LABORATORIOS FARMACEUTICOS ROVI S.A

Laboratorios Farmacéuticos ROVI S.A., commonly known as ROVI, is a Spanish pharmaceutical company headquartered in Pozuelo de Alarcón, Madrid. Founded in 1946, the company developed from a business model centered on the Spanish commercialization of medicines from international pharmaceutical companies into an integrated group covering pharmaceutical research, development, manufacturing, licensing, distribution and contract development and manufacturing services. ROVI is publicly traded in Spain under the ticker ROVI and remains controlled by the López-Belmonte family through Norbel Inversiones, S.L. ROVI’s historical specialization is anticoagulation. The company began researching low-molecular-weight heparins in 1981 and later developed bemiparin, marketed principally under the Hibor brand. Bemiparin became the company’s main proprietary product and the foundation of its international expansion. ROVI subsequently added an internally developed enoxaparin biosimilar and other heparin-related products. Its heparin franchise is marketed directly or through partners in numerous countries and remains one of the group’s central specialty-pharmaceutical businesses. The company also maintains a broad portfolio of proprietary and licensed prescription products. Its therapeutic coverage includes cardiovascular medicine, thrombosis, respiratory disease, urology, osteoarticular conditions, pain management, endocrinology, central nervous system disorders, primary care and diagnostic imaging. Licensed products have included medicines and hospital products from companies such as Novartis, MSD, Astellas and Bracco. This portfolio gives ROVI a diversified commercial base in Spain and selected European markets rather than relying exclusively on a single research product. A major strategic development has been ROVI’s ISM drug-delivery platform. ISM is a proprietary long-acting injectable technology designed to release active pharmaceutical ingredients over extended periods and potentially reduce dosing frequency. The first marketed product based on this platform is risperidone ISM, sold in Europe as Okedi for adults with schizophrenia for whom oral risperidone tolerability and effectiveness have been established. European authorization was obtained in 2022, followed by launches in several European countries. The product and related development programs have shifted ROVI’s profile toward specialty medicines with proprietary technology and international growth potential. ROVI has also become a significant contract manufacturing organization. Through ROVI Pharma Industrial Services and related facilities, it provides manufacturing, aseptic filling, inspection, labeling, packaging and other services for sterile injectables, prefilled syringes, vials and oral solid forms. The company’s production network in Spain has been used by multinational pharmaceutical partners for vaccines, biologics, biosimilars and other complex products. Its collaboration with Moderna during the COVID-19 pandemic made ROVI an important European fill-and-finish and drug-substance manufacturing partner for Moderna’s mRNA vaccine outside the United States. The relationship was extended in 2022 through a long-term agreement covering additional capacity and future mRNA medicines. ROVI’s business model therefore combines three mutually reinforcing activities: specialty pharmaceuticals sold under its own brands or licenses, research and development based on heparin science and the ISM platform, and CDMO services for other pharmaceutical companies. The group operates in Spain through its principal commercial, research and manufacturing infrastructure and has subsidiaries or commercial operations across several European countries. Its present positioning is that of a specialized, vertically integrated European pharmaceutical company with particular strengths in injectable products, anticoagulation, long-acting drug delivery and sterile manufacturing.

ROVI traces its corporate history to 1946, when the company was established in Spain to commercialize pharmaceutical specialties, including products supplied under license by international pharmaceutical companies. The business gradually developed a proprietary research and manufacturing base, with heparin science becoming its most important long-term specialization. ROVI began research into low-molecular-weight heparins in 1981, establishing the scientific and commercial foundation for its later development of bemiparin. The company introduced bemiparin into the Spanish market in 1998 and began activities in Portugal during the same period. Bemiparin, later marketed primarily as Hibor, became ROVI’s principal proprietary medicine and supported expansion beyond Spain. In 2002, the product began receiving approvals in international markets, and by 2003 ROVI reported coverage in 59 countries. The company’s heparin franchise subsequently expanded through international licensing, distribution and commercialization arrangements. ROVI invested in its own research and industrial infrastructure during the 2000s. In 2006 it built a research and development center and a manufacturing facility in Granada. The company also broadened its portfolio through agreements with international pharmaceutical companies. Agreements with Laboratoires Servier, MSD, Novartis, Astellas, Bracco and other partners allowed ROVI to market medicines in cardiovascular care, respiratory medicine, urology, diagnostic imaging and other fields. These arrangements complemented the company’s own products and reduced reliance on a single therapeutic area. In 2007, ROVI became a publicly traded company in Spain. The listing provided access to capital and increased the group’s visibility as it expanded its commercial and manufacturing activities. ROVI continued strengthening its European presence, establishing or developing operations in countries including France, Germany, Italy, Portugal, the United Kingdom and Poland. In 2012, one of its injectable facilities received U.S. FDA certification, an important step in developing a global manufacturing and regulatory platform. A further milestone came in 2015, when ROVI acquired an injectable manufacturing facility in San Sebastián de los Reyes and entered into a strategic agreement with Astellas in urology. In 2017, the company received a positive European regulatory outcome for its internally developed enoxaparin biosimilar in a decentralized procedure using Germany as reference member state. The product was launched first in Germany and later in the United Kingdom, extending ROVI’s heparin franchise beyond bemiparin. ROVI’s research strategy increasingly emphasized proprietary delivery technologies. The company developed ISM, a long-acting injectable platform intended to control drug release and reduce the frequency of administration. Its first commercial product using the platform was risperidone ISM, marketed as Okedi in Europe. Following regulatory work that began in the late 2010s, the European Commission authorized Okedi in 2022. Launches followed in Germany, the United Kingdom, Spain and additional European markets. The platform became a central part of ROVI’s effort to evolve from a regional specialty-pharmaceutical company into an international developer of differentiated injectable medicines. The COVID-19 pandemic accelerated the development of ROVI’s contract manufacturing business. In 2020, ROVI and Moderna agreed that ROVI would manufacture and perform fill-and-finish activities for Moderna’s mRNA-1273 COVID-19 vaccine for markets outside the United States. ROVI completed its first European batches in January 2021. Additional investment at the Granada site supported active-substance manufacturing, while Madrid-area facilities performed compounding, filling, inspection and packaging operations. In February 2022, ROVI and Moderna extended their relationship through a ten-year agreement to expand capacity and potentially support future mRNA medicines. The Moderna relationship also brought regulatory and operational scrutiny. In August 2021, Japan suspended use of three Moderna vaccine lots after foreign particulate matter was found in some vials. ROVI participated in the investigation with Moderna, Takeda and Japanese and European authorities. The subsequent investigation attributed the particles to a manufacturing-line issue involving friction between metal components in a capping module. The affected lots were recalled as a precaution, and the episode became the most prominent quality incident associated with ROVI’s public profile. ROVI continued expanding its manufacturing capabilities after the pandemic. In 2023, the U.S. FDA approved several Spanish facilities for syringe fill-and-finish of Moderna’s vaccine for the U.S. market, and in January 2024 the Granada plant received FDA approval for manufacture of the active ingredient. In April 2024, ROVI announced another prefilled-syringe manufacturing agreement with an unnamed global pharmaceutical company. These developments reflected a strategic emphasis on sterile injectables, prefilled syringes, biologics, biosimilars and other complex products where manufacturing capacity and regulatory expertise are important competitive advantages. The company’s governance has remained closely associated with the López-Belmonte family. Juan López-Belmonte Encina became CEO in 2007 and was appointed chairman in 2021 following the death of his father and former chairman, Juan López-Belmonte López. Javier López-Belmonte Encina serves as first vice-chairman and chief financial officer, while Iván López-Belmonte Encina serves as second vice-chairman and oversees commercial and business development activities. Through Norbel Inversiones, the family remains the controlling shareholder while ROVI continues to operate as a listed company. Today, ROVI combines a specialty-pharmaceutical portfolio, a global low-molecular-weight-heparin franchise, the ISM long-acting injectable platform and an expanding CDMO operation. Its manufacturing and research base remains concentrated in Spain, while its commercial reach extends across Europe and selected international markets.

• 2024

  ROVI expands prefilled-syringe CDMO activity

  [12]ROVI prefilled-syringe manufacturing agreementrovi.es

  ROVI Pharma Industrial Services signs an agreement to support manufacture of prefilled syringes for a global pharmaceutical company.

• 2023

  U.S. FDA approves ROVI facilities for Moderna syringe fill-and-finish

  [19]U.S. FDA approves ROVI facilities for Moderna syringe fill-and-finishrovi.es

  Several Spanish injectable facilities receive FDA approval for fill-and-finish of Moderna’s vaccine in prefilled syringes.

• 2022

  Okedi receives European authorization

  [18]Okedi receives European authorizationrovi.es

  The European Commission authorizes Okedi, the first commercial medicine based on ROVI’s ISM technology.

• 2022

  ROVI and Moderna sign a ten-year manufacturing agreement

  [11]ROVI and Moderna ten-year manufacturing agreementrovi.es

  The companies extend their collaboration and plan investments to increase mRNA vaccine manufacturing capacity in Spain.

• 2021

  First Moderna vaccine batches are completed

  [10]ROVI completes first Moderna vaccine batchesrovi.es

  ROVI completes the first batches of Moderna’s COVID-19 vaccine for the European Union.

• 2021

  Juan López-Belmonte Encina becomes chairman

  [17]Juan López-Belmonte Encina becomes chairmanrovi.es

  ROVI’s CEO becomes chairman after the death of former chairman Juan López-Belmonte López.

• 2020

  Moderna manufacturing collaboration begins

  [9]ROVI and Moderna fill-and-finish collaborationrovi.es

  ROVI and Moderna agree on European fill-and-finish manufacturing for Moderna’s COVID-19 vaccine.

• 2017

  Enoxaparin biosimilar receives European authorization

  [16]Enoxaparin biosimilar receives European authorizationrovi.es

  ROVI obtains a positive decentralized European regulatory outcome for its enoxaparin biosimilar, later launching it in Germany and the United Kingdom.

• 2015

  San Sebastián de los Reyes injectable facility is acquired

  [15]Injectable facility receives FDA certificationrovi.es

  ROVI acquires an injectable manufacturing plant and signs a strategic urology agreement with Astellas.

• 2012

  Injectable facility receives FDA certification

  [15]Injectable facility receives FDA certificationrovi.es

  ROVI obtains U.S. FDA certification for an injectable manufacturing facility.

• 2007

  ROVI is listed on the Spanish stock market

  [7]ROVI corporate governance compositionrovi.es

  ROVI becomes a publicly traded company in Spain and Juan López-Belmonte Encina becomes chief executive officer.

• 2006

  Granada research and manufacturing infrastructure is built

  [1]ROVI corporate historyrovi.es

  ROVI builds a research and development center and a factory in Granada.

• 2003

  International coverage reaches 59 countries

  [1]ROVI corporate historyrovi.es

  The company reports expansion of its international presence to 59 countries.

• 2002

  Internationalization begins

  [1]ROVI corporate historyrovi.es

  ROVI expands internationally through foreign approvals and commercialization of bemiparin.

• 1998

  Bemiparin enters Spain

  [1]ROVI corporate historyrovi.es

  Bemiparin is introduced to the Spanish market and ROVI begins activities in Portugal.

• 1981

  Low-molecular-weight heparin research begins

  [1]ROVI corporate historyrovi.es

  ROVI begins research into low-molecular-weight heparins, laying the foundation for its bemiparin franchise.

• 1946

  ROVI is founded

  [1]ROVI corporate historyrovi.es

  Laboratorios Farmacéuticos ROVI is established in Spain to commercialize pharmaceutical specialties and develop its own pharmaceutical activities.

A specialized, vertically integrated European pharmaceutical group combining proprietary specialty medicines, licensed products, low-molecular-weight heparins, long-acting injectable drug delivery and high-complexity contract manufacturing.

• Low-molecular-weight heparin · 1998

  Hibor

  Hibor is ROVI’s principal proprietary brand for bemiparin sodium, a low-molecular-weight heparin used in thrombosis prevention and treatment settings. Bemiparin originated from ROVI’s own research program and became the company’s most important long-established specialty medicine. The brand is commercialized in Spain and numerous international markets through ROVI subsidiaries and strategic partners.

• Biosimilar anticoagulant · 2017

  Enoxaparin ROVI

  Enoxaparin ROVI is an internally developed biosimilar version of enoxaparin sodium. It extends ROVI’s anticoagulation expertise beyond bemiparin and has been approved and commercialized through European and international distribution arrangements. The product is part of ROVI’s strategy to build a broader low-molecular-weight-heparin franchise.

• Long-acting injectable antipsychotic · 2022

  Okedi

  Okedi is the commercial name for risperidone ISM, ROVI’s first marketed product based on its proprietary ISM long-acting injectable platform. It is indicated in Europe for adults with schizophrenia for whom tolerability and effectiveness with oral risperidone have been established. The formulation is designed to provide sustained drug release through periodic injection rather than daily oral dosing.

• Cardiovascular prescription medicine

  Neparvis

  Neparvis is ROVI’s licensed presentation of sacubitril and valsartan, a cardiovascular medicine commercialized under agreement with Novartis Europharm. It represents the company’s strategy of combining proprietary products with selected licensed medicines in therapeutic areas where ROVI has established commercial and medical capabilities.

• Cardiovascular prescription medicine

  Orvatez

  Orvatez combines ezetimibe and atorvastatin and is marketed by ROVI under license from MSD. The product belongs to the company’s cardiovascular portfolio and complements its proprietary heparin products and other licensed therapies.

• Urology prescription medicine · 2015

  Volutsa

  Volutsa combines solifenacin succinate and tamsulosin hydrochloride for urinary symptoms associated with benign prostatic hyperplasia. ROVI distributes the Astellas product in Spain and uses it as part of its urology franchise.

• Ultrasound contrast agent

  Sonovue

  Sonovue is a Bracco-licensed diagnostic imaging product marketed by ROVI for ultrasound applications, including echocardiography and Doppler imaging of macrovascular and microvascular structures. It forms part of ROVI’s hospital and diagnostic imaging business.

• X-ray and computed tomography contrast agents

  Iomeron and Iopamiro

  Iomeron and Iopamiro are contrast agents marketed by ROVI under license from Bracco for computed tomography, X-ray, vascular radiology and hemodynamic procedures. They are part of the company’s hospital-products portfolio.

• Catheter-care hospital product

  Fibrilin

  Fibrilin is a sodium-heparin product used in the care and maintenance of venous access devices and catheters. It is a ROVI proprietary hospital product within the company’s catheter-care and hospital portfolio.

• Contract development and manufacturing

  ROVI Pharma Industrial Services

  ROVI Pharma Industrial Services is ROVI’s wholly owned CDMO platform. It provides sterile fill-and-finish services for prefilled syringes, vials and other injectable formats, together with inspection, labeling, packaging and related manufacturing capabilities. The platform serves pharmaceutical and biotechnology companies developing vaccines, biologics, biosimilars and other complex products.

• 2021

  Moderna vaccine particulate contamination and recall in Japan

  In August 2021, Japan suspended use of three lots of Moderna’s COVID-19 vaccine after foreign particulate matter was observed in unused vials. The affected vaccine had undergone fill-and-finish operations at ROVI’s Spanish facility. ROVI investigated the incident with Moderna, Takeda and health authorities. The investigation identified a manufacturing-line problem involving friction between metal components in a capping module. The lots were voluntarily recalled as a precaution, and the investigation did not establish that the reported deaths of two recipients were caused by the vaccine.

  Source

Read more

• 2024

  Further expansion of prefilled-syringe CDMO servicesStrategy

  Background

  ROVI sought to diversify CDMO revenues and use expanded sterile manufacturing capacity beyond COVID-19 vaccine production.

  Action taken

  ROVI Pharma Industrial Services signed an agreement to support manufacture of prefilled syringes for an unnamed global pharmaceutical company.

  Aftermath

  The agreement reinforced ROVI’s focus on high-value sterile injectables, prefilled syringes and long-term manufacturing relationships.

  Source

• 2022

  Ten-year extension of Moderna manufacturing agreementStrategy

  Background

  ROVI and Moderna had established a manufacturing relationship during the COVID-19 vaccine rollout and identified future demand for mRNA medicines.

  Action taken

  The companies signed a long-term agreement covering investment and expanded compounding, aseptic filling, inspection, labeling and packaging capacity in Spain.

  Aftermath

  ROVI strengthened its position as a CDMO for mRNA products and gained the possibility of supporting future Moderna vaccine candidates and medicines.

  Source

• 2022

  Launch of Okedi and commercialization of the ISM platformProduct launch

  Background

  ROVI had developed a proprietary long-acting injectable platform intended to reduce dosing frequency and improve sustained drug delivery.

  Action taken

  Following European authorization, ROVI launched risperidone ISM under the Okedi brand in selected European markets.

  Aftermath

  Okedi became ROVI’s first marketed product based on ISM and the principal vehicle for international commercialization of the platform.

  Source

• 2021

  Expansion from fill-and-finish into Moderna drug-substance manufacturingGeneration change

  Background

  ROVI’s initial Moderna role focused on finished-product operations, while the company sought deeper vertical integration and higher manufacturing capacity.

  Action taken

  ROVI announced investment in a new Granada production line to support manufacture of the active substance of Moderna’s mRNA vaccine.

  Aftermath

  The move broadened ROVI’s role in the vaccine supply chain and supported later regulatory approvals for active-substance manufacturing.

  Source

• 2020

  Entry into large-scale mRNA vaccine manufacturingStrategy

  Background

  The COVID-19 pandemic created urgent demand for global vaccine manufacturing, including European fill-and-finish capacity.

  Action taken

  ROVI agreed with Moderna to manufacture and perform fill-and-finish activities for Moderna’s COVID-19 vaccine for markets outside the United States.

  Aftermath

  The agreement materially increased ROVI’s visibility as a European CDMO and led to further investment in Spanish manufacturing facilities.

  Source

• 2015

  Expansion of injectable manufacturing capacityStrategy

  Background

  ROVI sought to strengthen its manufacturing base and increase its ability to serve the injectable pharmaceutical market.

  Action taken

  ROVI acquired an injectable manufacturing facility in San Sebastián de los Reyes and entered a strategic urology agreement with Astellas.

  Aftermath

  The additional facility later became part of the manufacturing network used for complex injectable products and Moderna’s COVID-19 vaccine.

  Source

• 2007

  Public listing on the Spanish stock marketStrategy

  Background

  ROVI had expanded beyond domestic pharmaceutical commercialization into proprietary medicines, international distribution and manufacturing infrastructure.

  Action taken

  The company completed its initial public offering and began trading under the ticker ROVI.

  Aftermath

  The listing provided a public capital-market platform while the López-Belmonte family retained control through Norbel Inversiones.

  Source

1. 1ROVI corporate historyrovi.es
2. 2ROVI productsrovi.es
3. 3ROVI prescription productsrovi.es
4. 4ROVI hospital productsrovi.es
5. 5ROVI strategyrovi.es
6. 6ROVI research and developmentrovi.es
7. 7ROVI corporate governance compositionrovi.es
8. 8ROVI annual financial report 2024rovi.es
9. 9ROVI and Moderna fill-and-finish collaborationrovi.es
10. 10ROVI completes first Moderna vaccine batchesrovi.es
11. 11ROVI and Moderna ten-year manufacturing agreementrovi.es
12. 12ROVI prefilled-syringe manufacturing agreementrovi.es
13. 13ROVI statement on Moderna vaccine particulate investigationrovi.es
14. 14Laboratorios Rovi Wikipedia articlees.wikipedia.org
15. 15Injectable facility receives FDA certificationrovi.es
16. 16Enoxaparin biosimilar receives European authorizationrovi.es
17. 17Juan López-Belmonte Encina becomes chairmanrovi.es
18. 18Okedi receives European authorizationrovi.es
19. 19U.S. FDA approves ROVI facilities for Moderna syringe fill-and-finishrovi.es
20. 20Expansion from fill-and-finish into Moderna drug-substance manufacturingrovi.es