ROVI Contract Manufacturing

Contract manufacturing and pharmaceutical co-development services offered through our 2 manufacturing plants located in Madrid, Spain (ROVI CM & ROVI Alcala). The manufacturing plants focused in injectables (prefilled syringes and vials) and solid forms, belong to Laboratorios Farmacéuticos ROVI: pharmaceutical company founded in 1946 and listed in the Madrid Stock Exchange Market since 2007. Revenues from 2011 were 184.7€ M and it takes count with over 840 employees.

• CONTRACT MANUFACTURING:

1. ROVI CM, with more than 16 years of experience and GMP, MHRA, KFDA, Gulf Countries HHAA and ISO certifications, is specialized in filling small volume parenterals in Pre-filled syringes (PFS), vials. Annual capacity of 180 million PFS's, 40 million vials. ROVI CM currently exports to European, Asian, Latin American, African and the Middle Eastern markets.

All formats syringe volume available from 0.5ml to 20ml (filled from 0.2ml to 20ml) and vials from 2ml to 7ml. What follows are some of services we offer:

- Terminal sterilization with a state of the art counter pressure autoclave
- Assembly of safety devices on PFS with our fully-automatic assembly equipment
- Water for injection (WFI) syringes in different sizes and volumes following European and US Pharmacopoeia requirements. A CTD module 3 and a DMF can be offered at no extra cost
- Blistering, packaging and labelling services
- Finally, we have capacity to manufacture and package suppositories in aluminium blister. Annual capacity: 150 million units

2. ROVI Alcala, one of the largest European state-of-the-art FDA-approved plants for solids. Annual capacity: 3,000 million tablets. The 83,000m2 plant was acquired in 2010 from the Merck Sharp and Dohme group. We also hold Brazilian (ANVISA), Japanese, Mexican, Gulf Countries approvals and GMP-certified. Products manufactured by ROVI Alcala are distributed in more than 40 countries.

Specialized in manufacturing, testing and packaging of solid forms (tablets with or without film coating):

- Highly competitive price thanks to our large capacity Roller Compactor (dry granulation)
- High Shear and Low Shear granulation systems (wet granulation), including fluid bed drying, milling and ribbon blending
- Planetary mixers

• PHARMACEUTICAL CO-DEVELOPMENTS
In order to increase the manufacturing of both facilities (ROVI CM and ROVI Alcala), it offers Co-Development services (initial model):
1.Partner chooses and provides the API
2.We offer from pre/formulation, scale up, stability batches, regulatory batches, bioequivalence studies if necessary, dossier compilation to manufacturing industrial batches.
3.Licensing: directly through partner or out-licensing.

We are committed to ensure a personalized service to each partner so we can adapt to variations in our initial Co-development model.
The model proposed is a Virtual joint venture with a Cost-Profit sharing approach.

ROVI Alcala & ROVI CM: your medium-sized partner for exceptional companies