CDMOs offering CMC Regulatory Submission Support (CDMO)

Matching companies

• AGC Biologics

  Global CDMO offering development and manufacturing for protein expression biologics, pDNA, mRNA, viral vectors (AAV, LVV, RVV), and genetically engineered cells with scale-out manufacturing capabilities.

• ARSI Canada Inc

  ARSI Canada is a specialized CRO offering custom synthesis, API scale-up, analytical method development, and drug development services with over 50 years of combined experience and a GMP manufacturing facility in Bangladesh.

• Abzena

  Fully integrated biologics and bioconjugates CDMO+CRO offering drug design, development, and GMP manufacturing for antibodies, ADCs, AOCs, RDCs, and vaccines from discovery through commercial scale.

• Adragos Pharma

  Global CDMO headquartered in Munich offering end-to-end development and manufacturing for small molecules and biologics, including sterile/non-sterile liquids, solids, semi-solids, lyophilization, and prefilled syringes across seven facilities in Europe and Japan.

• Akums Drugs and Pharmaceuticals Ltd.

  India's largest CDMO with 15+ state-of-the-art facilities and 30% domestic market share, manufacturing 4,100+ formulations across tablets, capsules, injectables, APIs, and specialty dosage forms under WHO-GMP, USFDA, EU-GMP, and TGA compliance.

• Alcami Corporation

  US-based CDMO with 45+ years of experience providing integrated lab services, sterile and oral solid dose drug product manufacturing, and cGMP pharmaceutical storage and support services.

• Aldevron

  Aldevron is a CDMO specializing in mRNA manufacturing with LNP encapsulation and fill/finish, viral vector production, plasmid DNA, and gene therapy solutions from discovery through commercialization.

• Almac Group

  Global CDMO with 7,900+ employees across 18 facilities, offering integrated drug development and manufacturing services including analytical development, formulation, process development, fill-finish, and specialized chemistry capabilities.

• Altruist Biologics

  Global CDMO offering end-to-end development and GMP manufacturing for monoclonal antibodies, bispecific antibodies, fusion proteins, recombinant proteins, and antibody-drug conjugates, with facilities in Suzhou and Hangzhou featuring up to 20,000-liter bioreactors.

• Andelyn Biosciences

  CDMO specializing in plasmid DNA and AAV viral vector manufacturing for cell and gene therapy, with digital-first platform emphasizing data integrity and collaboration.

• Ardena

  Ardena is an integrated CDMO and bioanalytical CRO specializing in advanced drug product development, nanomedicine, and bioanalysis for complex molecules including poorly soluble compounds, highly potent APIs, and controlled substances.

• Ascendia Pharmaceutical Solutions

  Ascendia is a specialty CDMO providing formulation development, analytical services, and GMP manufacturing for small molecules and biologics from pre-formulation through commercialization, with proprietary nanotechnologies including LipidSol, EmulSol, AmorSol, and NanoSol.

• Asymchem Laboratories

  Asymchem is a CDMO providing integrated API synthesis, drug product development, and biologics manufacturing with specialized capabilities in peptides, oligonucleotides, highly potent compounds, and flow chemistry.

• Axplora

  Global CDMO and API manufacturer specializing in complex small molecule development, ADC manufacturing, HPAPIs, and hazardous chemistry across ten production sites in Europe, India, and the US.

• BSP Pharmaceuticals

  BSP Pharmaceuticals is a CDMO specializing in development and manufacturing of cytotoxic oncology drugs, ADCs, peptides, proteins, and lipid-based formulations from preclinical GLP through commercial supply.

• Bachem

  Global leader in peptide and oligonucleotide development and manufacturing, offering GMP-compliant clinical and commercial supply from early research through commercial scale.

• Bend Bioscience

  U.S. pharmaceutical CDMO offering design, development, and manufacturing of oral solid and liquid dosage forms, from early formulation to commercial-scale production across three domestic locations.

• BioVectra

  North American CDMO specializing in clinical-to-commercial biologics, small molecules, HPAPIs, and bioreagents with 50+ years of microbial fermentation and complex chemistry expertise across cGMP facilities in Canada.

• Biocon

  Fully integrated biopharmaceutical company developing affordable biosimilars, generic formulations, and complex APIs for diabetes, cancer, and autoimmune diseases.

• Biomay AG

  GMP CDMO specializing in plasmid DNA, mRNA, and recombinant protein manufacturing from gene construction to market supply, with in-house mRNA lipid-nanoparticle formulation and aseptic fill-finish capabilities.

• Biospring

  Global CDMO leader in nucleic acid manufacturing and analysis (mRNA, ASO, siRNA, guide RNA, oligonucleotides) with nearly three decades of expertise, GMP certification since 2007, and support for 9 commercial programs across all clinical phases.

• CMC Pharmaceuticals, Inc.

  CMC Pharma provides integrated formulation development, analytical testing, stability studies, and cGMP manufacturing oversight for small molecule drug programs from preclinical through post-approval, with hands-on regulatory expertise and CMO management built in.

• CPC Scientific

  CPC Scientific provides GMP peptide and oligonucleotide manufacturing for Phase I through commercial programs, plus custom synthesis and FTE services for research applications.

• CRAMSN

  CRAMSN is a contract research, development, and manufacturing organization (CRO/CDMO/CMO) offering end-to-end solutions for drug substance and drug product development with GMP-certified facilities recognized by US, EU, Japan, and Canada regulatory authorities.

• Cambrex

  CDMO offering drug substance and drug product development, manufacturing, and analytical services across small molecules, peptides, and specialty chemistries.

• Carbogen Amcis

  Full-service CDMO offering integrated drug substance and sterile drug product development and manufacturing from early phase through commercialization, with specialized capabilities in API synthesis, process development, analytical services, and stability testing across multiple scales.

• Catalent

  Global CDMO providing end-to-end contract development and manufacturing for pharma, biotech, and consumer health. Delivers 60+ billion doses annually across small molecules, biologics, cell & gene therapies, and clinical supply.

• Cell Therapies

  GMP contract manufacturer of autologous and allogeneic cell therapies from first-in-human trials through commercial supply, with two decades of experience in CAR-T, mesenchymal stromal cells, TILs, and pluripotent stem cell derivatives. Offers end-to-end cold chain management, process development, quality control analytics, and regulatory consulting across Australia and Asia-Pacific.

• Cell and Gene Therapy Catapult

  UK-based innovation and manufacturing support organization for cell and gene therapies, offering infrastructure, expertise, and collaboration across the ATMP lifecycle.

• Cellares

  Cellares operates a global network of Smart Factories delivering integrated development and manufacturing (IDMO) services for cell therapies, with proprietary Cell Shuttle® and Cell Q™ platforms enabling cGMP-compliant, automated manufacturing and quality control at clinical and commercial scale.

• Celonic

  Swiss-based pure-play biologics CDMO specializing in next-generation bioprocessing technologies including process intensification and full perfusion to reduce cost of goods for biotech and biosimilar clients.

• Celularity

  Celularity is a clinical and commercial-stage biotechnology company specializing in off-the-shelf placental-derived allogeneic cell therapies and advanced biomaterial products.

• Charles River Laboratories

  Charles River Laboratories provides contract research, development, and manufacturing services across the full drug discovery and development continuum, supporting 80% of FDA-approved drugs over the past five years.

• Codis

  Global CDMO specializing in commercial-scale spray drying, amorphous solid dispersions, microencapsulation, and continuous granulation with 400,000 sq ft of GMP manufacturing across US and UK facilities.

• CordenPharma

  Full-service CDMO offering cGMP development and manufacturing of APIs, lipid excipients, drug products, injectables, peptides, LNPs, oligonucleotides, and oral solid dose across 10 facilities in 6 countries with 3000+ employees.

• Curia

  Global CDMO with 30+ years of experience offering integrated services across small molecule, generic APIs, sterile drug product, and biologics manufacturing, backed by 20+ facilities and 3,000+ professionals across North America, Europe, and India.

• Cytovance Biologics

  U.S.-based CDMO offering end-to-end biomanufacturing services for antibodies, recombinant proteins, vaccines, and other biologics modalities, with dedicated microbial and mammalian facilities and in-house cell line development capabilities.

• Delpharm

  Top-5 global CDMO with 18 production sites across Europe and North America, specializing in solid, semi-solid, non-sterile and sterile liquid dosage forms including prefilled syringes, nasal sprays, and injectables; capacity to produce over 300 million units annually.

• Dipharma

  Global CDMO and API manufacturer with 600 employees, 4 cGMP plants, and 75+ years of experience in hazardous chemical synthesis, offering exclusive synthesis services and catalogue APIs with FDA, AIFA, and PMDA inspections since 1970.

• Divi's Laboratories

  World's largest API manufacturer and trusted CDMO partner for 25+ years, offering generic APIs, custom synthesis, peptides, and nutraceutical ingredients to 100+ countries with complete backward integration and green chemistry principles.

• Dr. Reddy's Laboratories

  Integrated global pharmaceutical company manufacturing generics, APIs, biosimilars, and innovative medicines across 66 countries with capabilities in small molecule and biologics development and manufacturing.

• ElevateBio

  Advanced therapies CDMO providing discovery, process development, manufacturing, and regulatory support for cell therapies, viral vectors, mRNA, and gene editing programs from preclinical through commercial scale.

• Enable Biotech Ltd

  Enable Biotech provides clinical GMP manufacturing for cell therapies, exosome therapies, and gene therapies, with SwissMedic accreditation pending for gene therapy operations as of summer 2024.

• Ethypharm

  Ethypharm is a leading mid-size international specialty pharmaceutical company with strong European roots.

• FUJIFILM Biotechnologies

  CDMO partner offering end-to-end biologics development and manufacturing from pre-clinical through commercialization, with expertise in cell culture, microbial fermentation, cell and gene therapy, and cGMP manufacturing across US and European facilities.

• Forge Biologics

  Dedicated AAV gene therapy CDMO with a 200,000+ sq. ft. cGMP facility featuring 20 suites and bioreactors up to 5,000L, supporting 60+ clients across 35+ indications with high-yield manufacturing and seamless regulatory compliance.

• Glatt

  Glatt Pharmaceutical Services is a CDMO specializing in complex oral solid dosage forms, multiparticulate systems (pellets, micropellets, granules), and advanced drug delivery solutions including controlled release, solubility enhancement, and taste masking from early development through commercial manufacturing.

• Global Biotech Laboratories

  Global Biotech Laboratories is a peptide and oligonucleotide CDMO offering end-to-end contract development and manufacturing from route scouting through validated commercial supply, with cGMP and ICH Q7 compliance across manufacturing sites on three continents.

• Grand River Aseptic Manufacturing

  Sterile injectable CDMO specializing in fill-finish services for liquid and lyophilized vials, syringes, and cartridges, with Annex 1 compliant facilities and experience in biologics, small molecules, and vaccines.

• Grifols Partnership

  CDMO specializing in small molecule injectable products, including concentrated and diluted parenteral formulations and intravenous solutions, leveraging 100+ years of Grifols expertise.