What Kleva does

Kleva Pharmaceuticals S.A. is a privately held Greek pharmaceutical Contract Development and Manufacturing Organization (CDMO) founded in 1974 by George Th. Chronopoulos and headquartered in Acharnes, Greece, with a second manufacturing facility of 7,500 sq.m. in Polydendri. The company provides an integrated portfolio of pharmaceutical services spanning contract manufacturing across multiple dosage forms (tablets, capsules, sterile injectables, ophthalmics, semi-solids, liquids, nasal preparations, suppositories), research and development from initial formulation through CTD-format dossier compilation, technology transfer with gap analysis and scale-up, regulatory affairs support including marketing authorization lifecycle management, and pharmacovigilance. Kleva owns 190 marketing authorizations globally and exports 80 products across 30 countries in Europe, the Middle East, Asia, Africa, Australia, New Zealand, and CIS markets.

The company's revenue model is multi-stream: contract manufacturing fees for client products, professional services revenue for R&D, technology transfer, and regulatory affairs engagements, and licensing/dossier sales from its owned marketing authorizations (190 MAs globally). Production capacity exceeds 18 million boxes annually, including 300 million tablets, 25 million capsules, and 12 million sterile ampoules. The technology infrastructure includes two quality control laboratories (analytical and microbiological), advanced analytical instrumentation (HPLC, UV-VIS, FTIR, dissolution apparatus), an independent Tech Transfer Department, and a serialization/track-and-trace system compliant with FMD Global guidelines.

Kleva's go-to-market is B2B enterprise field sales combined with event-driven business development (e.g., CPHI Milan 2024) and direct outreach to pharmaceutical companies worldwide. The customer base consists of 50+ pharmaceutical company clients across 30 countries, served through distribution and licensing agreements, technology transfer, or co-development models. The company has shifted from a Greece-centric generic manufacturer to an export-oriented CDMO since 2012, and has secured recent regulatory milestones including MHRA approval for ophthalmic solutions (July 2025) and GMP certification for Plant B Polydendri (November 2024). Ownership remains concentrated within the founding Chronopoulos family across three generations, with no disclosed external institutional or private equity investors.

Name

Kleva

Legal name

KLEVA Pharmaceuticals S.A.

Website

https://kleva.gr

Company type

Private

Founded year

1974

Operating status

Operating

Headcount range

51–100 employees

Short description

Kleva Pharmaceuticals S.A. is a Greek pharmaceutical CDMO founded in 1974, providing contract manufacturing, R&D, regulatory affairs, and technology transfer services across multiple dosage forms for pharmaceutical companies in 30 countries. It owns 190 marketing authorizations and operates EU GMP- and MHRA-certified facilities.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing and Development (CDMO)

NAICS

Drugs and Druggists' Sundries Merchant Wholesalers (424210)

SIC

Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Contract pharmaceutical manufacturing
• Pharmaceutical product development
• Generic drug manufacturing
• Pharmaceutical technology transfer
• Regulatory affairs services

Headquarters

HQ city

Acharne

HQ country

Greece

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Supply Chain

Revenue model

1. Contract Manufacturing Services: Kleva manufactures pharmaceutical products on behalf of clients worldwide, providing production services across multiple dosage forms from its GMP-compliant facilities. Revenue is generated through manufacturing fees for client products.
2. Research & Development Services: R&D services for third parties including development of generic pharmaceutical products from initial stages to CTD-format dossier compilation. Services include patent search, API sourcing, formulation development, and regulatory dossier preparation.
3. Technology Transfer Services: Technology transfer services including review of registered product documentation, gap analysis, process transition between development and manufacturing sites, scale-up batch production, and stability testing.
4. Regulatory Affairs Services: Regulatory affairs services including marketing authorization lifecycle management, registration procedures (National, DCP, MRP), dossier compilation in CTD/eCTD format, and regulatory support for product approvals.
5. Product Licensing and Dossier Sales: Sale of marketing authorizations and dossiers, out-licensing activity providing upgraded CTD files aligned with European guidelines. The company owns 190 marketing authorizations globally.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Kleva is a pharmaceutical Contract Development and Manufacturing Organization (CDMO) providing end-to-end services from product development through commercial manufacturing. Its service portfolio includes contract manufacturing across multiple dosage forms (tablets, capsules, sterile injectables, ophthalmics, creams, ointments, liquids, suppositories, nasals), R&D and CTD-format dossier development, technology and analytical transfer, regulatory affairs, quality assurance, and pharmacovigilance. The company also owns 190 marketing authorizations globally and exports 80 products to regulated and non-regulated markets via licensing and distribution partnerships.

Product overview

Kleva Pharmaceuticals is a pharmaceutical contract development and manufacturing organization (CDMO) established in 1974, based in Athens, Greece. The company operates two manufacturing facilities and offers an integrated portfolio of products and services. Its core product offerings span multiple dosage forms including solid forms (tablets, capsules, granules), semi-solids (creams, ointments, gels), liquids (syrups, solutions), nasal preparations, parenterals (vials, ampules), suppositories, and ophthalmic products. Flagship product Ezipol (Omeprazole) represents their leading pharmaceutical formulation. The service portfolio includes contract manufacturing, R&D development services, regulatory affairs, technology transfer, quality assurance, pharmacovigilance, and international business development. With 190 marketing authorizations globally and operations across 30 countries, Kleva serves as a full-service pharmaceutical CDMO partner for clients in Europe, Asia, Africa, Oceania, and the Middle East.

Differentiator

Problem solved

Functional benefit

Brands

• Ezipol: A leading product (Omeprazole) distributed in the Greek pharmaceutical market through a partner distribution channel.

Products and services

• Contract Manufacturing Services Full-service pharmaceutical contract development and manufacturing (CDMO) for client products across solid, semi-solid, liquid, nasal, parenteral, suppository, and ophthalmic dosage forms, covering product development, manufacturing, packaging, and release for pharmaceutical, nutraceutical, food supplement, medical device, and health & beauty clients.
• R&D Development Services Complete generic pharmaceutical product development services from initial stages through CTD-format dossier compilation, including patent search, API sourcing, formulation development, pilot scale batches, and stability studies for third-party clients.
• Regulatory Affairs Services Comprehensive regulatory services including marketing authorization applications, dossier compilation in CTD/eCTD format, regulatory support for product approvals, renewals, and variations across EU and non-EU countries, including National, DCP, and MRP registration procedures.
• Technology Transfer Services Comprehensive technology transfer services including review of registered product documentation, gap analysis, process optimization between development and manufacturing sites, scale-up batch production, and stability testing.
• Quality Assurance Services Quality management services ensuring compliance with EU GMP, ISO 9001:2015, and international regulatory requirements, delivered through continuous monitoring, improvement programs, and trained scientific personnel.
• Pharmacovigilance Services Comprehensive pharmacovigilance system ensuring compliance with international, EU, and local legal requirements, including 24/7 adverse event reporting lines and a permanently available Qualified Person (QPPV).
• Business Development and Licensing Services International business development including market strategy, distribution agreements, licensing, dossier sales, and co-development partnerships for Kleva's 190 owned marketing authorizations across 30 countries.
• Ezipol (Omeprazole) Branded pharmaceutical product (Omeprazole) — Kleva's flagship proprietary formulation — distributed in the Greek pharmaceutical market through partner distribution channels for healthcare professionals and patients.

Quantifiable outcome

• 50+ customers across 30 countries served since 2012
• +4 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered minor, major and core.

• Afidnes Forest Protection Volunteer AssociationminorOthers · 1 January 2024Third consecutive year of symbolic financial contribution to volunteer fire prevention and civil protection association. The association operates 24-hour shifts during fire season for fire prevention, extreme weather response, and rescues.
• Ezipol Distribution Partner (Greece)minorChannel Partner/ Reseller/ Distributor · 27 December 2023New collaboration for distribution of Ezipol/Omeprazole product in the Greek pharmaceutical market. Ezipol is distributed through partner's distribution channel, making the product available to healthcare professionals and patients in Greece.
• Greek Red CrossminorOthers · 23 February 2023Humanitarian partnership for earthquake relief. Collected essential supplies for earthquake victims in Turkey and Syria, delivered to Red Cross facilities on February 23, 2023.
• National and Kapodistrian University of Athens - Pharmaceutical DepartmentminorOthers · 24 January 2023Donation of five fully integrated computer units to the Pharmaceutical Department of the Center of Continuing Education and Lifelong Learning at NKUA, in memory of founder George Chronopoulos.
• Actavis, Sandoz, Pliva, NycomedmajorStrategic or Co-development Partner · 1 January 2005Global pharmaceutical companies including Actavis, Sandoz, Pliva, and Nycomed partnered with Kleva through Business Development Department established in 2005 for export expansion.
• Vigi-CarecoreStrategic or Co-development PartnerPharmacovigilance partner providing 24/7 safety reporting line (Tel: +30 217 000 9002) and email ([email protected]) for adverse event reporting related to Kleva products.
• Creative Pharmaceutical ServicescoreStrategic or Co-development PartnerPharmacovigilance partner committed to complying with laws governing operation, maintaining good practices, and providing high-quality services. Contact: Tel: +30 210 3259365 (24h), [email protected].

Scale indicators10 records

Recent moves17 records

Expansion highlights5 records

Direct peers

• Delpharm: France-based CDMO with broad sterile, liquid, and solid-dose capabilities serving European generic and branded pharma. Comparable service breadth and customer overlap with Kleva.
• Aenova Group: German-headquartered CDMO offering solid, semi-solid, liquid, and sterile dosage forms for generics and branded pharma across Europe. Comparable to Kleva in business model (contract development + manufacturing + regulatory dossiers) and customer base (European generic pharma sponsors).
• Fareva: French pharmaceutical CDMO with development, manufacturing, and packaging services across multiple dosage forms. Operates as a multi-site EU alternative for generic and branded pharma sponsors similar to Kleva.
• Recipharm: Swedish CDMO specializing in solid dose, sterile fill-finish, and inhalation products for generics and innovators. Closely comparable multi-dosage-form EU CDMO serving a similar pharma client base.
• Hovione: Portuguese CDMO with integrated drug substance, drug product, and analytical services. Comparable full-service CDMO model though more oriented to complex/API work; competes for European tech-transfer and commercial manufacturing mandates.

Broad incumbents

• Catalent: Global, multi-modality CDMO with extensive sterile fill-finish, oral solid, and inhalation capacity. A much larger incumbent that competes with Kleva on European tech-transfer and commercial manufacturing contracts, particularly with innovator sponsors.
• Piramal Pharma Solutions: Global CDMO with sterile injectable and oral solid dose capacity including European sites. Competes with Kleva for European commercial manufacturing and tech-transfer programs for generic and specialty pharma.
• CordenPharma: European CDMO with capabilities across peptides, small molecules, injectables, and oral solids. Overlaps with Kleva in sterile and oral dosage forms for generic and branded pharma clients.
• Almac Group: Northern Ireland-headquartered CDMO offering API, formulation development, commercial manufacturing, and regulatory services. Comparable integrated CDMO model and target customer base across Europe and the US.

Regional players

• Sopharma: Bulgarian pharmaceutical manufacturer with generics, contract manufacturing, and dossier licensing activities in CEE and CIS. Comparable Eastern-European generics manufacturer with similar dossier/CMO business model.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Kleva