Cytotoxic & ADC Handling CDMOs

Hiral Labs Ltd

India

Hiral Labs Ltd is an Indian pharmaceutical contract manufacturer established in 2000, based near Roorkee, Uttarakhand. The company operates two WHO-GMP and ISO-certified manufacturing sites producing liquid injections, tablets, capsules, ointments, syrups, eye/ear drops, and oncology injections (including lyophilized). Hiral Labs manufactures over 350 formulations on a contractual basis for more than 300 companies across approximately 4,000 brands.

Axcellerate Pharma LLC

United States

Axcellerate Pharma LLC is an award-winning CDMO based in Piscataway, New Jersey, providing CRO and CDMO services for both large and small molecules. Their capabilities span cGMP API manufacturing (small molecules), sterile aseptic filling (vials, syringes, cartridges, bags), lyophilization, mammalian cell culture, microbial fermentation, oligonucleotide synthesis, PEGylation, and commercial manufacturing including generics, controlled substances, hormones/steroids, and cytotoxic/oncology compounds. The company operates from a multi-faceted facility that includes ISO Class 5-8 sterile areas, dedicated process areas for biologics development, chemical development, and sterile manufacturing.

BioTechnique LLC

United States

BioTechnique LLC is a full-service CRDMO based in York County, Pennsylvania, specializing in cytotoxic and therapeutic sterile injectable fill-finish services. The company provides services from investigational/clinical through to final marketed products, handling both small and large batch sizes. BioTechnique operates an FDA-registered facility with capabilities spanning sterile manufacturing, lyophilization, and high-potency compound handling.

Aspen API

Netherlands

Aspen API (part of Aspen Global) is a CDMO specializing in complex chemical API and peptide manufacturing. With multiple FDA- and EMA-inspected manufacturing sites, they offer end-to-end API development from process R&D to commercial-scale production, including high-potency API (HPAPI) manufacturing with containment capabilities. They are part of the larger Aspen CDMO network.

Aarti Pharmalabs Limited

India

Aarti Pharmalabs Limited is a leading Indian small-molecule CDMO specializing in API and drug substance development and manufacturing. They operate six manufacturing plants with two R&D centers, accredited by USFDA, EU GMP, EDQM, and KFDA. They provide services from process R&D through stability studies, scale-up, process validation, and commercial manufacturing, including high-potent/cytotoxic molecules and flow chemistry.

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.

ACIC Pharmaceuticals Inc

Canada

ACIC Pharmaceuticals Inc is a CDMO headquartered in Coral Springs, Florida, providing integrated pharmaceutical solutions from molecule to market. They offer API manufacturing, CDMO services for complex injectables including long-acting and cytotoxic injectables, regulatory support, and pharmaceutical equipment solutions. They have 249 FDA-approved products across a wide range of dosage forms.

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).

AbbVie Contract Manufacturing (AbbVie CMO)

Italy

AbbVie Contract Manufacturing is an embedded CMO within AbbVie, providing third-party contract manufacturing services for over 40 years across 12 locations in the US and Europe. They offer services spanning antibody drug conjugates, aseptic fill/finish, biologics (mAbs and derivatives), custom API, eye care, hot melt extrusion, HPAPI, and oral solid dose manufacturing.

Normon

Spain

Laboratorios Normon is a Spanish pharmaceutical company manufacturing generic medicines. Founded as a family company, it has invested over 100 million euros in expansion and operates FDA-registered manufacturing facilities. The company is listed as a CMO/CDMO on PharmaSource and appears in cytotoxic drugs and HPAPI manufacturing market reports, indicating high-potency capabilities.

CARBOGEN AMCIS

CHina

CARBOGEN AMCIS is a leading CDMO offering drug substance and drug product development and manufacturing services from early development through commercialization. Part of the Indian Dishman Carbogen Amcis group, the company has facilities in Switzerland, France, UK, Netherlands, and China, specializing in complex small molecule APIs, ADC payloads, and sterile drug products.

Cerbios‑Pharma SA

Switzerland

Cerbios-Pharma SA is a privately held Swiss CDMO based in Barbengo-Lugano with over 40 years in the pharmaceutical industry, now part of the HAS Group. The company specializes in the development and manufacture of chemical and biotechnological APIs, with particular expertise in HPAPIs (high-potency APIs), ADC payloads and conjugation, and recombinant proteins and antibodies. Cerbios offers both chemical synthesis and biological manufacturing capabilities, including living microorganism-based products.

Olon SpA is a global leader in the development and production of Active Pharmaceutical Ingredients (APIs) for CDMO and generic markets, integrating chemical synthesis and microbial biomanufacturing. The company operates 14 GMP facilities primarily in Italy, with additional sites in France (via GTP Bioways acquisition), the US, Germany, and China, with 450+ DMFs and 35+ years of regulatory experience.

Sever Pharma Solutions

France

Sever Pharma Solutions is a specialized CDMO focused on high-potent and cytotoxic drug products (up to OEB6), polymer-based controlled-release delivery systems (implants, vaginal rings), hot melt extrusion for bioavailability enhancement, and prefilled syringe/autoinjector aseptic fill-finish. With sites in Malmö (Sweden) and Putnam (Connecticut, USA), they offer end-to-end services from formulation development through commercial manufacturing.

PCI Pharma Services

Australia

PCI Pharma Services is a global CDMO providing fully integrated drug development, manufacturing, clinical trial services, and commercial packaging solutions. With over 8,000 employees in 38 GMP facilities worldwide, PCI offers services spanning sterile fill-finish, lyophilization, oral solid dose manufacturing, complex formulations, and advanced drug delivery including drug-device combination products.

Sterling Pharma Solutions

Ireland

Sterling Pharma Solutions is a global CDMO with over 50 years of experience providing API development and manufacturing services to pharmaceutical and biotech companies. The company specializes in high potency APIs, hazardous chemistry, controlled substances, peptides, flow chemistry, biocatalysis, and ADC bioconjugation across six facilities in the UK, Ireland, and US.

Bryllan

United States

Bryllan is a US-based CDMO specializing in the production and filling of potent and cytotoxic compounds, with a focus on aseptic powder and liquid filling for complex drug and device combination products. The company operates a high-containment, state-of-the-art facility in Brighton, Michigan, supporting both clinical and commercial supply of ADCs and other cytotoxic products.

CordenPharma is a full-service CDMO providing integrated development and manufacturing of APIs, drug products, and lipid excipients across a global network of cGMP facilities in Europe and North America. The company offers capabilities spanning peptides, oligonucleotides, highly potent and oncology compounds, small molecules, injectables, lipid nanoparticles (LNPs), and oral solid dosage forms. CordenPharma is investing over EUR 500M in a new peptide manufacturing facility in Muttenz, Switzerland, and expanding its Colorado site for large-scale peptide production.

Aton Biotech

China

Aton Biotech is a China-based biologics CDMO backed by Henlius Biotech, offering one-stop solutions from early development to commercial production. They provide services in process development, GMP manufacturing, analytical testing, and ADC development. With access to up to 144,000L bioreactor capacity from parent company Henlius, they focus on monoclonal antibodies, recombinant proteins, and antibody-drug conjugates.

Simtra BioPharma Solutions

Germany

Simtra BioPharma Solutions is a global CDMO focused exclusively on sterile injectable drug products. With over 65 years of expertise, Simtra offers formulation development, lyophilization cycle optimization, technology transfer, analytical services, fill/finish operations, specialized containment, and global regulatory support. They handle cytotoxics, highly potent compounds, biologics, vaccines, small molecules, ADCs, and diluents. They have a strategic alliance with MilliporeSigma for ADC manufacturing. The company has transferred 60+ ADC candidates including six commercial products to their German site.

Fermion, a wholly owned subsidiary of Orion Corporation (Finland), is a CDMO specializing in developing, manufacturing, and marketing small molecule Active Pharmaceutical Ingredients (APIs), including HPAPIs, cytotoxics, steroids, generics, and controlled substances. Together with its parent Orion, it offers integrated contract development and manufacturing services for both drug substances and drug products, covering the full lifecycle from preclinical to commercial scale. FDA-approved since 1979 and EMA-approved since 1971.

Abzena

United States

Abzena is a leading complex biologics and bioconjugates CDMO+CRO headquartered in the UK with 20+ years of experience. They provide fully integrated services from antibody discovery through commercial GMP manufacturing, specializing in ADCs, AOCs, RDCs, mAbs, fusion proteins, and bispecifics. With over 1,400 lead candidates discovered, 100+ production cell lines developed, and 2,000+ bioconjugates produced, they operate state-of-the-art facilities in San Diego, Bristol (PA), and Cambridge (UK).

Prasfarma

Spain

Prasfarma is a Spanish pharmaceutical company operating as a CMO and CDMO, headquartered in Cerdanyola del Valles (Barcelona) with a manufacturing plant in Manlleu (Barcelona). They are recognized as a reference in the sector for production of oncology (cytostatic) and high potency products. Their product range includes cytostatic oral forms (hard capsules, sachets, film coated and sugar coated tablets), non-cytostatic parenteral forms (vials, ampoules, prefilled syringes), and cytostatic parenteral forms (liquids, lyophilized). Services encompass development, co-development, regulatory affairs, clinical research, production, logistics, and marketing agreements. ISO 14001:2015 certified.

Indena

France

Indena is an Italian company with over 100 years of botanical and pharmaceutical expertise, headquartered in Milan. It provides CDMO services specializing in complex API manufacturing including semisynthesis, fermentation, and high-containment processing for HPAPIs with OEL as low as 1 ng/m3. Indena is AIFA-approved and FDA-registered, with particular focus on oncology-related ADC components and complex chemical synthesis.

NerPharMa srl (NMS Group)

Italy

NerPharMa is an Italian CDMO (part of NMS Group, acquired by Benta in 2026) specializing in highly potent compounds with strong expertise in oncology. It operates two divisions: Drug Substance (API manufacturing in high containment glove-box suites, 50-250L reactors, 0.5-5 kg batches) and Drug Product (injectable solutions, suspensions, lyophilized products, and oral solid dosage forms including cytotoxic and cytostatic products).

Bora Pharmaceutical

Canada

Bora Pharmaceuticals is a global CDMO headquartered in Canada with manufacturing facilities across North America and Asia. The company offers comprehensive contract development and manufacturing services for oral solid dosages, sterile injectables, topicals, and liquids, serving both clinical and commercial supply needs with FDA and EMA approved facilities.

Axplora

Germany

Axplora is a global CDMO specializing in API manufacturing, headquartered in Raubling near Munich, Germany. The group comprises Axplora, Novasep CDMO, and Farmabios, with over 2,000 employees across 10 manufacturing sites on three continents serving 900+ customers. Axplora has particular expertise in chromatography-based separations and small molecule manufacturing, with strong positions in oncology (ADC payloads via Novasep's Le Mans site) and GLP-1 receptor agonist manufacturing (EUR 50M investment at Mourenx, France). The company manufactures both specialty API products and provides contract manufacturing services, with capabilities ranging from lab-scale development through large-scale commercial production including anticancer drugs and complex APIs.

AqVida GmbH

Germany

AqVida GmbH is a German CDMO specializing in sterile oncology injectable products. Based in northern Germany, they manufacture cancer medicines using a state-of-the-art robotic filling line designed for aseptic production of cytostatics for parenteral use. Their facility features OEB5 containment with isolator technology for handling toxic parenteralia, with vial sizes from 2 to 100ml and batch sizes of 5 to 300 liters. They also provide GMP consulting services.

AsymBio (Asymchem Group)

China

AsymBio, a strategic business unit of Asymchem Group (stock code: 002821.SZ / 6821.HK), is a biologics CDMO focused on antibodies, recombinant proteins, bioconjugates (including ADCs), and mRNA. They provide end-to-end services from cell line construction through commercial manufacturing, with a 130,000+ sq meter Shanghai Fengxian facility featuring 200L/500L/2000L single-use bioreactors. They have supported FDA IND approvals for partners including Radiopharm Theranostics.

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.

Ajinomoto Bio-Pharma Services

Belgium

Ajinomoto Bio-Pharma Services (Aji Bio-Pharma) is a fully integrated global CDMO providing comprehensive development and cGMP manufacturing services for both small and large molecule pharmaceuticals. With facilities in Belgium, the United States, Japan, and India, the company offers platform technologies including oligonucleotide manufacturing, ADC conjugation, small molecule API synthesis, and aseptic fill-finish services. The Althea fill-finish site was acquired by PCI Pharma Services.

SK Pharmteco is a leading global CDMO providing drug development and manufacturing services across small molecules, gene therapy, and analytical testing. The company operates cGMP facilities in the United States (240-acre California headquarters in Rancho Cordova, King of Prussia PA), Ireland (Dublin - 60+ years of API production), South Korea, and France. They offer custom API manufacturing including HPAPIs, viral vector manufacturing (lentivirus via LentiSure and AAV via AAVelocity platforms, 230+ batches manufactured, 100+ supporting clinical trials), plasmid DNA manufacturing, and analytical services. Recently invested in expanding peptide development capabilities and opened a new HPAPI testing lab.

Syngene International

India

Syngene International is a leading Indian Contract Research, Development and Manufacturing Organization (CRDMO) that provides integrated services spanning drug discovery through commercial manufacturing for both small and large molecules. The company has long-term research collaborations with Bristol Myers Squibb (extended until 2035) and Amgen. Syngene recently opened its first US manufacturing facility in Rockville, Maryland, and added a bioconjugation suite in Bengaluru for end-to-end ADC development. The company has 20 kL single-use drug substance capacity for biologics.

BSP Pharmaceuticals

Italy

BSP Pharmaceuticals is an Italian CDMO specializing in cytotoxic, ADC (antibody-drug conjugate), and non-cytotoxic sterile injectable manufacturing. The company provides development, clinical, and commercial supply services including API synthesis, ADC conjugation and fill/finish, and oral solid dose manufacturing, with FDA and EMA approved facilities near Rome.

Pfizer CentreOne

Belgium

Pfizer CentreOne is a global CDMO embedded within Pfizer, specializing in commercial manufacturing of oral solid doses, sterile injectables, biologics including monoclonal antibodies, and antibody-drug conjugates. It leverages Pfizer's global manufacturing network across six continents with cGMP-compliant sites and over 170 years of pharmaceutical manufacturing expertise, backed by $1B+ annual manufacturing investments.

Pierre Fabre (CDMO)

France

Pierre Fabre CDMO is the contract development and manufacturing arm of the Pierre Fabre Group, a French pharmaceutical and dermo-cosmetics company. Offers over 20 years of CDMO services across pharma and non-pharma active ingredients, dry forms, non-sterile liquids, and biologics including monoclonal antibodies and ADCs. Operates R&D site in Toulouse and 3+ industrial sites in France. Expertise spans extraction, chromatographic purification, chemical synthesis, cytotoxic compound production, plant cell culture, and supercritical CO2 technology. Manufactures 2,100 metric tons of plant extracts and 100+ active ingredients annually.

Synbias Pharma AG (Synbias–Gemini Group)

Germany

Synbias Pharma AG (Synbias-Gemini Group) is a Swiss-headquartered pharmaceutical company specializing in the development and manufacturing of highly potent Active Pharmaceutical Ingredients (APIs), primarily used in cancer therapies including anthracyclines and nucleosides. The production facility Gemini PharmChem is located in Mannheim, Germany. The company holds 30-50% global market share for particular oncology APIs and ships to 21 countries. The group has passed 17 regulatory inspections including FDA, ANVISA, and German cGMP.

Symbiosis Pharmaceutical Services

United Kingdom

Symbiosis Pharmaceutical Services is a world-class sterile fill-finish CDMO based in Stirling, UK, specializing in the GMP manufacture of liquid and lyophilized biological and small molecule drug products. The company serves clinical trial and commercial scale with FDA-inspected and MHRA-licensed facilities. Symbiosis has manufactured its first 10,000-vial commercial batch for a cancer immunotherapy currently in Phase III trials. The company handles a full range of biologics including ATMPs, viral vectors, mAbs, ADCs, RNA/peptide therapies, and vaccines.

Heraeus Precious Metals GmbH & Co. KG

Germany

Heraeus Precious Metals GmbH & Co. KG is the pharmaceutical ingredients division of the Heraeus Group, specializing in the production of generic highly potent active pharmaceutical ingredients (HPAPIs) for cancer treatment. The company is the global market leader for platinum-based active ingredients including cisplatin, carboplatin, and oxaliplatin. In 2021, Heraeus made a multi-million euro investment expanding HPAPI manufacturing capacity in Hanau, Germany.

NJ Bio, Inc.

India

NJ Bio, Inc. is a premier CRO/CDMO specializing in antibody-drug conjugates (ADCs), antibody-oligonucleotide conjugates, and related bioconjugation chemistry. The company provides integrated chemistry services from discovery through GMP manufacturing, including custom synthesis of payloads, linkers, drug-linkers, and bioconjugation. NJ Bio has facilities in Princeton, New Jersey with specialized laboratories for high-potency API handling.

BirdoTech is a Shanghai-based CRO/CDMO providing drug discovery and custom synthesis services to pharmaceutical companies worldwide. The company has CDMO manufacturing sites in Chongqing (cGMP), Shanghai (GMP-like), and Shandong (non-GMP), supporting research through manufacturing stages. This is a duplicate entry for the same company as Birdo (Shanghai) Pharmatech Co., Ltd.

Hikma Pharmaceuticals

Algeria

Hikma Pharmaceuticals is a global pharmaceutical company with 29 manufacturing plants across the US, Europe, and MENA, producing injectable, oral, and respiratory medicines. The company offers CMO services and has announced a $1 billion investment by 2030 to expand US manufacturing and R&D capabilities. Hikma has 76 FDA-approved products, produces 500 million injectable units annually, and has maintained zero critical FDA observations in 20+ years.

Aragen Life Sciences Ltd.

India

Aragen Life Sciences Ltd. (formerly GVK Biosciences) is a CRDMO (Contract Research, Development, and Manufacturing Organization) headquartered in Hyderabad, India, with over 4,000 scientists. They provide integrated services spanning small molecules and large molecules (biologics) from discovery through commercialization. Their capabilities include HPAPI handling (cytotoxics, immunosuppressants, ADC toxins), particle science, process validation, and IND enabling services across multiple FDA-registered facilities.

Lonza

Switzerland

Lonza is a pioneer and world leader in the CDMO industry, founded in Switzerland in 1897. The company provides integrated development and manufacturing services across biologics, small molecules, cell and gene therapy, mRNA, and bioconjugates (ADCs/HPAPIs). With over 20,000 employees across five continents, Lonza serves the global pharmaceutical, biotech, and nutrition industries with end-to-end capabilities from early development to commercial-scale manufacturing.

AMPAC Analytical is part of SK pharmteco, a major integrated CDMO providing custom small molecule API development and manufacturing, viral vector and gene therapy CDMO services, and comprehensive analytical testing. SK pharmteco operates FDA/EMA/PMDA-inspected facilities across the US, Korea, Ireland, and France with capabilities spanning from clinical trials through commercial scale manufacturing.

ScinoPharm (scinopharm.com)

China

ScinoPharm Taiwan is a CDMO headquartered in Tainan Science Park, Taiwan, specializing in high-tech oncology APIs, peptide synthesis, and sterile injectable drug products. With FDA-approved facilities and 18 flexible manufacturing lines, ScinoPharm provides end-to-end services from API development through sterile injectable fill/finish, with a strong focus on complex generics and oncology therapeutics.