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Rovi CM / Rovi Alcala

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Rovi CM / Rovi Alcala

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

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Manufacturing Plants

Injectables plantExceptional quality level which has been certified by various agencies such as FDA (USA), ANVISA (Brazil), KFDA (Korea), MHRA (UK), AEMPS (Spain), Gulf Cooperation Countries and several ISO certifications.Pharmaceutical Form: Prefilled syringes, vials and suppositoriesCurrently, the drug products manufactured in this plant are exported to over 50 countries worldwide.Core business: Specialist in filling and…

Quality Control & Microbiolgy Lab

Our quality department has dedicated building (4,600 m²) which includes Microbiology lab, Chemistry lab and Quality Assurance department.

Complete equipment up-to-date:High performance liquid chromatography (HPLC)Gas chromatographyAtomic absorption spectroscopyUltraviolet spectroscopyNear infra-red spectroscopyFourier transform IR spectroscopyWet chemistryIntegrated management system including: Six Sigma, Lean Manufacturing), 5S, Visual Management and QMS (Quality Management system) to ensure reliable and consistent quality as well as compliance with global regulatory requirements.

Suppositories

Facilities for manufacturing and packaging suppositories in aluminium blister with an annual capacity of around 150 million suppositories.

Solid forms plantThis plant is one of the biggest FDA-approved plant for solid forms in Europe with 83,000 m2 of land. Exceptional quality level which has been certified by various agencies such as FDA (USA), ANVISA (Brazil), AEMPS (Spain), COFEPRIS (Mexico), NIHS (Japan), Gulf Cooperation Countries, Belarusian, Kenyan.Pharmaceutical forms: Tablets, Capsules, Powder, Granules...It exports 75%…

Water for Injections

Injectables plant offers sterile, prefilled water for injection (WFI) syringes for reconstitution/dilution of drug products.

Ready to submit documentation (CTD Module 3 & DMF) are available for Europe and the US (with stability data) to facilitate the registration and speed up your product launch.You can choose the volume you desire:0.5ml WFI in 1ml STD syringes1ml WFI in 1.25ml syringes2ml WFI in 3ml syringes5ml WFI in 10ml syringes10ml WFI in 10ml…
Quick Contact Rovi CM / Rovi Alcala
Quick Contact Rovi CM / Rovi Alcala
Quick Contact Rovi CM / Rovi Alcala


Quick Contact Rovi CM / Rovi Alcala
Quick Contact Rovi CM / Rovi Alcala
Quick Contact Rovi CM / Rovi Alcala


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