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.

• Alcami Corporation

  Alcami is a US-based contract development and manufacturing organization with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery. The company provides fully integrated services across three core areas: **Drug Product Manufacturing:**…

• 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.

• 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.

• Ascendia Pharmaceutical Solutions

  Specialty CDMO offering formulation development, analytical services, and cGMP manufacturing for small molecules and biologics from preclinical through Phase 1 and commercialization.

• 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

  CDMO specializing in cytotoxic and high-potency oncology drugs, ADCs, peptides, proteins, oligonucleotides, and lipid-based formulations with GLP development through cGMP commercial manufacturing across segregated high-containment facilities.

• 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 from early formulation to commercial-scale production, with cGMP capabilities including spray drying, particle engineering, and complex oral dosage forms.

• 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.

• 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

  Leading global CDMO offering end-to-end development and manufacturing for pharma, biotech, and consumer health—spanning oral dose, biologics, cell and gene therapies, clinical supply, and specialty formulations with advanced technologies and worldwide GMP capacity.

• 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.

• 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. The company develops mesenchymal-like adherent stromal cells (MLASCs), Natural Killer (NK) cells,…

• Charles River Cell & Gene Therapy

  Integrated CDMO offering discovery through commercial manufacturing for cell and gene therapies, with expertise in viral vectors, cell therapy manufacturing, and regulatory support across North America, Europe, and Asia.

• 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.

• 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.

• 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.

• Ethypharm

  Ethypharm is a leading mid-size international specialty pharmaceutical company with strong European roots. The company manufactures and provides essential medicines with a focus on two core therapeutic areas: Central Nervous System (CNS) treatments for severe pain and…

• 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.

• 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.

• Jubilant HollisterStier

  Comprehensive sterile fill-finish and lyophilization CDMO with decades of experience, advanced automation, and white-glove service for global pharmaceutical partners.

• KBI Biopharma, Inc.

  Global CDMO offering cell line development, process development, analytical services, and cGMP clinical and commercial manufacturing for biologics including monoclonal antibodies and recombinant proteins.

• Kindeva Drug Delivery

  Purpose-driven CDMO specializing in injectable, inhalation, and dermal drug delivery with 155,000+ sq. ft. of aseptic operations and fill-finish capabilities.

• Laurus Labs

  Global pharmaceutical company specializing in APIs, formulations, and CDMO services.

• Lupin Limited

  Global pharmaceutical manufacturer with robust quality systems aligned to US FDA, UK MHRA, and EU GMP standards; operates diversified manufacturing across generics, complex formulations, and specialty segments with advanced automation and digital quality infrastructure.

• Nuvisan

  Full-service CRO and CDMO with specialized competency centers in drug discovery, formulation development, GMP manufacturing, and bioanalytical services across Germany and France.

• Oxford Biomedica

  Global viral vector CDMO with 30 years of expertise in lentivirus, AAV, and adenovirus manufacturing. Delivers end-to-end GMP solutions from preclinical through commercial launch, with facilities across UK, US, and Europe.

• Patheon (Thermo Fisher Pharma Services)

  Global CDMO partner offering 360° integrated drug development solutions from early-stage R&D through clinical supply and commercial manufacturing for biologics and small molecules.

• Pfizer CentreOne

  Award-winning CDMO specializing in commercial manufacturing of oral solids, sterile injectables, and biologic drug products with Pfizer's technical expertise and global network.

• PharmaBlock

  Leading provider of innovative chemistry products and services for pharmaceutical R&D and commercial manufacturing, with expertise in process development, GMP manufacturing, and low-carbon chemistry solutions.

• Pharmaron

  Premier life science CRO and CDMO offering integrated R&D and manufacturing across drug discovery, preclinical, clinical development, and commercialization for small molecules, biologics, and cell & gene therapies. 25,000+ employees across China, US, and UK.

• Piramal Pharma Solutions

  CDMO specializing in HPAPIs, ADCs, peptides, vaccines, and biologics with 4,700+ team members across 15 global sites and 500+ customers. Offers integrated development and manufacturing with backward integration capabilities and global program management.

• Pluri

  Full-service CDMO specializing in cell therapy manufacturing with GMP facilities, proprietary packed-bed expansion technology, and regulatory approvals from FDA, EMA, PMDA, and other key agencies for clinical-stage production.

• PolyPeptide Group

  Specialized global CDMO for peptide-based active pharmaceutical ingredients, supporting development and manufacturing of proprietary and generic APIs with expertise in peptide synthesis and GMP manufacturing.

• Quotient Sciences

  Integrated CDMO offering drug product formulation and manufacturing for small molecules and synthetic peptides, with 30+ years of experience and scalable capacity from clinical to 500 kg commercial batches across US and UK facilities.

• SEQENS

  Global CDMO and specialty ingredients manufacturer with 16 production sites and 9 R&D centres offering custom development and GMP manufacturing of pharmaceutical APIs, intermediates, and specialty chemicals from preclinical to commercial scale.

• SK pharmteco

  SK pharmteco is a leading global contract development and manufacturing organization (CDMO) with a network of CGMP facilities across four countries. The company specializes in three primary service areas: **Small Molecules** Scalable, reliable, and high-quality small molecule…

• Sai Life Sciences

  Integrated CRDMO offering discovery, development, and manufacturing services for small molecule NCE programs across 280+ global pharma and biotech clients.

• Samsung Biologics

  Leading CDMO offering end-to-end biologics development and manufacturing from cell line development through aseptic fill-finish, with capabilities in drug substance, drug product, ADC, and mRNA services.