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Rovi CM / Rovi Alcala - Research, Development, Manufacturing and Marketing Services

The larger branch of Rovi Group is a fully-integrated Spanish specialty pharmaceutical company engaged in the research, development, manufacturing and marketing of small molecules and speciality biologic drugs. Due to our flexibility, transparency, expertise and constant dedication, we work hard to make every client feel like our most important one.

Contract manufacturing services offered through our two manufacturing facilities

Rovi CM, with 50 years of experience manufacturing injectables, Rovi began offering contract manufacturing services in 1995 and it has GMP certificate and is a FDA-approved plant. We also comply with and many additional quality certifications, including: MHRA, Korean FDA, Gulf Countries HHAA, ANVISA (Brazil), ISO 9,001, 14,001 and OSHAS 18,001.

The annual capacities are 180 million PFS's, 40 million vials and 150 million suppositories units in aluminium blister. RoviCM currently exports to European, Asian, Latin American, African and the Middle Eastern markets.

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 (Volume: 0.5ml-20ml. Filled from 0.2ml to 20ml) and vials, in sterile areas. Besides, the following is possible:

  • Terminal sterilization performed in our 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 to our WFI customer at no extra cost
  • Blistering, packaging and labelling services

Your medium-sized partner for exceptional companies

Rovi Alcala, one of the largest European state-of-the-art FDA approved plants for solids. It has a global capacity of 3,000 million tablets/year and supplies to major markets.

The 83,000m2 plant was acquired in 2010 from the Merck Sharp and Dohme group, which had been manufacturing and packaging pharmaceutical products since 1969 with high compliance and a history of productivity, performance and quality. We also hold Japanese, Mexican, Brazilian and Gulf countries approvals and GMP certificate. Thanks to such an extensive track record of certifications, products manufactured by Rovi Alcala are distributed in more than 40 countries.

Specialised in manufacturing, testing and packaging solid forms (tablets with or without film coating), we provided a complete service: production-testing-packaging-storage with:

  • Low production costs with 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
  • Different compression bays for direct and granulation compression
  • Quality lab in a separate building (4,600 m2) including Microbiology and Chemistry labs and Quality Assurance offices
  • Chemical testing capabilities (NIR, HPLC, gas chromatography, Biomek and more)
  • Microbiological testing capabilities
  • Different high speed, flexible and semiautomatic blistering lines
  • Cartoning, labelling, marking, overwrapping and casepacking capabilities for every packaging line equipped with high tech vision systems
  • Datamatrix
  • Enough capacity to comply with medium to very large production
  • Batches from 100kg-1,000kg
  • Simplified storage management through our warehouse (8,000 pallets) including a cold room at 2 to 8 C° (400 pallets)
  • Integrated management system including: 6 sigma, Lean manufacturing, 5S, Visual management, Lean management and Quality Management System

Rovi Contract Manufacturing 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.

Contact

César Lopez de Hierro
Contract Manufacturing Product Manager
clopezdehierro@rovi.es
www.rovicm.es