CDMOs offering CMC Regulatory Submission Support with Small Molecule

Matching companies

• 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.

• 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.

• 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.

• 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.

• 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.

• Burrard Pharmaceuticals

  Vancouver-based CDMO delivering technology transfer, formulation development, and GMP manufacturing for 75+ molecules across oncology, diabetes, and respiratory therapeutics since 2005.

• 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.

• 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.

• 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.

• CuriRx, Inc.

  CuriRx provides formulation development, advanced bioprocessing, and analytical services to pharmaceutical companies. Capabilities include prefilled syringes, lyophilization, cell line development, upstream/downstream process development, and CMC analytical support via the CuriLytics® platform.

• 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.

• 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.

• Ethypharm

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

• Flamma

  Privately held small molecule CDMO with FDA-inspected cGMP facilities in Italy, USA, and China, offering custom manufacturing, development, and specialized technologies including HPAPI, continuous flow, and cryogenic API synthesis from early-stage to commercial scale.

• Gannet Biochem

  Specialized CDMO offering custom polymer science, PEG chemistry, bioconjugation, and cGMP manufacturing services from early discovery through commercial scale, with 30+ years of expertise rooted in Shearwater Polymers and Nektar Therapeutics.

• 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.

• 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.

• IDT Australia

  IDT Australia is a cGMP CDMO delivering end-to-end pharmaceutical development and manufacturing services from active pharmaceutical ingredients to finished dosage forms, with expertise in small molecule APIs, specialty orals, advanced therapies, and integrated regulatory support.

• Laurus Labs

  Global pharmaceutical company specializing in APIs, formulations, and CDMO services for small molecule and biologics.

• Lifecore

  Lifecore is a sterile injectable CDMO with 60 years of regulatory experience, offering end-to-end services including formulation and process development, aseptic manufacturing, fill-finish, analytical testing, stability, and assembly and packaging for drugs, biologics, medical devices, and combination products.

• 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.

• Neuland Laboratories

  Global API CDMO supporting biotechnology and pharmaceutical companies in design, development, and manufacturing of complex active pharmaceutical ingredients from early-stage drug development through commercial scale.

• Nuvisan

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

• Optimus Drugs Private Limited

  Leading CDMO delivering end-to-end small molecule drug substance and drug product development and manufacturing from clinical to commercial scale, with 21+ years of expertise and GMP-certified facilities.

• PCI Pharma Services

  Global CDMO with 8,000+ employees across 38 GMP facilities offering sterile and non-sterile development, manufacturing, fill-finish, lyophilization, prefilled syringes, drug-device combinations, cold chain packaging, and clinical trial services.

• PHT International, Inc.

  PHT International is a Contract Research, Development, and Manufacturing Organization (CRDMO) offering small-molecule process R&D, cGMP manufacturing from milligrams to multi-tons, and chemical sourcing with global facilities across North America, Europe, and Asia.

• PI Health Sciences

  PI Health Sciences is an integrated CRDMO offering end-to-end drug discovery, development, and manufacturing services with R&D and manufacturing locations in Europe and India.

• Patheon (Thermo Fisher Pharma Services)

  Patheon is a trusted global contract development and manufacturing organization (CDMO) partner owned by Thermo Fisher Scientific, offering 360° integrated solutions from early-stage R&D through clinical supply and commercial manufacturing.

• 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.

• Pyramid Pharma Services

  US-based aseptic fill-finish CDMO specializing in parenteral biologics, peptides, and small molecules from development through commercial supply, with formulation, analytical, stability testing, and vial/syringe/cartridge filling capabilities.

• 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 CDMO offering comprehensive drug development and manufacturing services.

• Sai Life Sciences

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