What Onko does

Onko İlaç San. ve Tic. A.Ş. is a privately-held Turkish pharmaceutical manufacturer founded in 1987 by İrfan Koç with 100% domestic capital and headquartered in Gebze, Kocaeli. The company specializes in high-potency and oncology pharmaceuticals, operating two GMP-certified production facilities (EU GMP, Canada GMP, MHRA, Turkish GMP) covering 30,000 m² with capacity for 18M vials, 24M pre-filled syringes, 36M lyophilized vials, 240M tablets, and 35M capsules annually. Its therapeutic portfolio spans oncology, hematology, radiology, rheumatology, urology, neurology, immunology, dermatology, and organ transplantation across 10 treatment areas, with named products such as Bemustu (Bendamustine), Cytu (Cytarabine), Azatu (Azacitidine), and Byretu (Abiraterone).

The company's core technology platform centers on isolator-based manufacturing with OEL 4/5 containment for high-potency active pharmaceutical ingredients — a capability held by only ~14 facilities globally. Its Ministry of Science, Industry and Technology-certified R&D Center (the first and only GMP-licensed oncology R&D center in Turkey, est. 2015) develops generic, super-generic, and biosimilar formulations using Quality by Design (QbD) and Design of Experiments (DoE) methodologies aligned with EMA, USFDA, and ICH guidelines. The R&D facility spans 1,000 m² with 200+ advanced equipment units and is staffed by 50+ specialists with academic partnerships at leading Turkish universities and TÜBİTAK collaborations. Operations are supported by a SAP ERP system covering MM, WM, PP, PM, CO-PA, CO, FI, SD, QM, and HR modules, plus cloud-integrated HVAC monitoring across approximately 14,000 data points.

Onko monetizes its capabilities through four revenue streams: (1) direct sales of licensed products to Turkish hospitals, oncology centers, and pharmacies via a domestic sales force; (2) direct exports to 100+ countries across Europe, Africa, Middle East, and Asia; (3) contract manufacturing services (Fason Üretim) for international partners; and (4) out-licensing of in-house developed products to 70+ international strategic partners. The company also engages in in-licensing and technology transfer for portfolio expansion. Pricing in the Turkish domestic market is regulatory-controlled by government mechanisms, while international pricing follows jurisdiction-specific procurement and licensing terms. Strategic positioning emphasizes import displacement (96% of Turkey's oncology drugs were previously imported), vertical integration from R&D to commercial manufacturing, and export-led international growth, with 450+ cumulative global product registrations and 150+ ongoing licensing processes.

Name

Onko

Legal name

Onko İlaç San. ve Tic. A.Ş.

Website

https://onkokocsel.com

Company type

Private

Founded year

1987

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Onko İlaç San. ve Tic. A.Ş. is a privately-held Turkish pharmaceutical manufacturer specializing in oncology and high-potency drugs, operating EU/MHRA/Canada GMP-certified facilities in Gebze and exporting to 100+ countries through direct sales, contract manufacturing, and out-licensing.

Ownership category

akta.pro rank

Product category

Pharmaceutical Manufacturing (Oncology & Specialty)

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Oncology Specialty Pharmaceuticals (HLAIACAA)

akta.pro secondary industries

GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL), Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

Keywords

• Oncology pharmaceuticals
• Sterile injectable manufacturing
• High-potency drug production
• Contract pharmaceutical manufacturing
• Generic biosimilar development

Headquarters

HQ city

Gebze

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales (Domestic): Sale of licensed pharmaceutical products across oncology, hematology, radiology, rheumatology, urology, neurology, immunology, dermatology and transplant therapeutic areas in the Turkish domestic market through direct sales force.
2. International Exports: Export of high value-added pharmaceutical products to Europe, Africa, Middle East and other international markets. Revenue growth driven by geographic expansion to UK, Germany, Scandinavian-Baltic markets, Pakistan, Romania and other countries.
3. Contract Manufacturing (Fason Üretim): Third-party manufacturing services for local and international pharmaceutical companies using EU GMP, Canada GMP and MHRA-certified production lines. Includes manufacturing for European Union, Canada and United Kingdom markets.
4. Out-licensing: Licensing of products developed in R&D center to international partners for marketing and distribution in global markets.
5. In-licensing and Technology Transfer: Acquiring licenses for products and transferring innovative technologies to local facilities for local manufacturing, expanding product portfolio and enabling faster access to new treatments.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

Onko develops, manufactures, and commercializes high-potency and conventional pharmaceutical products — primarily oncology, hematology, immunology, and transplant medicines — in sterile liquid, sterile lyophilized, and solid oral dosage forms. It also provides contract manufacturing (fason), out-licensing, and in-licensing/technology transfer services to local and international pharmaceutical partners using its EU GMP-, Canada GMP-, and MHRA-certified facilities.

Product overview

Onko is a Turkish pharmaceutical company manufacturing high-potency and conventional medicines across two GMP-certified production facilities (30,000 m² total manufacturing area) in Gebze, Kocaeli, Turkey. Its portfolio spans sterile liquid (vials, pre-filled syringes), sterile lyophilized powder, and solid oral (film-coated tablets, capsules) dosage forms. The company operates a Ministry of Industry and Technology-approved R&D Center with over 200 state-of-the-art equipment units and 50+ R&D staff, developing generic, super-generic, and biosimilar drugs. With 450+ global licenses and operations across 100+ countries, Onko's product portfolio covers 10 therapeutic areas including Oncology, Hematology, Radiology, Rheumatology, Urology, Neurology, Immunology, Dermatology, Transplantation, and Physical Therapy & Rehabilitation. Named product brands include 5-Frotu (5-Fluorouracil injection), Aristu (Anastrozole), Azatu (Azacitidine), Bemustu (Bendamustine), Bleomitu (Bleomycin), Borea (Megestrol Acetate), Busultu (Busulfan), Byretu (Abiraterone Acetate), Carplatu (Carboplatin), Casomid (Bicalutamide), Celptu (Mycophenolate Mofetil), Cipintu (Cisplatin), Cytu (Cytarabine), Desitu (Decitabine), and Alfutu (Alfuzosin), among approximately 25 products listed on the first page of the product catalog. The company also provides contract manufacturing services (out-licensing, in-licensing, technology transfer) through its EU GMP, Canadian GMP, and MHRA-certified facilities.

Differentiator

Problem solved

Functional benefit

Products and services

• 5-Frotu (5-Fluorouracil Injection) Antineoplastic 5-Fluorouracil injection solution available in 500 mg/10 ml, 1000 mg/20 ml, and 5000 mg/100 ml doses, used in oncology treatment and supplied to hospitals and oncology centers.
• Alfutu (Alfuzosin Hydrochloride) Alfuzosin Hydrochloride prolonged-release 10 mg tablet for the treatment of Benign Prostatic Hyperplasia (BPH) and Acute Urinary Retention.
• Aristu (Anastrozole) Anastrozole 1 mg antineoplastic tablet used in the treatment of breast cancer.
• Azatu (Azacitidine) Azacitidine 100 mg powder for suspension for injection, an antineoplastic agent used in myelodysplastic syndromes and leukemia.
• Bemustu (Bendamustine Hydrochloride) Bendamustine Hydrochloride 100 mg concentrate for infusion solution, an antineoplastic agent for hematologic and oncologic indications.
• Bleomitu (Bleomycin Sulfate) Bleomycin Sulfate 15 mg lyophilized powder for solution for injection, an antineoplastic agent.
• Borea (Megestrol Acetate) Megestrol Acetate 160 mg tablet, an antineoplastic agent used in breast cancer treatment and appetite stimulation.
• Busultu (Busulfan) Busulfan 6 mg/ml concentrate for infusion solution, an antineoplastic agent used in hematopoietic stem cell transplantation.
• Byretu (Abiraterone Acetate) Abiraterone Acetate 250 mg hormone antagonist tablet used in the treatment of metastatic castration-resistant prostate cancer.
• Carplatu (Carboplatin Injection) Carboplatin solution for injection in 50 mg/5 ml, 150 mg/15 ml, and 450 mg/45 ml doses, a platinum-based antineoplastic chemotherapy agent.
• Casomid (Bicalutamide) Bicalutamide 50 mg antineoplastic tablet used in the treatment of prostate cancer.
• Celptu (Mycophenolate Mofetil) Mycophenolate Mofetil 250 mg and 500 mg tablets with dual indication as an antineoplastic selective immunosuppressant, used in organ transplantation and oncology.
• Cipintu (Cisplatin Injection) Cisplatin concentrate for infusion solution in 10 mg/10 ml, 25 mg/25 ml, 50 mg/50 ml, and 100 mg/100 ml doses, a platinum-based antineoplastic chemotherapy agent.
• Cytu (Cytarabine Injection) Cytarabine solution for injection in 100 mg/ml, 500 mg/5 ml, and 1000 mg/10 ml doses, an antineoplastic agent used in the treatment of leukemia and lymphoma.
• Desitu (Decitabine) Decitabine 50 mg powder for concentrate for infusion solution, an antineoplastic agent used in myelodysplastic syndromes.
• Contract (Fason) Pharmaceutical Manufacturing Third-party contract manufacturing of sterile liquid, lyophilized, and solid oral dosage forms for local and international pharmaceutical companies using EU GMP-, Canada GMP-, and MHRA-certified production lines. Services include manufacturing for the European Union, Canada, and United Kingdom markets.
• Out-licensing of R&D-Developed Products Licensing of products developed in Onko's R&D center to international pharmaceutical partners for marketing and distribution in global markets.
• In-licensing and Technology Transfer Acquisition of licenses for external products and transfer of innovative technologies to Onko's local manufacturing facilities, expanding the product portfolio and enabling faster access to new treatments.

Quantifiable outcome

• Producing products that previously had to be imported (96% of oncology drugs were imported before localization efforts)
• +2 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators18 records

Recent moves8 records

Expansion highlights7 records

Broad incumbents

• Viatris: Global generics and specialty pharma formed from Mylan-Upjohn merger, with a significant oncology and hospital injectable portfolio. Comparable to Onko as a generic injectable oncology competitor serving similar hospital and tender channels worldwide.
• Sandoz (Novartis): Global generic and biosimilar pharmaceutical company with strong presence in sterile injectables and oncology. Comparable to Onko as a generics manufacturer targeting hospital channels with injectable oncology and biosimilar products, though Sandoz operates at significantly broader scale.
• Teva Pharmaceutical Industries: Global generics leader with a large oncology injectable portfolio. Comparable to Onko as a generic and specialty pharmaceutical manufacturer competing in similar oncology molecules across multiple geographies, though at vastly greater scale and with innovator/integrated capabilities Onko lacks.

Direct peers

• Aspen Pharmacare: South African-headquartered specialty pharmaceutical company focused on generics, oncology and sterile injectables across emerging markets. Comparable to Onko as an emerging-market oncology generics manufacturer leveraging regional manufacturing hubs to supply Africa, Middle East and Asia with similar product types.
• Cipla: Indian-headquartered global pharmaceutical company with deep oncology and respiratory portfolios and emerging market strength. Comparable to Onko as an oncology-focused generic manufacturer with strong presence in Africa, Middle East and other emerging markets that overlap with Onko's export footprint.
• Dr. Reddy's Laboratories: Indian multinational with strong sterile injectables, biosimilars and emerging market operations. Comparable to Onko as a manufacturer of generic oncology injectables targeting regulated and semi-regulated markets, with overlapping therapeutic areas and channel profiles.
• Hikma Pharmaceuticals: Jordan-headquartered specialty pharmaceutical company with strong sterile injectable and oncology generics franchise across Middle East and US. Comparable to Onko as a regional injectable generics specialist targeting hospital channels in overlapping geographies (Middle East, emerging markets) with EU-GMP-style quality positioning.
• Polpharma: Polish-headquartered generics and CMO manufacturer with significant sterile injectable capacity and EU-GMP certifications. Comparable to Onko as a European-region generic and contract manufacturer of injectables serving regulated markets, with similar product portfolio and CMO business model.

Regional players

• Abdi İbrahim: Largest Turkish pharmaceutical company, focused on generics and branded products across multiple therapeutic areas. Comparable to Onko as a Turkish-domestic pharma peer competing in the same domestic market, distribution channels and regulatory environment, though with broader therapeutic and geographic focus.
• Eczacıbaşı İlaç: Turkish pharmaceutical manufacturer with branded generics, OTC and consumer health portfolio. Comparable to Onko as a domestic Turkish pharma competitor in overlapping therapeutic areas (urology, oncology adjacencies) with similar distribution and channel dynamics in the local market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@onkokocsel
• Xx.com/onkokocsel
• Facebookfacebook.com/onkokocsel

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 Onko