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CDMO & Manufacturing

Contract development and manufacturing partners for drug substance and product.

140 suppliers in this category · Page 1 of 6

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How to choose CDMO & Manufacturing partners

This pharma CDMO directory lists U.S. contract development and manufacturing organizations for API, biologics, fill-finish, and cell and gene therapy programs. Sponsors searching for a list of CDMO companies or a free pharma CDMO directory should compare GMP credentials, modality fit, and DMF/CEP support before RFP release. Shortlist by phase scale (clinical vs commercial), verifiable FDA/EU GMP registration, and integrated vs API-only scope—then drill into enriched profiles with certifications, service tables, and primary-source evidence.

Procurement decision framework

Modality fit: API, biologics, and advanced therapies

CDMO selection starts with chemistry and modality—not a generic “list of CDMO companies.” Use the modality browse row above to align with how sponsors filter directories: API drug substance, biologics, cell and gene therapy, sterile fill-finish, and HPAPI.

Small molecule & API manufacturing

API CDMOs and CMOs must show synthetic route development, impurity control, and DMF or CEP filing support—the same intent cluster that ranks PharmaCompass for “GMP contract manufacturing APIs clinical commercial CMO” queries. Confirm whether the partner supports your target market filings and API manufacturer responsibilities end-to-end.

Biologics CDMO

Biologics partners need cell-line development, upstream/downstream scale-up, and viral clearance validation. Related searches such as “Biologics CDMO” and “U.S. CDMO companies” reflect sponsor demand for mammalian and microbial production at clinical and commercial scale.

Cell & gene therapy · mRNA

CGT CDMOs require segregated suites, viral vector or plasmid capacity, and autologous or allogeneic experience—matching listicle intent for “cell therapy CDMO list,” “viral vector CDMO,” and “mRNA CDMO.” Verify facility-level evidence, not marketing claims alone.

Cross-check establishment registration via FDA DECRS where applicable.

Development phase and manufacturing scale

Phase I sponsors often need flexible batch sizes, rapid tech transfer, and analytical method development under one roof. Phase III and commercial programs require demonstrated commercial batch records, stability data, and capacity reservations. Ask whether the CDMO runs dedicated vs multi-product suites, and whether fill-finish is in-house or subcontracted.

Tech transfer timelines typically span 6–18 months depending on complexity; early alignment on analytical comparability and PPQ strategy avoids late-stage surprises. Prefer partners with prior FDA or EMA inspection outcomes documented on official sites or in your quality audit.

GMP certifications, DMF/CEP, and HPAPI containment

Minimum diligence includes FDA-registered facilities for US-bound product, EU GMP compliance for EMA markets, and ISO 13485 where device-drug combinations apply. For APIs, confirm DMF or CEP status—navigational queries such as “DMF CEP API manufacturer directory” signal sponsor need for verifiable filing support, not directory copy.

HPAPI programs need containment validation (OEB bands), cross-contamination controls, and occupational safety programs. Request recent inspection classifications where publicly available and verify claims against primary registries.

Fill-finish, drug product, and integrated CDMO scope

Integrated CDMOs offer end-to-end paths from drug substance through sterile fill-finish and secondary packaging; functional models split API and drug product across vendors. Sterile fill-finish CDMO partners should specify vials, prefilled syringes, cartridges, lyophilization, and visual inspection under GMP.

Compare service tables on enriched profiles against your bill of materials. Packaging may also appear under cold chain and primary container suppliers.

Geography, supply chain, and dual sourcing

Site location affects lead times, import licenses, and geopolitical risk. Related searches such as “Pharma cdmo directory california” reflect regional sourcing—many sponsors dual-source API and drug product across US and EU sites. Evaluate cold-chain handoffs for biologics between campuses.

CDMO shortlisting checklist

  • Modality match (API, biologics, CGT/mRNA, fill-finish, HPAPI)
  • Phase-appropriate batch scale and suite availability
  • FDA/EU GMP evidence and inspection history
  • DMF/CEP or filing support for APIs
  • In-house fill-finish vs subcontractor transparency
  • HPAPI/containment tier if applicable
  • Analytical and stability capabilities
  • Tech transfer and PPQ track record
  • Geographic footprint (US/EU dual source)
  • Quality agreement and audit readiness

Editor's picks

Curated enriched profiles worth citing—selected for structured certifications, product data, and primary-source evidence, not paid placement.

  • Rentschler Biopharma:Representative biologics CDMO profile with GMP credentials, service scope, and structured certifications—useful for comparing mammalian production partners.
  • Cytiva:Bioprocess infrastructure and manufacturing technologies widely deployed across CDMO networks; strong reference for modality and scale-up discussions.

All CDMO & Manufacturing suppliers

4D Pharma

CRO & Clinical Services

4D Pharma is a clinical-stage biotech company developing live biotherapeutic products based on single bacterial strains identified via its MicroRx platform. It focuses on oncology, immune-mediated and CNS indications, offering specialized microbiome discovery and development capabilities for partners rather than general-purpose CDMO manufacturing.

ABITEC Corporation

Life Science Reagents

ABITEC Corporation is a global specialty lipid manufacturer supplying high-purity lipid-based excipients for pharmaceuticals, nutrition and specialty applications. Its ISO-certified, cGMP and IPEC-compliant facilities produce functional solubilizers, emulsifiers, surfactants and custom lipids, including brands such as Capmul®, Captex® and Nutri Sperse®, plus research-grade lipids via Larodan and custom chemistries for LNP therapeutics.

Acuitas Therapeutics

CDMO & Manufacturing

Acuitas Therapeutics is a private, Vancouver-based biotechnology company specializing in lipid nanoparticle (LNP) delivery systems for nucleic acid therapeutics. The company does not develop its own drugs, but partners with pharma, biotech, NGOs and academics to enable vaccines and gene and RNA therapies from preclinical stages through clinical development, regulatory approval and commercialization using its clinically validated LNP platforms.

Air Cylinders, Solenoid Valves and Pneumatics

CDMO & Manufacturing

SMC Corporation of America is a leading manufacturer of air cylinders, solenoid valves, pneumatics, vacuum products, electric actuators and utility management equipment used across automation and process industries. Its portfolio includes actuators, valves, sensors, industrial chillers, fluid and chemical handling components and cobot gripping solutions suitable for pharmaceutical labs and manufacturing environments.

Aldevron

CDMO & Manufacturing

Aldevron is a CDMO specializing in plasmid DNA, RNA, proteins and CRISPR tools for gene therapy, cell therapy, gene editing and RNA vaccines, offering both catalog products and custom manufacturing from research through commercial. With cGMP and GMP‑Source facilities in Fargo plus R&D and process development sites in Madison and Waltham, it provides integrated services including mRNA production, LNP encapsulation, fill/finish and robust regulatory support.

Alfa Chemistry

CRO & Clinical Services

Alfa Chemistry is an ISO 9001:2015–certified chemical supplier and CRO providing research chemicals, building blocks, APIs, materials, and custom synthesis and analytical services. Based in Holbrook, New York, it serves global pharma, biotech, materials science, and academic customers through a broad online catalog, custom chemistry projects, and 24/7 technical support. The company also offers storage solutions and extensive technical tools and resources for laboratory users.

AlphaLabs - AlphaLabs

CDMO & Manufacturing

Alpha Laboratories (AlphaLabs) is an Ontario-based diagnostics provider offering medical laboratory testing, diagnostic imaging, ECG and Holter monitoring, and specimen collection services, supported by patient and clinician portals. It also delivers raw material analysis, elemental analysis, and pharmaceutical product testing for manufacturers, operating state-of-the-art, accredited laboratories licensed by the Ontario Ministry of Health.

Animal-Free Egg Protein Supplier

Life Science Reagents

Onego Bio is a private precision-fermentation company supplying animal-free egg protein for food manufacturing. Its Bioalbumen® ingredient is positioned as a bioidentical ovalbumin alternative with FDA GRAS “no questions” status and functional performance for formulations that use egg white.

Applied StemCell

CRO & Clinical Services

Applied StemCell is a US-based genome engineering CRO/CDMO specializing in iPSC, CRISPR and TARGATT™-enabled cell line engineering, iPSC services, and cGMP cell banking. The company also offers GMP hiPSC products, TARGATT™ knock-in kits, and differentiated iPSC cells to support discovery through early GMP manufacturing for cell and gene therapy programs.

Aria Pharmaceuticals

CRO & Clinical Services

Aria Pharmaceuticals is a Palo Alto–based, preclinical-stage biopharmaceutical company focused on discovering and developing novel small-molecule therapies for complex and hard-to-treat diseases. Using computational and data-driven discovery, it builds a diversified preclinical pipeline and offers collaboration opportunities to biopharma and research partners seeking innovative early-stage small-molecule programs.

Arrayjet Ltd

Life Science Reagents

Arrayjet Ltd is a Scottish microarray technology company that supplies inkjet microarray instruments and outsourced microarray services for pharma, diagnostics, and life-science R&D. Its portfolio spans protein, DNA/RNA, small-molecule, RPPA, and multiplex diagnostic applications, with ISO 13485:2016-controlled manufacturing in Scotland.

Asahi Kasei Bioprocess

CRO & Clinical Services

Asahi Kasei Bioprocess, part of Asahi Kasei Life Science, provides virus removal filters, microfilters and downstream bioprocessing equipment to enhance safety and efficiency in biologics manufacturing. Its portfolio centers on Planova™ virus removal filters and BioOptimal™ microfilters, supporting purification, fluid management and pathogen safety for regulated biotherapeutics.

Asimov — Intelligent Design

CDMO & Manufacturing

Asimov is a Boston-based synthetic biology company that integrates engineered host cells, large genetic parts libraries, and cloud-based design software to program living cells for advanced therapeutics. Through its CHO Edge, LV Edge, AAV Edge, and RNA Edge platforms, Asimov supports both tool transfer to client labs and full-service development of commercial-grade cell lines and viral vector producers.

AtaiBeckley

CRO & Clinical Services

AtaiBeckley is a clinical-stage biopharmaceutical company formed in 2025 through the combination of atai Life Sciences and Beckley Psytech, focused on transformative mental health therapies. Its pipeline includes psychedelic-based and related neuroplastogen candidates such as BPL-003, VLS-01 and EMP-01 for treatment-resistant depression and social anxiety disorder, developed as rapid-acting, durable and convenient treatments.

Atara

CDMO & Manufacturing

Atara Biotherapeutics is a public, clinical-stage allogeneic T-cell immunotherapy company pioneering off-the-shelf EBV-based T-cell therapies for cancer and autoimmune diseases. It is the first company to gain approval for an allogeneic T-cell immunotherapy, EBVALLO™ (tabelecleucel), supported by a scalable, versatile platform capable of producing over a thousand doses from a single donor.

Autoimmune & Inflammatory Disease Therapeutics

CRO & Clinical Services

BioSenic SA is a Belgian, Euronext‑listed clinical-stage biotech company focused on regenerative and immune medicine for inflammatory diseases and bone disorders. Its portfolio includes ATO‑based systemic therapies, an orphan-designated ATMP cell therapy (ALLOB) for rare bone diseases, and injectable products for osteoarthritis and bone repair, supported by European public-company governance.

BOC Sciences

CRO & Clinical Services

BOC Sciences is a global custom lab chemical supplier and fermentation-focused CDMO providing high-purity small molecules, nucleosides, nucleotides and pharmaceutical impurities, along with custom synthesis, microbial fermentation and cGMP manufacturing. It serves pharma, biotech, agrochemical and RNA/mRNA therapeutic developers worldwide from early discovery through commercial-scale production.

Bio-Techne

Life Science Reagents

Bio-Techne Corporation is a public global life-sciences supplier headquartered in Minneapolis, Minnesota. It provides reagents, analytical instruments, precision diagnostics, GMP manufacturing, and testing services across research, translational, and clinical workflows.

Biochromato

CRO & Clinical Services

BioChromato is a Japanese manufacturer of innovative lab equipment and consumables that enhance research efficiency in chemical and analytical laboratories. Its Smart Evaporator systems, RAPID plate seals, and ionRocket DART-MS interface help pharma and biotech labs accelerate solvent evaporation, protect volatile samples, and analyze complex materials with minimal pre-processing.

Biohithealthcare

CDMO & Manufacturing

Biohit Oyj is a Finnish public biotech and diagnostics company focused on innovative gastrointestinal diagnostics and disease prevention. Headquartered in Helsinki with subsidiaries in Italy and the UK, Biohit offers test systems such as GastroPanel and rapid GI tests, alongside monoclonal antibodies for research and diagnostic industry use.

Biological raw materials- Logical Biological

CDMO & Manufacturing

Logical Biological is a UK-based supplier of human biological raw materials founded in 2019. Headquartered at Discovery Park in Sandwich, Kent, the company provides serum, plasma, urine, saliva, swabs, PBMCs, and tissue specimens for IVD control manufacturing and diagnostic research. ISO 9001:2015 certified and Human Tissue Act licensed.

Biologics CDMO & Protein Production

Life Science Reagents

Bionova Scientific is a private biologics CDMO in Fremont, California, focused on recombinant protein therapeutics, mAbs, and therapeutic proteins. It offers development through GMP manufacturing services, including cell line development, process development, analytical support, and clinical/commercial biologics production.

Biopreservation Platform for Organs & Cell Therapies

CDMO & Manufacturing

X‑Therma is a private biotechnology company in Hercules, California, specializing in DMSO‑free, peptoid‑based biopreservation solutions for cells, tissues and organs. Its XT‑Thrive®, XT‑ViVo®, XT‑NoVo® and TimeSeal® platforms enable multi‑day, sub‑zero preservation and transport, including an FDA Breakthrough Device‑designated system for kidney storage up to 120 hours, serving organ transplantation, cell and gene therapy, and IVF markets.

Biosynth

Life Science Reagents

Biosynth AG is a Switzerland-headquartered global supplier of life sciences reagents and CDMO services, offering carbohydrates, nucleosides, enzyme substrates, peptides, antibodies and diagnostic materials alongside custom synthesis, GMP manufacturing and biologics development under ISO 9001 and cGMP standards. The KKR and Ampersand-owned company operates 15 facilities across three continents.

Frequently asked questions

What is a CDMO in biopharma?
A CDMO (contract development and manufacturing organization) provides outsourced drug development and GMP manufacturing for biopharma sponsors—from process development through commercial supply of drug substance and drug product.
What is CMO in contract manufacturing?
A CMO (contract manufacturing organization) performs GMP manufacturing for a sponsor under contract, often for a defined process or product. A CDMO adds development services such as formulation, analytical methods, and tech transfer before manufacturing.
What is API in GMP?
API (active pharmaceutical ingredient) is the therapeutically active component of a drug product. Under GMP, API manufacturing must follow validated processes, impurity controls, and regulatory filing support (e.g., DMF or CEP) appropriate to the target market.
What is the difference between a CMO and a CDMO?
A CMO typically focuses on manufacturing; a CDMO also provides development services such as formulation, analytical method development, and tech transfer. Many sponsor RFPs use the terms interchangeably—verify scope in the quality agreement.
What does an API manufacturer do?
An API manufacturer synthesizes or biologically produces the active ingredient, validates the process under GMP, and supports regulatory filings. Sponsors may use an API CDMO for clinical batches through commercial supply or split API and drug product across vendors.
What are the top cell therapy CDMOs?
Rankings vary by modality (autologous vs allogeneic), vector type, and geography. Use this directory to compare verified CGT and viral vector capabilities on enriched profiles, then validate capacity and inspection history through audits—not third-party listicles alone.
Where can I find a list of CDMO companies?
This category hub indexes published CDMO and manufacturing suppliers with structured GMP credentials, services, and sources. Filter by modality using the browse row above, then open individual profiles before issuing an RFP.
Is this a free pharma CDMO directory?
Yes—NovaPharmaNews publishes this open supplier directory with editorial buyer guides and enriched profiles. We do not charge suppliers for basic listings; profiles are compiled from official websites and public regulatory sources.
What is fill-finish CDMO services?
Fill-finish CDMOs perform sterile drug product filling, lyophilization where required, stoppering, crimping, and visual inspection under GMP—often the final step before labeled commercial supply.
What is HPAPI manufacturing?
HPAPI (highly potent API) manufacturing requires specialized containment, cleaning validation, and occupational exposure limits. CDMOs disclose OEB bands and dedicated suite strategies for cytotoxic or hormone APIs.
How do I choose a CDMO for Phase III?
Prioritize commercial-scale capacity, PPQ experience, regulatory inspection history, and stability/comparability data. Confirm fill-finish and packaging are qualified for your presentation and that the CDMO can support concurrent US and EU filings if needed.
How are suppliers in this CDMO directory curated?
Profiles are enriched from official company websites and public regulatory sources, with quality gates before publication. See our data sources and methodology page for details.

Last reviewed: · Data sources & methodology

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