ROVI CM - Contract manufacturing Services for injectables and solid forms in our two FDA-approved & GMP-certified manufacturing plants.
Manufacturing / Testing / Packaging
Annual capacity of 180 million Prefilled syringes, 40 million vials, 3 billion tablets.
a) Injectables plant
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.
Pharmaceutical Form: Prefilled syringes, vials and suppositories
Currently, the drug products manufactured in this plant are exported to over 50 countries worldwide.
Core business: Specialist in filling and packaging of SVP (small volume parenteral) in prefilled syringes and vials. We cover all syringe formats available in the market from 0.5 ml up to 20 ml (it is filled from 0.2ml up to 20ml). Vials format from 2ml to 10ml.
Manufacturing - testing - packaging and storage
PFS and Vials:
Flexibility and versatility are offered. We customize our services taking into accounts our client's needs.
Flexible filling lines
Since 2005 we work with top class filling lines. All of them obtained from the leading machinery supplier in pharmaceutical industry.
Free filling capacity allows us to maintain significant extra capacity to satisfy increasing customer needs.
Terminal sterilization (optional service)
To comply with EP and USP guideline we offer terminal sterilization services as part of the whole manufacturing process requirements, or as a single service.
Labelling machines for syringes and vials are available. All of them use last generation inspection systems. Multiple languages can be used.
Safety devices assembly
In many countries safety legislations are making mandatory the use of integrated protection systems to minimize the risk of accidental needle sticks.
Injectables plant offers the possibility to assemble safety devices on prefilled syringes with a new fully automatic assembly equipment.
High speed packaging lines
We can package all syringes and vials processed in our plant with blistering and boxing machines.
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 syringes; 1ml WFI in 1.25ml syringes; 2ml WFI in 3ml syringes; 5ml WFI in 10ml syringes ; 10ml WFI in 10ml syringes ; 15ml WFI in 20ml syringes ; 20ml WFI in 20ml syringes
We also have facilities for manufacturing and packaging suppositories in aluminium blister.
Annual capacity is about 150 million suppositories.
b) Solid forms plant
This plant is one of the biggest FDA-approved plant for solid forms in Europe with 83,000 m2
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% of its production and serves 50 markets within 25 different languages.
Core business: specialist in manufacturing and packaging solid forms of land.
Manufacturing - testing - packaging
High capacity Roller Compactor (dry granulation)
The highest quality tablets through our High Shear granulation systems (wet granulation), including fluid bed drying, milling and ribbon blending
Double side compression presses available to provide flexible as well as large volume production
Film coaters to cover different bach sizes
Huge total and free capacity available to comply with medium to very large production. Batches from 100 kg up to 1,000 kg
A fully equipped laboratory to provide quick and reliable results (with chemical and microbiological capabilities)
Flexible and large volume packaging equipment available to fulfill various customer needs
- 16 packaging line have been installed including high speed lines and very flexible lines for customized presentations providing capability for Alu-Alu, PVC-Alu, PVDC-Alu
- No minimum batch size
- Blister or aluminum pouches
- High tech vision system, cartooning, labeling, marketing, overwrapping and casepacking capability for each packaging line
Capsules blistering also possible
Integrated storage capability through our sizeable warehouse (9,000 pallets) which includes a cold room at 2 to 8 ºc (400 pallets)
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 chromatography
- Atomic absorption spectroscopy
- Ultraviolet spectroscopy
- Near infra-red spectroscopy
- Fourier transform IR spectroscopy
- Wet chemistry
Integrated 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.
- Core Sales Territory:
Global Regulated Markets
- Formed: 1946
- Number of employees: 800+