training system is in place to maintain and increase individual and global performance. Rovi CM know-how and knowledge is enhanced by a very low staff turnover.

All services provided by Rovi CM are available independently:

• Clinical trials
• Industrial development support
• Regulatory support
• Suppositories (in aluminium blisters): 150 million units per year

About Rovi Group

The larger branch of Rovi Group is a fully-integrated, Spanish speciality pharmaceutical company. Laboratorios Farmacéuticos Rovi is engaged in the research, development, manufacturing and marketing of small molecules and speciality biologic drugs. The company was created in 1946 and has been quoted on the Madrid Stock Market since 2007. Revenues from 2010 were €158.6m listed and taken count with over 800 employees.

We are known for our flexibility, transparency, expertise and constant dedication. We work hard to make every client feel like our most important one. Rovi CM: your medium-sized partner for exceptional companies.