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About Rovi CM
offers Contract Manufacturing Services for
injectables and solid forms and WFI; FDA-approved &
GMP-certified manufacturing plants. Annual capacity
of 300 million
prefilled syringes, 120 million vials, 3 billion tablets,
130 million boxes, 50 million
sachets and 500
million hard capsules.
Exceptional 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.
Core Business: Specialist in aseptic filling and packaging of SVP (small volume parenteral) in prefilled syringes and vials as well as Vaccines (RNA vaccines among others). We cover all syringe formats available in the market from 0.5 ml up to 20 ml (filled from 0.2ml up to 20ml). Vials format from 2ml to 10ml.
Water for injections (WFI)
ROVI also 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 ICH) to facilitate the registration and speed up your product launch.
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.
ROVI exports 75% of its production and serves more than 50 markets within 25 different languages.
Products from Rovi CM
Specialist in filling and packaging SVP (small volume parenteral) in prefilled syringes and vials. Our injectable plants exportto over 50 countries worldwide.
- 5 high speed lines for syringes (aseptic filling)- 3 high speed lines for vials (aseptic filling)
- Terminal sterilization
- Fully equipped with ultimate technologyof labelling, packaging and serialization
- 6 high-speed blister lines
- 4 flexible blister lines
Rovi offers contract manufacturing services which includes quality/testing. It belongs to solid forms plant category. Features: high performance liquid chromatography (hplc), gas chromatography, atomic absorption spectroscopy, ultraviolet spectroscopy, near infra-red spectroscopy, fourier transform ir spectroscopy, wet chemistry, reduce variability and increase efficiency - six sigma, reduce cycle time and eliminate non value added activities - lean manufacturing, etc.
Our solid forms plant exports 75% of its output, supplying products to 45markets in 25 different languages.One of the biggest FDA-approved plant for solid forms in Europe with an annual capacity of 3 billion tablets. We use the latest technology to produce high-quality products ata very competitive Price.Latest technology for manufacturing, blistering, and packaging high-quality products.Quality control and Microbiology lab fully equipped
• High capacity Roller Compactor• High Shear Granulation• Film Coaters
• High speed and flexible Packaging lines(Alu-Alu, PVC-Alu, PVDC-Alu) and serialization.
• 4 high-speed blister lines• Several flexible blister lines and sachet lines
• Blister or aluminum pouches
• High tech vision system
Rovi offers contract manufacturing services which includes storage and logistics. It belongs to injectables plant category. Features: finished product warehouse at room or cold temperature, capacity of 400 palets for semi-finished product y packaging materials. There are two movil shelves rack and several authomatized kardex, besides it is available raw material warehouse with room temperature, 2-8ºc, -25ºc y -80ºc, etc.
Rovi offers Water For Injection (WFI) in prefilled syringes in different sizesand volumes, produced according to European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP) requirements.Module 3 common technical document (CTD) dossiers and drugmaster files (DMF) are available toour WFI clients at no additional cost in order to facilitate the registration process.
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