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.

Make an enquiry

Follow this company

Follow the company to be always up to date with this company

Press Release

Rovi CM to Attend Industry Events Throughout 2011

Rovi CM and Rovi Alcala will attend several events during 2011. Visit them at: Strategies in Pharma Outsourcing, Berlin, Germany, 25-26 May Global Pharma Manufacturing Summit, New Jersey, US, 20-21 June BIO Washington, Washington, US, 27-30 June - Spanish Pa

White Papers

ROVI: What You Imagine, We Make A Reality

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.

Address
Rovi Contract Manufacturing

C/ Julián Camarillo, 35

28037 Madrid

Other

Spain

+34 91 375 62 45 +34 91 375 63 51 www.rovicm.es

ROVI CM Images

Products and Services

Video

Press Release

20 September 2017

Laboratorios Farmacéuticos Rovi (ROVI) has announced that the US Food and Drug Administration (FDA) has approved its contract manufacturing injectables plant in Madrid for filling syringes that are prefilled with water for injection using the terminal sterilisation process.

Read more
7 April 2016

Rovi CM will be attending to Interphex 2016 from 26-28 April and will be available at stand 1125.

Read more
28 September 2014

Rovi CM is to host a stand at the forthcoming CPhI event in Paris, France.

Read more
13 July 2014

ROVI CM has acquired a new hard capsules filling line at its FDA-approved and GMP-certified solid manufacturing plant, expanding contract manufacturing services.

Read more
23 September 2013

ROVI CM is to host a booth at CPHI in Frankfurt in October.

Read more
11 May 2011

Rovi CM and Rovi Alcala will attend several events during 2011. Visit them at: Strategies in Pharma Outsourcing, Berlin, Germany, 25-26 May Global Pharma Manufacturing Summit, New Jersey, US, 20-21 June BIO Washington, Washington, US, 27-30 June - Spanish Pa

Read more

Regional Offices

Rovi Contract Manufacturing

C/ Julián Camarillo, 35

28037 Madrid

Other

Spain

+34 91 375 62 45 +34 91 375 63 51 www.rovicm.es

Contact company

I have read and accept the terms and conditions and privacy policy.
We'd like to keep you informed about relevant promotions, products and services, if you would like not to receive these, check this box.
If you would like to hear from carefully selected third party companies, check this box
Follow this company to receive notifications when they update.