ROVI CM

Contract Manufacturing Services for Injectable and Solid Forms

Contract manufacturing services for injectables

ROVI CM provides contract manufacturing services for injectables, including pre-filled syringes (PFS), vials, and tablets for pharmaceutical manufacturing plants.

Manufacturing, testing and packaging for the pharmaceutical industry

ROVI has US Food and Drug Adiministration (FDA) approved and good manufacturing practice (GMP) certified production plants in Spain and has an annual capacity of 250 million PFSs, 60 million vials, and three billion tablets.

Manufacturing plants for injectables

ROVI has a high-quality injectables plant certified by the FDA, Agência Nacional de Vigilância Sanitária (ANVISA, Brazil), Korea Food and Drug Administration (KFDA), Medicines and Healthcare Products Regulatory Agency (MHRA) and the Spanish Agency of Medicines and Medical Devices (AEMPS).

The plant is also approved by Gulf co-operation countries and holds several ISO certifications.

Pre-filled syringes, vials and suppositories

Drug products manufactured in the company's pharmaceutical plant are currently exported to more than 50 countries worldwide. ROVI's core business is filling and packing small volume parenterals (SVP) in PFS and vials.

The company covers all syringe formats available in the market from 0.5ml to 20ml, which can be filled to the same limits. Vials are available from 2ml to 10ml.

Water for injection

ROVI's injectables plant offers sterile, prefilled water for injection (WFI) and syringes for reconstitution / dilution drug products.

Ready to submit documentation (common technical document (CTD) Module 3 & drug master file (DMF)) is available for Europe and the US (with stability data ICH) to facilitate registration and speed up product launches.

Clients can choose the volume required, including:

  • 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

Solid forms plant

ROVI's plant is one of the biggest FDA approved plants for solid forms in Europe at 83,000m².

The plant has been certified by various agencies, including the FDA, ANVISA, AEMPS, and Gulf co-operation countries. It is also certified by Comisión Federal Para la Protección Contra Riesgos Sanitarios (COFEPRIS, Mexico), the National Institute of Health Sciences (NIHS, Japan), and meets Belarusian and Kenyan standards.

Tablets, coated tablets and hard capsules

ROVI exports 75% of its production and serves 50 markets with 25 different languages. The company's core business is specialising in manufacturing and packaging solid form pharmaceuticals.

Contact Details

Rovi Contract Manufacturing
C/ Julián Camarillo, 35
28037 Madrid
Spain
Contact: Mr César López de Hierro - Contract Manufacturing Product Manager
+34 91 375 62 45
+34 91 375 63 51
clopezdehierro@rovi.es
www.rovicm.es

Available White Papers

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ROVI: What You Imagine, We Make A Reality 20 September 2017 ROVI has more than 50 years' manufacturing experience for pharmaceutical products. It began providing contract manufacturing services in 1995 and now has several high-speed filling lines.