Regulatory Support CDMOs

Afton Scientific

United States

Afton Scientific is a pharmaceutical CDMO with over 20 years of expertise in aseptic manufacturing for biologics and small molecules. The company operates FDA-inspected facilities with a 99.9% on-time delivery rate and is investing in multi-year expansion of sterile fill-finish capabilities, including new technologies for improved efficiency and increased production capacity.

Akron Biotech

United States

Akron Biotech is a leading contract manufacturing organization (CMO/CDMO) providing cGMP-compliant solutions for cell and gene therapy. The company manufactures cytokines, growth factors, media, buffers, and transfection/transduction reagents, and recently expanded to a second 60,000 sq ft biologics manufacturing facility in Sarasota, Florida, to support growing demand for ancillary materials in cell and gene therapy.

Altasciences

Canada

Altasciences is a North American CRO/CDMO offering integrated early-phase drug development services. The company provides preclinical safety testing, clinical pharmacology (Phase I-II), bioanalysis, and manufacturing/analytical services including formulation development, drug product manufacturing (tablets, capsules, suspensions, creams, terminally sterilized injectables), and ICH stability testing, with DEA licensing for Schedule I-V substances.

AmbioPharm

China

AmbioPharm is a global peptide CDMO founded in 2005 and headquartered in North Augusta, South Carolina, USA. The company specializes in developing and manufacturing custom peptide APIs for pharmaceutical and biotech companies, with FDA-inspected facilities in the US and China and one of the largest peptide manufacturing capacities in the world.

American Injectables

United States

American Injectables is a privately held, FDA-approved CDMO specializing in sterile injectable drug products. Based in Florida, the company provides end-to-end services from formulation development through commercial manufacturing, with capabilities in aseptic fill/finish for vials and syringes, analytical testing, packaging, and serialization.

Ami Lifesciences Pvt Ltd

India

Ami Lifesciences Pvt. Ltd. is one of India's fastest-growing API manufacturing companies, established in 2006 in Vadodara, Gujarat. The company manufactures 88+ APIs across multiple therapeutic areas with 69 DMFs filed globally, operating three manufacturing plants with 1,500 metric tons of production capacity and offering CDMO/custom synthesis services.

Andelyn Biosciences

United States

Andelyn Biosciences is a gene therapy and viral vector CDMO with deep expertise in the development and production of viral vectors. The company has produced 450+ cGMP clinical batches, supported 75+ INDs, and operates 225,000+ sq ft of facility space. Andelyn offers viral vector manufacturing, plasmid manufacturing, process development, and laboratory services, with a proprietary AAV Curator platform.

Angelini Pharma (Angelini Fine Chemicals)

Italy

Angelini Fine Chemicals, part of the Angelini Pharma group, is a leading Italian API CDMO with over 50 years of experience in small molecule API development and manufacturing. They offer custom synthesis, process development, and commercial-scale API production for branded and generic pharmaceutical companies.

Apeloa Pharmaceutical

China

Apeloa Pharmaceutical is a major Chinese CDMO and API manufacturer, publicly traded as part of the Hengdian Group, with over 7,000 employees. They are China's #2 API exporter and a top-5 Chinese CDMO. Their services span API & intermediates, CDMO, finished dosage forms, and aesthetic/care ingredients, with seven API sites and two drug product sites. They have passed 20+ US FDA inspections.

Applied Laboratories, Inc.

United States

Applied Laboratories, Inc. is a cGMP contract manufacturer headquartered in Columbus, Indiana, specializing in liquids, semi-solids (creams, ointments, gels), and topical pharmaceutical products. Originally founded in 1984 as an FDA regulatory consulting firm, it evolved into a full-service contract manufacturer with 200,000 sq-ft of cGMP facilities registered for both drug and medical device production. They provide formulation development through commercial-scale manufacturing, filling, labeling, and packaging for OTC pharmaceuticals and healthcare products.

Argenta (Animal Health CRO/CDMO)

Germany

Argenta is the world's only global animal health contract research, development, and manufacturing organization (CRO/CDMO). They provide end-to-end support for veterinary medicinal products including immunologicals/vaccines, biological non-immunologicals, pharmaceuticals, and novel therapies. They offer contract manufacturing for both sterile and non-sterile animal health products, with FDA-registered facilities across multiple sites globally. Note: they serve the animal health market, not human pharmaceuticals.

Argonaut Manufacturing Services

United States

Argonaut Manufacturing Services is a U.S.-based CMO headquartered in Carlsbad, California, specializing in aseptic fill and finish, lyophilization (LyoDose beads, LyoDots, powders, and cakes), in-vitro diagnostics (IVD) and life science kit manufacturing, and drug-device combination products (DDCP). They recently secured $45M in financing to expand their aseptic fill/finish capabilities. They serve pharmaceutical, life science, IVD, and applied markets from small N-of-1 fills to high-scale commercial products.

Artesan Pharma

Germany

Artesan Pharma is a German full-service CDMO based in Luechow, specializing in pharmaceutical contract development and manufacturing with 501-1,000 employees. They provide services spanning formulation development to commercial manufacturing across multiple dosage forms including oral solid doses (tablets, capsules, pellets), sterile prefilled syringes with innovative production processes, and liquids. They also offer serialization, final packaging (blister), and terminal steam sterilization capabilities.

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.

Aspire Pharmaceuticals (Aspire LLC)

United States

Aspire Pharmaceuticals (Aspire LLC) is a contract manufacturer specializing in softgel encapsulation and oral solid dosage forms. They offer proprietary technologies including GummiCore (gummy-centered softgels), Vecell Liposomes (liposomal delivery), and softgel manufacturing using tapioca, carrageenan, and gelatin. They also have FDA-approved inhaled and ophthalmic products in their portfolio.

Astrea Pharma

France

Astrea Pharma is a CDMO founded with the purpose of building a customer-focused manufacturing network covering development to commercial supply. They acquired the Fontaine-les-Dijon solid dose manufacturing site from Recipharm and offer oral solid dose and aseptic manufacturing capabilities from development through commercial supply, with a focus on efficiency and value in the pharma supply chain.

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.

Bachem AG

Switzerland

Bachem AG is a leading global CDMO specializing in the development and manufacture of peptides and oligonucleotides, with over 50 years of experience. Headquartered in Bubendorf, Switzerland, Bachem provides end-to-end services from research-grade synthesis and CMC development through GMP-scale commercial API manufacturing for pharmaceutical and biotechnology companies worldwide. The company leverages innovative technologies including Multi-Column Solvent Gradient Purification (MCSGP) for higher throughput and purity. Bachem holds a strong regulatory track record and a partnership with Eli Lilly for oligonucleotide-based drug substance development and manufacturing (since April 2022). They serve the peptide therapeutics market including GLP-1 receptor agonists and other complex peptide APIs.

Basic Pharma

Netherlands

Basic Pharma is a full-service CDMO based in the Netherlands specializing in regulated pharmaceutical product development, manufacturing, and commercialization. They offer GMP-compliant manufacturing of medicinal products and formulations, active pharmaceutical ingredients, and analytical testing from lab scale to early clinical phase and beyond. Their state-of-the-art facility includes GMP-compliant clean rooms.

BCN Peptides

Spain

BCN Peptides (BCNpeptides) is a European leader in peptide API manufacturing with over 30 years of experience. As a GMP-certified CDMO approved by USFDA and EDQM, they specialize in solid phase synthesis of peptides from milligrams to multi-kilogram batches. They offer custom synthesis of new chemical entities for preclinical through commercial stages, generic peptide APIs, and GMP neoantigen peptides for personalized medicine.

BDD Pharma

United Kingdom

BDD Pharma is a UK-based combined CDMO and CRO specializing in lean early-stage drug development. With over 25 years of experience, they provide formulation development, GMP manufacturing, and clinical testing under one roof. Their new GMP manufacturing facility in Glasgow has been approved by MHRA for investigational medicinal products (IMP) and placebo manufacturing.

Benta Lyon SAS

France

Benta Lyon SAS is a French pharmaceutical company and CDMO established nearly 50 years ago in Saint-Genis-Laval near Lyon. They specialize in the development and manufacturing of generic pharmaceutical products with GMP/BPF-certified production facilities. Their site covers 16 hectares and focuses on dry, paste, and non-sterile liquid dosage forms, with plans to add sterile injectable capabilities. Their sister company Strategie Sante provides regulatory affairs, product development, and market access support.

BioCina

Australia

BioCina is a global end-to-end biologics CDMO and the only biologics CDMO in Australia approved by the US FDA. Following the merger with NovaCina, the company provides comprehensive biologics CDMO services spanning cell line development, process development, analytical development, GMP manufacturing of biologics drug substance and drug product, and mRNA manufacturing. Operates facilities in Adelaide, Australia with GMP manufacturing capacity up to 1,000L bioreactors.

BioConnection

Netherlands

BioConnection is a contract manufacturing organization (CMO) based in Oss, The Netherlands, specializing in aseptic fill and finish services for sterile drug products. The company offers flexible development and GMP-compliant manufacturing for both innovative and generic biopharmaceutical companies, with capabilities in vials, syringes, and lyophilized products. Partnered with AGC Biologics for drug product services. FDA-registered with 17 inspections (6 NAI, 11 VAI), demonstrating extensive regulatory history.

Biologics Manufacturing Centre (BMC) Inc.

Canada

Biologics Manufacturing Centre (BMC) Inc. is a Canadian end-to-end GMP biomanufacturing facility with a public good mandate, established to secure domestic biologics supply. Licensed by Health Canada (DEL 3-002766-A and 3-002818-A) to manufacture and test biological products and vaccines. The facility is BSL-2 accredited and supports orphan drug development for rare and genetic diseases. Subsidiary of the National Research Council Canada.

Biopharma Group CDMO

United Kingdom

Biopharma Group is a UK-headquartered CDMO specializing in lyophilized (freeze-dried) and liquid pharmaceutical formulations for clinical manufacturing. They offer services from R&D through technical transfer, engineering batches, and clinical manufacturing to Annex 1 GMP standards. The company can handle substances classified up to OEB 6 and also manufactures non-sterile diagnostic formulations. They operate three Category D cleanrooms and a dedicated lyophilization center.

Birgi Mefar Group (BMG)

Turkey

Birgi Mefar Group (BMG) is one of Turkey's leading producers of sterile injectable products, recently acquired by Abu Dhabi-based ADQ. The company provides contract manufacturing services for sterile injectables with manufacturing sites in Turkey. BMG is listed on pharmaceutical CDMO directories and provides fill-finish and sterile manufacturing services.

Bliss GVS Pharma Ltd.

India

Bliss GVS Pharma Ltd. is an Indian pharmaceutical company and the world's largest manufacturer of suppositories and pessaries, operating in 60+ international markets. The company operates six manufacturing units in Maharashtra and Daman with WHO-GMP and EU-GMP (PIC/S) approvals, producing suppositories, pessaries, tablets, dry syrups, dry powder injectables, ointments, creams, and gels. Bliss GVS offers contract manufacturing (CMO/CDMO) services alongside its own product portfolio.

Bluepharma

Portugal

Bluepharma is a Portuguese CRDMO with over 55 years of experience, offering an integrated approach from R&D through to commercial manufacturing of medicines. The company produces 2 billion units of oral solid pharmaceutical forms and has an industrial plant for high potency products. Bluepharma's facilities are EMA/Infarmed and FDA approved, and the company has expanded into advanced therapies beyond small molecules.

Bruschettini S.r.l.

Italy

Bruschettini S.r.l. is an Italian pharmaceutical company based in Genoa that provides contract manufacturing services for sterile injectable and lyophilized products. The company is listed on CMO/CRO directories and appears in contract pharmaceutical dose manufacturing industry reports as a provider of sterile manufacturing capabilities.

Cellab CDMO

Andorra

Cellab CDMO is a Contract Development and Manufacturing Organization based in Andorra, specializing in Advanced Therapy Medicinal Products (ATMPs) including cell and gene therapies. The company provides end-to-end services from concept and early-stage development through clinical programs and commercialization under GMP. Cellab supports therapy developers with an agile approach to accelerate ATMP development from bench to bedside.

CellEasy

France

Cell-Easy (CellEasy) is a French CDMO specializing in GMP cell therapy manufacturing, supporting academic laboratories, biotechs, and pharma companies through development and clinical programs. The company has manufactured over 1,000 clinical doses in its GMP facility and has handled 15+ cell types including T cells, NK cells, T regs, MSCs, iPSCs, and immortalized cell lines across 50+ development programs. Cell-Easy follows ICH Q2(R1), European Pharmacopoeia, EMA/MHRA, and US Pharmacopoeia standards.

Cellex Cell Professionals GmbH

Germany

Cellex Cell Professionals GmbH is a European CDMO with over 10 years of experience in autologous and allogeneic cell therapy, partnering with top pharma companies, biotech firms, and academic institutions for clinical trials and post-approval commercial production. Three approved CAR-T therapies are produced in Cellex's GMP-compliant facilities. The company provides full-service capabilities including cell collection, manufacturing of ATMPs/CGT products, process development and validation, supply chain management, GMP audits of medical facilities, and consulting from preclinical development to commercialization.

CELLforCURE by SEQENS

France

CELLforCURE by SEQENS is a leading EMA-authorized CDMO dedicated to the development and commercial manufacturing of cell and gene therapies (ATMPs). Located near Paris, the company operates a 10,000 m2 site with 3,000 m2 of GMP area featuring 7 independent GMP manufacturing lines, 48 cleanrooms, and an 800 m2 dedicated QC lab. With over 15 years of track record, CELLforCURE has completed 25+ tech transfers, manufactured 600+ autologous CAR-T commercial doses and 10,000+ allogeneic CAR-T clinical vials.

Celonic

Germany

Celonic is a Swiss-based 'Pure Play' biologics CDMO offering end-to-end drug substance development and manufacturing solutions for monoclonal antibodies, bispecifics, and other complex molecules. The company is a pioneer in next-generation bioprocessing technologies including process intensification and full perfusion. Celonic operates facilities in Basel, Switzerland and Heidelberg, Germany, and has a strategic alliance with CARBOGEN AMCIS for integrated ADC development and manufacturing.

Cenexi

Belgium

Cenexi is a Belgian/French CDMO specializing in sterile products, biological and injectable pharmaceutical manufacturing. The company operates four manufacturing sites in Europe, including sites in Fontenay-sous-Bois and Herouville-Saint-Clair (France), Osny (France, for highly active solid pharmaceutical forms), and Belgium. Cenexi offers services from development to commercial production for pre-filled syringes, vials, lyophilized products, tablets, capsules, and syrups, with FDA-registered manufacturing operations.

Center for Breakthrough Medicines (CBM)

United States

Center for Breakthrough Medicines (CBM) is a cell and gene therapy CDMO based in King of Prussia, Pennsylvania, operating at The Discovery Labs campus. CBM offers comprehensive services including plasmid manufacturing (Precision Plasmids), viral vector manufacturing (Genesis Vector Manufacturing Solutions), cell therapy manufacturing, and analytical testing (Analytical Accelerator for AAV testing). SK Pharmteco acquired controlling interest in CBM, and the company has capacity to manufacture therapies for 10,000+ patients.

Centre c3i

Canada

C3i Center Inc is the first CDMO in Canada to receive approval for a Drug Establishment License to commercially produce cell therapy drug products. Based in Montreal, the company provides tailored cell and gene therapy CDMO services from development through commercial manufacturing.

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.

Chempro Pharma

India

Chempro Pharma Pvt. Ltd. is an Indian CDMO and exporter of APIs, intermediates, KSM, impurities, pellets, and finished dosage forms (FDF). The company operates WHO/EU GMP-approved facilities and is ISO 9001 certified, with manufacturing sites in Vapi, Gujarat and Maharashtra. It provides contract manufacturing services for both APIs and finished formulations.

Chunghwa Chemical Synthesis & Biotech Co., Ltd. (CCSB)

Taiwan

Chunghwa Chemical Synthesis & Biotech Co., Ltd. (CCSB), founded in 1964 and operating as Cenra API Solutions, is one of the largest API manufacturers in Taiwan. The company provides cGMP toll manufacturing and contract research services with FDA/EU-approved facilities, producing APIs across antifungal, immunosuppressant, oncology, cardiovascular, and peptide drug categories.

CKD BiO

South Korea

CKD BiO is a South Korean contract development and manufacturing organization specializing in APIs and intermediates at its cGMP facility approved by US and EU authorities. The company has over 1,500 m3 of fermentation capacity ranging from 12 m3 to 100 m3 scale, with expertise across a broad spectrum of microorganisms including streptomyces, fungi, bacteria, and yeast, supported by decades of accumulated know-how in fermentation-based API manufacturing.

Coating Place Inc

United States

Coating Place Inc is a Wisconsin-based pharmaceutical CDMO founded in 1976, specializing in Wurster fluid bed coating technology for oral solid dosage forms. The company operates FDA- and EMA-approved GMP facilities in Verona and Sauk City, Wisconsin, with 24 proprietary Wurster fluid bed coaters handling batches from 0.010 kg to 800 kg, and is DEA-licensed for Schedule I-V controlled substances. The company celebrated its 50th anniversary in 2026.

Codis

United States

Codis is a global CDMO specializing in commercial-scale spray drying, amorphous solid dispersions (ASD), and particle engineering technologies. Formed through the integration of Particle Dynamics in the US and the Haverhill, UK facility previously operated by EUROAPI, the company operates over 400,000 sq ft of cGMP manufacturing space across three sites with a 30-year regulatory track record, and is the world's leading manufacturer of Sevelamer API producing hundreds of metric tons annually.

CorePharma LLC

United States

CorePharma LLC, founded in 1998 and headquartered in Middlesex, NJ, is a CDMO specializing in oral solid dosage forms including IR and ER tablets and capsules. The company offers end-to-end services from product development and contract manufacturing to packaging and analytical testing, with cGMP-compliant FDA & DEA registered facilities producing over 2 billion units annually.

CRAMSN Research Park

India

CRAMSN Research Park is an India-based contract research, development, and manufacturing organization offering end-to-end CRO, CDMO, and CMO solutions. The company provides drug substance (API) and drug product manufacturing with multiple facilities in India and a facility in New Jersey, USA, committed to sustainable practices including green chemistry and solar-powered operations.

Custom Pharma Services

United Kingdom

Custom Pharma Services is a UK-based CDMO founded in 1979 in Brighton, specializing in oral solid dose manufacturing and packaging for clinical and commercial use. The company is MHRA-approved and FDA-inspected, with capacity exceeding 1.5 billion tablets and 250 million capsules annually. Custom Pharma handles controlled drugs, hormonal products, and has launched Centrix Pharma Solutions for early-stage development.

Dalton Pharma Services

Canada

Dalton Pharma Services is a Canadian CDMO and subsidiary of Seikagaku Corporation Japan, providing integrated drug discovery, development, and manufacturing services. The company is FDA-inspected and Health Canada-approved with over 35 years of experience, specializing in custom chemical synthesis, cGMP API manufacturing, sterile vial filling, and formulation development including liposomal formulations. Dalton recently announced major expansion of its commercial sterile manufacturing capacity.