Oncology CDMOs

Oakwood Laboratories LLC is a US-based specialty pharmaceutical company and CDMO focused on advanced injectable drug delivery systems, particularly sustained-release and microsphere formulations. The company operates a GMP aseptic manufacturing facility in Solon, Ohio, providing contract development and manufacturing for long-acting injectable products.

Olpha (formerly Olainfarm JSC) is the leading pharmaceutical manufacturer in Latvia with over 50 years of experience and approximately 850 employees. The company produces finished dosage forms, active pharmaceutical ingredients, and intermediates across 10 therapeutic groups with a portfolio of more than 60 drug forms and 25 APIs. Olpha offers contract manufacturing and pharmaceutical co-development services, and exports to more than 60 markets. The company recently rebranded and aims to become a European top 10 pharmaceutical company.

Oncotec Pharma Produktion GmbH is a German CDMO specializing in the development and aseptic manufacturing of cytostatic (anticancer) drugs. Founded in 1997, the company provides full-service contract manufacturing from lab-scale development through commercial production, with approximately 2,300 m2 of cleanroom space and isolator-protected production lines at its Dessau-Rosslau facility.

Onko Ilac Sanayi ve Ticaret A.S. is a Turkish pharmaceutical company offering contract manufacturing and out-licensing services. The company manufactures finished dosage form pharmaceutical products including oncology drugs (fingolimod, pemetrexed, temozolomide, abiraterone) and other therapeutic areas, exhibiting regularly at CPHI events.

Pace Life Sciences is a division of Pace Analytical Services LLC, operating as a full-service CDMO/CRO network across the United States. The company supports drug development across the entire lifecycle from preclinical research through commercialization, specializing in small molecules, biologics (proteins, peptides, monoclonal antibodies, ADCs), nucleic acids (oligonucleotides, mRNA, plasmid DNA), and gene therapies. Recognized by PharmaSource as a Top CDMO in the United States. Operates 9+ strategically located sites including a sterile fill-finish Center of Excellence in Salem, NH.

Parexel International (MA) Corporation

Argentina

Parexel is a global contract research organization (CRO) providing clinical trial management, regulatory consulting, and biopharmaceutical development services. With over 24,000 professionals and 50+ clinical sites across five continents, the company offers Phase I-IV clinical trial services, CMC regulatory strategy, and real-world evidence generation. Parexel is primarily a CRO, not a drug manufacturer.

PharmIdea is a Latvian CDMO located in Olaine, Latvia, specializing in sterile drug development, commercial production, and worldwide supply of pharmaceutical products. The company focuses on sterile drugs in vials, offering contract manufacturing services including product development. PharmIdea has completed CTDs for out-licensing and provides contract manufacturing of sterile injectables such as Levosimendan concentrate for solution for infusion (small batch), Caspofungin, and Carbetocin. The company has partnered with Lidds for manufacturing NZ-TLR9 formulation against solid tumors.

Piramal Pharma Solutions (PPS) is a global CDMO under Piramal Pharma Limited, offering end-to-end development and manufacturing solutions across the drug lifecycle. Operates through a globally integrated network of 17 development and manufacturing facilities across North America, Europe, and Asia, with distribution in 100+ countries. Services include drug discovery, process/pharmaceutical development, clinical trial supplies, and commercial supply of APIs and finished dosage forms. Specialized in highly potent APIs, antibody-drug conjugations, sterile fill/finish, and peptide products. Multiple CDMO Leadership Award winner.

Reliance Life Sciences (RLS), part of Reliance Industries, is a premier Indian biotechnology company providing contract manufacturing and development services across pharmaceuticals and biosimilars. They have FDA-registered manufacturing facilities with 7 FDA-approved products (injectables, powders, tablets). Their capabilities span API manufacturing, formulation development, biologics/biosimilar manufacturing, and cell and gene therapy R&D. They are a vertically integrated biotech company with 1,000-5,000 employees, offering CDMO services alongside their own product portfolio.

SEDICO Pharmaceutical Company is an Egypt-based pharmaceutical manufacturer and API producer, providing contract manufacturing (CMO/CDMO) services. The company manufactures a broad range of pharmaceutical products including oral solids, injectables, and various dosage forms. SEDICO has recently entered oncology drug production through a partnership with Sandoz Global to localize oncology pharmaceutical products in Egypt.

STA Pharmaceutical Co., Ltd. (WuXi STA) is a subsidiary of WuXi AppTec and one of the world's leading CDMOs, specializing in integrated CMC services for small molecule APIs and drug products (oral and injectable/sterile) from preclinical to commercial scale. They also have capabilities in oligonucleotides, peptides, and bioconjugates. WuXi STA operates 9-14 global manufacturing sites across Asia, North America, and Europe with uniform quality/EHS standards approved by major regulators. They have supported 50+ first-time drug approvals since 2017 across 105 countries. The company has 5,100+ scientists, claims 100% PPQ success rate, and serves 1,200+ customers. Their Changzhou site has passed US FDA inspection and they have a continuous manufacturing line for oral solid dose.

Stason Pharmaceuticals, Inc. is a US-based pharmaceutical company headquartered in Irvine, California, with CDMO services provided through its affiliate Western PharmSci. The company operates in both branded/generic pharmaceuticals and contract services. Their CDMO capabilities include turn-key drug development and manufacturing for oral solid dosage forms with particular expertise in high containment products (OEL down to 0.1 ug/m3) for oncology, CNS, and other potent compounds. Services span from pre-formulation characterization and API synthesis through commercial production (up to 600 kg), including analytical method development/validation, formulation development, clinical trial materials, and serialization. They hold 30+ ANDAs and have operations in 13 locations across 9 countries. Note: FDA issued a warning letter on July 8, 2020, citing significant CGMP violations for finished pharmaceuticals.

Sterling Italy (Sterling S.p.A.) is a long-established Italian manufacturer specializing in the development, optimization, and manufacturing of steroidal APIs including corticosteroids, hormones, anabolics, estrogens, and progestinics. The company operates GMP production plants in Perugia, Italy and exports APIs to over five continents.

ST Pharm is a South Korean global API CDMO company founded in 1983, specializing in small molecule APIs, oligonucleotide therapeutics (ASO, siRNA, aptamers), and mRNA-LNP manufacturing. The company operates cGMP manufacturing facilities in South Korea and has a CRO subsidiary (AnaPath) in Switzerland and Spain for preclinical pathology services.

Sunny Pharmtech Inc. is a Taiwan-headquartered integrated specialty pharmaceutical CDMO specializing in high-potency APIs and drugs, including small molecules, peptides, and ADC linker-payloads. The company develops complex, high-barrier, niche drugs including ANDAs and 505(b)(2) filings, with state-of-the-art facilities offering OEB 5 containment and capabilities from early-stage formulation development to commercial manufacturing.

Division of Terumo Corporation (TSE:4543), a global healthcare technology leader since 1921 with 30,000+ employees. Provides sterile injectable contract development and manufacturing (CDMO) services from combination device design and formulation development to commercial manufacturing. Offers a portfolio of injection, infusion, and primary packaging solutions including PLAJEX polymer pre-fillable syringes, Immucise intradermal injection systems, hypodermic needles, and Surflo winged infusion sets. Recently expanded CDMO services outside Japan for global market and is doubling capacity.

Chinese pharmaceutical manufacturer specializing in corticosteroid, hormone, and steroid API production. Subsidiary of Shanghai Pharmaceuticals (Shanghai Xinyi Pharmaceutical Factory). Founded in 1992, located in Tianjin with approximately 170,000 sq meters across two factory areas and 507 employees. Main products include hydrocortisone, spironolactone, hydrocortisone acetate, clobetasol propionate, and related corticosteroid APIs. Also produces tablet formulations (9 approved products). Has 11 API production licenses and 9 tablet production licenses. FDA-registered with 3 FEI numbers, 13 inspections (4 NAI, 8 VAI, 1 OAI), and 2 FDA-approved finished dosage form products.

TOT BIOPHARM is a China-based biopharmaceutical CDMO headquartered in Suzhou Industrial Park, providing end-to-end CDMO services with established technology platforms focused on biologics and ADC manufacturing. The company operates a large-scale GMP-compliant commercial production base with 20,000L monoclonal antibody drug substance capacity, and has achieved PMDA (Japan) accreditation. Listed on HKEX (1875.HK).

Duplicate entry for VGXI Inc (see companyId 58cac364). Same company -- leading plasmid DNA CDMO in Texas. Same website URL (vgxii.com). Same capabilities, facilities, and services.

Vibalogics is a specialized global CDMO for virotherapy manufacturing, now operating as Recipharm Advanced Bio after acquisition by Recipharm AB. The company offers process and analytical development, GMP manufacturing of viral vectors, oncolytic viruses, and advanced therapies. Capabilities include xRNA therapies, viral vectors (AAV, lentivirus), microbial/live biotherapeutic products, recombinant proteins, plasmid DNA, and lipid nanoparticles. Major $50M expansion of Cuxhaven facility (500L manufacturing line) completed. 118,000 sq ft GMP facility in Massachusetts (US) also completed.

Zhejiang Davi Pharmaceutical Co., Ltd., established in 2004, is an exclusively foreign-owned high-tech manufacturer of active pharmaceutical ingredients and intermediates located in Huzhou City, Zhejiang, China. With a total investment of $8M USD and 35,000 m2 floor space, they operate FDA and COS-required GMP workshops. They specialize in folate-related APIs: Methotrexate, Methotrexate Sodium, Calcium Folinate (Leucovorin Calcium), Calcium Levofolinate, and L-5-Methyltetrahydrofolate Calcium. The company is FDA-registered with 3 FEI numbers, has 8 FDA inspections (2 NAI, 6 VAI, 0 OAI), 1 Class II recall, 4 FDA-approved products (tablet, extended-release tablet), and participates at CPHI events globally. They undertake OEM orders for intermediates. Classified as API manufacturer rather than CDMO because they primarily manufacture their own specialty APIs; contract services appear limited to OEM intermediate orders.

CHA Biotech is a South Korean biotechnology company within the CHA Hospital Group, established in 2002 with over 20 years of expertise in stem cell research and cell and gene therapy. The company operates a global CGT CDMO network through its US subsidiary Matica BioLabs, with GMP facilities in Korea (CHA Bundang Medical Center, Pangyo Techno Valley) and the US (Texas). CHA Biotech offers viral vector production (500L capacity for clinical trials) and has secured multiple CDMO contracts for CAR-T and organoid therapies.

Chongqing Huapont Shengchem Pharmaceutical Co., Ltd., founded in 1994, is a subsidiary of listed company Huapont Life Sciences. The company provides integrated R&D, production, and CDMO services for APIs and intermediates with 30+ years of experience, 700m3 reaction volume, 100+ R&D products, and registrations across US, EU, Japan, Korea, and China.

Chongqing Sintaho Pharmaceutical Co., Ltd. is a CDMO with 1 FDA-registered factory and 2 R&D centers, specializing in high-potency small molecules and XDC (antibody-drug conjugate linker-payloads). The company provides drug substance CDMO/CRO services with expertise in API and XDC development showcased at major industry events.

etherna (including its manufacturing arm etherna manufacturing) is a Belgian mRNA technology platform company that designs and manufactures research-grade and GMP-grade mRNA. The company provides custom drug delivery and mRNA manufacturing services, supporting partners from concept through clinical development.

Formosa Laboratories is a Taiwan-based CDMO specializing in custom synthesis and contract manufacturing of active pharmaceutical ingredients (APIs) for the global pharmaceutical industry. The company provides services from process development through commercial-scale API manufacturing, with FDA-registered facilities.

Fuji Chemical Industries Co., Ltd. is a Japanese pharmaceutical company specializing in API synthesis, spray drying contract manufacturing, drug product manufacturing, and excipient production. Founded in 1946 in Toyama, the company has been an FDA-inspected API manufacturer since 1981, and holds proprietary spray drying technology as well as excipient brands including Neusilin, Fujicalin, and F-melt.

FUJIFILM Biotechnologies (formerly FUJIFILM Diosynth Biotechnologies) is a global biologics CDMO operating 10 facilities across the US, UK, Denmark, and Japan with over 4,800 employees. The company provides end-to-end cGMP manufacturing services for biologics, advanced therapies, and vaccines, from preclinical through commercialization, with $8.6 billion invested in recent years and 20+ commercial licenses.

Genezen Labs (India) is the Indian entity of Genezen, a cell and gene therapy CDMO specializing in viral vector manufacturing services. The company provides lentiviral, retroviral, and adeno-associated viral (AAV) vector CDMO services, along with cell therapy manufacturing and plasmid design. Genezen operates a 60,000 sq ft cGMP facility in Fishers, Indiana and an 86,000 sq ft licensed viral vector manufacturing facility in Lexington, Massachusetts.

Goodwin Biotechnology (GBI) is a full-service biopharmaceutical CDMO based in Florida, specializing in biologics development and manufacturing. Named Manufacturer of the Year by BioFlorida, GBI offers its Single-Source Solution for monoclonal antibodies, ADCs, recombinant proteins, and other complex biologics from cell line development through cGMP commercial manufacturing. The company provides mammalian cell culture manufacturing using CHO and other expression systems.

Hangzhou FST Pharmaceutical Co., Ltd., established in 2001, is a Chinese national high-tech enterprise primarily engaged in the R&D and production of APIs and pharmaceutical intermediates. The company focuses on antitumor (tinib series), cardiovascular, antihistamine, antipsychotic, and antiviral product lines, selling to South Korea, the Middle East, Europe, the United States and other regions.

Hubei Biocause Heilen Pharmaceutical Co., Ltd. is a Chinese pharmaceutical company based in Jingmen City, manufacturing active pharmaceutical ingredients including fludarabine phosphate, ibuprofen, and other APIs. The company is FDA-registered and has undergone multiple FDA inspections. It also offers contract manufacturing services.

I Peace Inc. is a Palo Alto, California-based biotech CDMO specializing in cGMP manufacturing of iPSC (induced pluripotent stem cells) and iPSC-derived cell products for cell and gene therapy development. The company provides custom GMP cell manufacturing, process development, cell banking (MCB/WCB), gene editing, differentiation services, and regulatory support compliant with FDA, PMDA, and EudraLex standards. I Peace has manufactured 100+ GMP iPS cell lines and tripled its CDMO facility capacity.

JSR Life Sciences (KBI Biopharma / Selexis)

Switzerland

JSR Life Sciences is the parent organization of KBI Biopharma (CDMO) and Crown Bioscience (CRO), plus Selexis (cell line development). KBI Biopharma is a biologics CDMO providing mammalian and microbial expression, process development, analytical development, and clinical through commercial GMP manufacturing. Crown Bioscience is a separate CRO arm focused on preclinical oncology. This entity spans CDMO and CRO, but the primary CDMO identity is through KBI Biopharma. FDA registered with 4 FEI numbers and 5 inspections (4 NAI, 1 VAI).

Jubilant Biosys Limited

India

Jubilant Biosys is a CRDMO (Contract Research, Development and Manufacturing Organization) under Jubilant Pharmova. Over 20 years experience, 2,400+ employees, five sites across India and Europe. Offers integrated drug discovery (IDD), chemistry services, biology services, and CDMO services including process R&D, analytical development, technology transfer, GLP/non-GMP/GMP manufacturing. Recently expanding into biologics and ADC discovery at European site. FDA registered with 3 FEI numbers, 14 inspections including 4 OAI -- regulatory risk flag. Note: Website claims biologics/ADC capability but this is at discovery stage only, not GMP manufacturing.

KareBay Biochem

China

KareBay Biochem (Monmouth Junction, NJ) is a custom synthesis and contract manufacturing company offering organic synthesis, peptide synthesis (including cGMP peptide synthesis), antibody production, protein expression, bioconjugation, oligonucleotide synthesis, RNA synthesis, polymer synthesis, and immunoassay services. Also sells catalog products (small molecule inhibitors, bioactive compounds, peptides, antibodies, amino acids, fluorescent dyes). Products are for research, laboratory and further evaluation purposes. cGMP peptide and organic synthesis services are explicitly offered.

KBI Biopharma

Switzerland

KBI Biopharma is a global biologics CDMO (part of JSR Life Sciences) providing mammalian and microbial-based biopharmaceutical development and manufacturing services. Offers cell line development (SUREtechnology Platform powered by Selexis for CHO, PUREplatform for E. coli), process development, analytical development, formulation development, characterization, clinical and commercial GMP manufacturing. FDA registered (FEI 3004638264) with ANALYSIS, API MANUFACTURE, and MANUFACTURE operations. Positioned as a 'next-generation CDMO' with standalone services portal for analytical testing.

KD Pharma Group

Germany

KD Pharma Group is a pure-play, technology-driven CDMO with unique expertise in lipids (omega-3 APIs from fish and algae) and specialized small molecule products. Offers vertically integrated services: API manufacturing (lipid-based and small molecule), finished dosage forms (softgels, liquid bottling, packaging). Pharma division (KD Pharma) provides pharmaceutical APIs and custom synthesis. Nutra division (KD Nutra) serves nutritional supplement companies. KD Biopharma runs Phase 3 clinical trials for lipid-based therapeutics (FAP, UC, COVID-19). Recently expanded manufacturing site in Seal Sands, UK. FDA registered with 2 FEI numbers, 3 inspections (3 VAI).

KriSan Biotech is a Taiwan-based CDMO founded in 2015, located in Tainan Science Park. They provide one-stop CDMO services for small molecule APIs, peptides, oligonucleotides, antibody-drug conjugates (ADC), and high-potency drugs from preclinical to commercialization. The company has a professional team averaging 10+ years of API experience. KriSan has partnered with CMIC BIO for ADC/XDC innovation, signed MoU with Mycenax for ADC capabilities, and has supplied kg-scale API to companies such as Atossa Genetics (NASDAQ: ATOS) and OncoArendi Therapeutics. They hold PIC/S GMP certification from TFDA.

Laboratorios Farmaceuticos ROVI S.A. is a major Spanish CDMO and pharmaceutical company, one of the leading European contract manufacturers for high-value-added injectable products. Their CDMO division (ROIS) operates three industrial complexes: two for injectables (Madrid and San Sebastian de los Reyes) and one for oral solid forms and packaging (Alcala de Henares). They also have two facilities in Granada for their own products (bemiparin and enoxaparin). ROVI's Madrid injectables plant is approved by EMA, FDA, and regulators in Korea, Brazil, and Gulf States, with ISO 9001, ISO 14001, and OSHAS certifications. They recently acquired a Bristol-Myers Squibb injectable drug product manufacturing site in Phoenix, Arizona for $250 million, expanding their capacity. ROVI provides end-to-end services from development to final product release, including clinical trials, stability studies, and analytical services. They have collaborated with Roche for manufacturing new medicines in development.

LOTTE BIOLOGICS

South Korea

LOTTE BIOLOGICS is a global biologics CDMO headquartered in South Korea, offering end-to-end development and cGMP manufacturing services for biological Drug Substance. Operates the Syracuse Bio Campus (New York, USA) with 40,000L capacity and the Songdo Bio Campus (Incheon, South Korea) planned for 120,000L by 2027. Also operates a $100M ADC manufacturing facility.

Mabion S.A.

Poland

Mabion S.A. is a Polish end-to-end biologics CDMO offering Drug Substance manufacturing, fill/finish, process development, cell line development and banking, and analytical services. Headquartered in central Poland (1.5 hours from Warsaw airport), they position themselves as a European CDMO partner for pharma and biotech companies. Their capabilities span the full biologics lifecycle from gene to vial.

MabPlex International

China

MabPlex International is a China-headquartered CDMO providing comprehensive biomanufacturing services for the global biopharmaceutical and biotechnology industry. They offer innovative CRO and CMO services for biologics, with facilities in China and the USA (MabPlex USA). They are expanding CDMO services and manufacturing capacity to meet global biologics demand, with multiple manufacturing sites.

mAbxience

Spain

mAbxience, a Fresenius entity, is a global CDMO with 14+ years of experience in the development and manufacture of biopharmaceuticals, specializing in biosimilars and monoclonal antibodies. They are FDA-registered with two FEI numbers for analysis and API manufacture. They have partnered with HP to develop AI solutions for optimizing monoclonal antibody and biosimilar production. Their CDMO platform offers tailored solutions with quality, agility, and flexibility in manufacturing.

Macleods Pharmaceuticals Ltd

India

Macleods Pharmaceuticals Ltd is one of India's top 10 pharmaceutical companies, operating as a CDMO for developing, manufacturing, and globally distributing pharmaceutical products. They produce diverse dosage forms including solid orals, liquid orals, topical formulations, injectables, metered dose inhalers, and dry powder inhalers across therapeutic areas including anti-TB, antimalarials, antiretrovirals, antidiabetics, antihypertensives, and antiasthmatics. They have 152 FDA-approved products, WHO prequalified medicines, and manufacturing facilities compliant with UK MHRA, US FDA, TGA, and WHO guidelines. They operate in 100+ countries.

National Resilience Inc.

Canada

Major North American biomanufacturing CDMO (branded as 'Resilience') focused on complex medicines including large molecule biologics, cell therapies, and aseptic drug product manufacturing. Operates facilities across the US and Canada. Delivers 100+ million vials and pre-filled syringes annually. Secured $825 million in financing to accelerate CDMO strategy. Offers proprietary technology platforms including Sprout Solutions, Auto-T, DAR-T (next-gen CAR-T), and Idea to Clinic services. FDA registered with 7 FEI numbers, 17 inspections.

Polymun Scientific Immunbiologische Forschung GmbH is an Austrian specialist CDMO in biopharmaceuticals and liposomal/lipid nanoparticle (LNP) formulations. Offers contract development and manufacturing from gene to clinical grade material for innovator and biosimilar products. Unique expertise in liposomal drug formulations that protect, transport, and release drugs at target sites. Also maintains R&D projects including liposomal superoxide dismutase, recombinant porcine trypsin, and HIV antibodies/antigens. FDA registered for analysis, API manufacture, and manufacture.

Prachi Pharmaceuticals Pvt Ltd, established in 1988, is an Indian GMP-certified manufacturer, supplier, importer, and exporter of Active Pharmaceutical Ingredients, iodine compounds, and specialty chemicals. Based in Mumbai, they have 26-50 employees with annual turnover of INR 25-100 Cr. Their product range includes iodine compounds, triphenyl methane, potassium metaperiodate, chlorhexidine digluconate, camphor quinone, closantel base, L-seleno methionine, and veterinary products. They are listed on PharmaSource and PharmaCompass as an API manufacturer with USDMF filings including furosemide.