CDMOs in North America

With more than 30 years of CDMO experience, Ferndale Labs CDMO supports pharmaceutical and healthcare companies developing and manufacturing liquid and semi-solid drug products. Our FDA-registered facility specializes in semi-solid and liquid formulations, including creams, gels, lotions, ointments, suspensions and solutions for Rx, OTC, and medical device applications. Built on agility, flexibility, and versatility, Ferndale helps partners advance programs from development through clinical supply and commercial manufacturing.

ResolveMass Laboratories Inc. is a Canadian pharmaceutical CRO and CDMO providing analytical testing, characterization, and drug development support for pharmaceutical, biotechnology, and medical device companies worldwide. Our expertise spans small molecules, peptides, biologics, biosimilars, oligonucleotides, polymers, and complex drug products. We offer specialized services including mass spectrometry (LC-MS/MS, LC-HRMS), peptide characterization, impurity identification, nitrosamine analysis, extractables and leachables (E&L) studies, bioanalytical testing, stability studies, method development, and regulatory support. Our multidisciplinary scientific team helps clients address complex analytical challenges and generate high-quality data to support research, development, manufacturing, and regulatory submissions. ResolveMass Laboratories operates from Canada and serves clients across North America, Europe, and Asia. The company maintains an ISO 9001:2015 certified Quality Management System, is FDA-registered, and holds a Health Canada Drug Establishment Licence for GMP-compliant operations. We are committed to delivering scientifically rigorous, reliable, and timely solutions that accelerate drug development and support regulatory success.

Abzena

United States

Abzena is a leading complex biologics and bioconjugates CDMO+CRO headquartered in the UK with 20+ years of experience. They provide fully integrated services from antibody discovery through commercial GMP manufacturing, specializing in ADCs, AOCs, RDCs, mAbs, fusion proteins, and bispecifics. With over 1,400 lead candidates discovered, 100+ production cell lines developed, and 2,000+ bioconjugates produced, they operate state-of-the-art facilities in San Diego, Bristol (PA), and Cambridge (UK).

ACIC Pharmaceuticals Inc

Canada

ACIC Pharmaceuticals Inc is a CDMO headquartered in Coral Springs, Florida, providing integrated pharmaceutical solutions from molecule to market. They offer API manufacturing, CDMO services for complex injectables including long-acting and cytotoxic injectables, regulatory support, and pharmaceutical equipment solutions. They have 249 FDA-approved products across a wide range of dosage forms.

AGC (AGC Biologics & AGC Pharma Chemicals)

United States

AGC Biologics is a leading global CDMO providing contract development and manufacturing services for biologics, cell and gene therapies, and advanced modalities. With facilities in Seattle, Copenhagen, Heidelberg, Milan, Chiba, and Yokohama, AGC operates mammalian and microbial expression systems and offers end-to-end services from process development through commercial-scale manufacturing.

Agilent Advanced Therapeutics

United States

BioVectra is a Canadian full-service CDMO specializing in biologics, small molecules, nucleic acids, and fill/finish, now a part of Agilent Technologies. With over 50 years of pharmaceutical manufacturing experience, the company leverages microbial fermentation expertise and complex chemistry to support partners from clinical to commercial stage. BioVectra operates multiple manufacturing facilities in Canada and recently opened a 36,000 sq ft mRNA facility as part of a $90M expansion in Charlottetown.

Agno Pharmaceuticals

United States

Agno Pharmaceuticals is a U.S.-headquartered global end-to-end CDMO providing comprehensive solutions from API development and intermediates through complex drug product formulation to cGMP manufacturing for both clinical trials and commercial production. The company supports both innovative and generic pharmaceutical sectors with capabilities in small molecule APIs, highly potent APIs (HPAPIs), sterile APIs, and drug products.

ApiJect Systems

United States

ApiJect Systems is a U.S.-based medical technology company that manufactures prefilled injectors using Blow-Fill-Seal (BFS) technology. They are opening an FDA-registered 503B outsourcing facility in Apex, NC to produce generic injectable medicines. They combine BFS containers with pen needle hubs to create prefilled injection devices, focusing on reshoring essential drug manufacturing and addressing drug shortages.

Apotex (incl. Apotex Pharmachem)

Canada

Apotex is Canada's largest pharmaceutical company with global operations spanning API manufacturing, finished dosage form production, and CDMO/co-development services. With capacity to produce approximately 25 billion finished doses annually and three API manufacturing sites, they serve both their own generic portfolio and external partners through Apotex Pharmachem (API CDMO) and Apotex Fermentation (fermentation-based manufacturing).

Aprecia Pharmaceuticals

United States

Aprecia Pharmaceuticals is a Cincinnati-based CDMO that pioneered the use of 3D printing (binder jet 3DP) technology for pharmaceutical manufacturing. Their proprietary ZipDose technology platform produces rapidly disintegrating oral solid dosage forms. They hold FDA-registered facilities with operations spanning analysis, API manufacture, labeling, manufacturing, and packaging. They have FDA-approved products including tablets and oral suspensions.

Ascendia Pharmaceutical Solution

United States

Ascendia Pharmaceutical Solutions is a CDMO specializing in formulation development and cGMP manufacturing of drug products. Known for novel enabling technologies such as NanoSol (nanoparticle), AmorSol (amorphous solid dispersion), EmulSol (nano-emulsion), and LipidSol (lipid nanoparticle), they help partners advance poorly soluble compounds from pre-formulation through commercialization.

AtomVie Global Radiopharma Inc.

Canada

AtomVie Global Radiopharma Inc. is a leading radiopharmaceutical CDMO dedicated to cGMP manufacturing and global distribution of radiopharmaceuticals. They specialize in radiolabeling with isotopes including Lu-177, Ac-225, I-131, In-111, Zr-89, and Tb-161. They have delivered 3,000+ doses to 26 countries with >99% accuracy. Their new 72,300 sq ft Hamilton, Ontario facility (opening 2026) will have 18+ production lines and 10x current capacity. Clients include Radiopharm Theranostics, Cellectar, and POINT Biopharma.

Avid Bioservices, Inc.

United States

Avid Bioservices, Inc. is a dedicated biologics CDMO based in Costa Mesa, California, with 30+ years of experience in mammalian cell culture-based biologics manufacturing. The company provides end-to-end drug substance and drug product services for monoclonal antibodies, bispecific antibodies, enzymes, and recombinant proteins. Avid operates from its main facility plus a new 78,000 sq ft Early Phase Center of Excellence (opened February 2026) for early-stage development. Services include cell line development, process development, analytical method development, cGMP manufacturing, and late-stage clinical and commercial biologics production. Avid has built a track record as one of the few US-based pure-play biologics CDMOs.

Avrio Biopharma (Avrio Biopharmaceuticals, LLC)

United States

Avrio Biopharmaceuticals LLC is a US-based CDMO operating a cGMP facility focused on clinical trial services, formulation development, aseptic fill and finish, lyophilization, CMC support, and packaging and labeling. They offer comprehensive pre-formulation services, parenteral and solid/semisolid/liquid dosage form development, lyophilization cycle development, ophthalmics, emulsions, suspensions, and liposome/microsphere encapsulation. The company also provides clinical trial management, regulatory submissions support, and has received California Drug Manufacturing and Medical Device Manufacturing licenses. Their product portfolio includes generic formulations of gabapentin, pregabalin, and modafinil.

Axcellerate Pharma LLC

United States

Axcellerate Pharma LLC is an award-winning CDMO based in Piscataway, New Jersey, providing CRO and CDMO services for both large and small molecules. Their capabilities span cGMP API manufacturing (small molecules), sterile aseptic filling (vials, syringes, cartridges, bags), lyophilization, mammalian cell culture, microbial fermentation, oligonucleotide synthesis, PEGylation, and commercial manufacturing including generics, controlled substances, hormones/steroids, and cytotoxic/oncology compounds. The company operates from a multi-faceted facility that includes ISO Class 5-8 sterile areas, dedicated process areas for biologics development, chemical development, and sterile manufacturing.

Bend Bioscience Inc.

United States

Bend Bioscience (formed from CoreRx, Societal CDMO, and other specialist CDMOs) is a U.S.-based small molecule pharmaceutical CDMO offering end-to-end development and manufacturing from pre-clinical to commercial scale. They specialize in oral bioavailability enhancement via spray dried dispersions, particle engineering, multiparticulates, and modified release technologies. They operate FDA, EMA, ANVISA, and DEA-inspected facilities across three U.S. locations (Oregon, Georgia, Florida) with capabilities spanning oral solids, liquids, topicals, and powders for inhalation.

Benuvia Operations, LLC

United States

Benuvia Operations, LLC is a US-based specialized CDMO and API supplier focused on controlled substances. They pioneer work with cannabinoids, psychedelics, and traditional pharmaceuticals, offering a unified services platform from IND-enabling through commercial manufacturing. They hold DEA registrations and are FDA-registered for API manufacture, analysis, labeling, manufacturing, and packing. Their SYNDROS (Dronabinol) CII product demonstrates their controlled substance expertise.

Bionova Scientific

United States

Bionova Scientific is a US-based biologics CDMO (part of Asahi Kasei Group) focused on the development and GMP manufacturing of monoclonal antibodies and other therapeutic proteins using mammalian cell culture processes. They offer cell line development, upstream/downstream process development, formulation development, pilot production, GMP manufacturing, and process characterization. Expanding into plasmid DNA (pDNA) manufacturing with a new facility in The Woodlands, Texas.

BioTechnique LLC

United States

BioTechnique LLC is a full-service CRDMO based in York County, Pennsylvania, specializing in cytotoxic and therapeutic sterile injectable fill-finish services. The company provides services from investigational/clinical through to final marketed products, handling both small and large batch sizes. BioTechnique operates an FDA-registered facility with capabilities spanning sterile manufacturing, lyophilization, and high-potency compound handling.

Bora Biologics

United States

Bora Biologics is a biologics-focused CDMO based in the United States offering contract development and manufacturing services for monoclonal antibodies, recombinant proteins, and other biologic drug substances and drug products. The company provides end-to-end biologics services from cell line development through cGMP manufacturing, analytical testing, and aseptic fill/finish.

Bora Pharmaceutical

Canada

Bora Pharmaceuticals is a global CDMO headquartered in Canada with manufacturing facilities across North America and Asia. The company offers comprehensive contract development and manufacturing services for oral solid dosages, sterile injectables, topicals, and liquids, serving both clinical and commercial supply needs with FDA and EMA approved facilities.

Boston Institute of Biotechnology (BIB)

United States

Boston Institute of Biotechnology (BIB) is a US-based full-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy services. The company features the world's first ultra-large bioreactor with 30,000L working volume capacity and provides end-to-end services from cell line development through commercial-scale cGMP manufacturing.

Bryllan

United States

Bryllan is a US-based CDMO specializing in the production and filling of potent and cytotoxic compounds, with a focus on aseptic powder and liquid filling for complex drug and device combination products. The company operates a high-containment, state-of-the-art facility in Brighton, Michigan, supporting both clinical and commercial supply of ADCs and other cytotoxic products.

Cambrex

Canada

Halo Pharmaceuticals, acquired by Cambrex in 2018 for $425 million and later sold to SK Capital Partners in 2023, is a drug product CDMO specializing in oral solids, liquids, creams, sterile and non-sterile ointments, complex formulations, pediatric indications, and controlled substances. The company operates 430,000 square feet of GMP-compliant manufacturing space across Whippany, New Jersey and Montreal, Quebec, serving over 85 clients.

Catachem, Inc.

United States

Catachem, Inc. is a U.S.-based, ISO 13485-certified and FDA-registered manufacturing company headquartered in Oxford, Connecticut, specializing in enzyme-based chemistries, custom reagent solutions, and lyophilization services. The company provides contract development and manufacturing services to the medical device, pharmaceutical, and biotechnology industries. They are targeting cGMP compliance by July 2026.

Continuus Pharmaceuticals

United States

Continuus Pharmaceuticals is a pioneering CDMO based in Woburn, Massachusetts, specializing in Integrated Continuous Manufacturing (ICM) technology for small-molecule pharmaceuticals. The company replaces traditional batch processes with end-to-end continuous manufacturing, transforming raw materials into APIs and finished dosage forms in days rather than months. Continuus has received FDA and BARDA partnerships and a $69.3M DoD grant, and is building a $125 million manufacturing facility in Woburn.

Contract Pharmaceuticals Ltd (CPL)

Canada

Contract Pharmaceuticals Limited (CPL) is a Canadian CDMO specializing in non-sterile liquid and semi-solid pharmaceutical products from concept to commercialization. The company offers end-to-end solutions including product development (NDAs, ANDAs, OTCs), commercial manufacturing, filling, packaging, and testing for creams, ointments, gels, lotions, nasal sprays, and liquid formulations. CPL's facilities are FDA and Health Canada registered, and have been inspected by the Japanese Health Authority, with Mutual Recognition Agreements covering the EU and Australia.

CreoSalus

United States

CreoSalus Inc. is a Louisville, KY-based cGMP CDMO specializing in custom peptide synthesis, process development, and manufacturing of peptide drug substances (API) and sterile injection drug products. The company has pioneered personalized peptide cancer vaccine manufacturing since 2016, producing thousands of personalized peptide vaccines for clinical trials with a 100% patient order success rate.

Emergent BioSolutions

Canada

Emergent BioSolutions is a specialty life sciences company with CDMO capabilities, though it has been actively pivoting away from its CDMO business. The company has sold its Baltimore-Bayview drug substance facility to Syngene and its Baltimore-Camden sterile fill/finish facility to Bora Pharmaceuticals. Emergent retains four manufacturing facilities across North America (US and Canada) and holds FDA registrations, 6 approved products, and has conducted 5 clinical trials in infectious disease. The company previously invested $75M in viral vector and gene therapy capabilities at its Canton site.

JAMP Pharma

Canada

JAMP Pharma Group is a leading Canadian pharmaceutical company with over 35 years in the industry, active across generic drugs (JAMP Pharma), biosimilars (BioJAMP), branded products (Orimed Pharma), natural health products (Wampole/Laboratoire Suisse), and beauty products (Cosmetic Import). The company acquired a pharmaceutical manufacturing facility in Levis, Quebec, and manufactures prescription drugs in Canada through its JAMP Pharma Manufacturing division.

Jerome Stevens Pharmaceuticals, Inc.

United States

Jerome Stevens Pharmaceuticals, Inc. (JSP) is a family-owned pharmaceutical manufacturer based in Bohemia, New York, established in 1979. The company specializes in manufacturing prescription tablet and capsule formulations under cGMP standards. JSP is notable for manufacturing UNITHROID, the first FDA-approved Levothyroxine Sodium product, and also produces Digoxin tablets. The company provides CMO services to partners including Amneal Pharmaceuticals.

Nephron

United States

Nephron Pharmaceuticals is a US-based sterile pharmaceutical manufacturer and 503B outsourcing facility headquartered in West Columbia, South Carolina. The company specializes in generic respiratory medications (inhalation solutions and suspensions) and contract manufacturing of sterile pre-filled medications using blow-fill-seal (BFS) technology, producing over one billion doses annually.

NorthStar Medical Radioisotopes, LLC

United States

NorthStar Medical Radioisotopes is a US-based commercial-stage company focused on the development, production, and commercialization of radiopharmaceuticals. Operating a dedicated Radiopharmaceutical CDMO/CMO on its 55-acre Beloit, Wisconsin campus, NorthStar develops novel non-reactor-based production processes for therapeutic and diagnostic radioisotopes including Molybdenum-99, Copper-67, and Actinium-225. The company has 14 FDA-approved products and a 52,000 sq ft purpose-built CDMO facility.

Novocol Pharma

Canada

Novocol Pharma is a CDMO headquartered in Cambridge, Ontario, Canada, specializing in sterile injectable fill-finish and combination drug product assembly. With over 40 years of experience, the company offers aseptic and terminally sterilized manufacturing from development through commercialization. Novocol Pharma is a Septodont company and has a fill-finish partnership with Moderna for mRNA vaccines.

Nucleus RadioPharma

United States

Nucleus RadioPharma is a US-based full-service CDMO dedicated to building clinical and commercial supply chains for targeted radiotherapies (radiopharmaceuticals). The company operates a cGMP-compliant facility in Rochester, MN with expansion sites under construction in Spring House, PA and Mesa, AZ, targeting over 100,000 square feet of purpose-built radiopharmaceutical development and manufacturing space.

Pace® Life Sciences

United States

DUPLICATE ENTRY -- This is the same company as 'Pace Analytical Services LLC (Pace Life Sciences)' (company index 10). Pace Life Sciences is the CDMO/CRO division of Pace Analytical. Same website content, same capabilities. See company index 10 for full profile.

Padagis LLC

United States

Padagis LLC is a U.S.-based generic pharmaceutical company specializing in development and manufacturing of extended topical and specialty pharmaceutical products. Product portfolio includes prescription creams, ointments, gels, foams, sprays, patches, nasal treatments, and suppositories, with a focus on Paragraph IV generic products. Also manufactures naloxone nasal spray (awarded New York State Department of Health contract in 2025). Over 1,300 employees. Offers contract manufacturing, licensing, and joint venture partnerships.

Pharmascience

Canada

Pharmascience is Canada's largest privately-owned pharmaceutical company, a leading manufacturer of generic, branded, and over-the-counter pharmaceuticals. The company has recently expanded its CDMO services with a new commercial business unit, investing over $120 million to expand its sterile injectable manufacturing facility in Candiac, Quebec, aiming to more than triple capacity. Pharmascience's ambition is to become a world leader in the sterile injectable CDMO segment. The company distributes products in over 50 countries and invests approximately $65 million per year in R&D in Canada. The Pendopharm division offers specialty medicines in gastroenterology, orthopedics, and neurology.

Pharma Tech Industries

United States

Pharma Tech Industries (PTI) is a pharmaceutical CDMO specializing exclusively in non-sterile dry powder blending and high-speed packaging. Founded in 1972, the company operates multiple FDA-registered, NSF-compliant, climate-controlled facilities in Georgia and Missouri under strict cGMP standards. PTI provides development to high-volume commercial-scale production for pharmaceutical, OTC drug & personal care, and nutritional health & medical foods. Delivery formats include sachets, stick packs, bottles, pouches, effervescents, tablets, capsules, drug-devices, and medical swabs. The company has onsite GMP analytical/microbiology labs and uses quality systems including Empower, eQMS, EDMS, and ERP Serialization. PTI earned the highest possible score in the 2024 CDP SME environmental evaluation.

Phlow Corporation

United States

Phlow Corporation is a U.S.-based public-benefit pharmaceutical manufacturer specializing in onshore continuous-flow production of medicines and APIs. The company was awarded a landmark $354 million HHS/ASPR/BARDA contract to manufacture essential medicines in shortage, strengthening America's pharmaceutical supply chain. Phlow has raised $37 million in Series C funding to expand U.S.-based CDMO operations. The company partners with Fresenius Kabi for the first-ever end-to-end U.S. manufacturing of Epinephrine Injection USP, with Antheia for advanced manufacturing technologies, and with USP for pharmaceutical continuous manufacturing. Phlow is driving sustainable cost competitiveness through advanced manufacturing technology including continuous flow chemistry and AI-enhanced analytics.

Pillar5 Pharma Inc.

Canada

Pillar5 Pharma is a Canadian CDMO founded in 2009, specializing in sterile ophthalmic manufacturing and solid dose production. Market leader in Multi-Dose Preservative Free (MDPF) technology in North America. Produces 30 million ophthalmic bottles and 255 million solid dose tablets per year with 210+ employees. Acquired by ANJAC Sante & Beaute and is also a Prestige Consumer Healthcare company. Health Canada approved, holds FDA Drug Establishment Registration. Acquired former Pfizer site in Arnprior, Ontario.

Profacgen

United States

Profacgen is a US-based protein services and biologics CDMO headquartered in Shirley, New York. The company provides custom protein expression, protein analysis, drug development services, and cGMP-compliant biopharmaceutical manufacturing from a 25,000 sq ft GMP and GLP-compliant facility. Profacgen offers end-to-end CDMO support for biologics including feasibility assessment, process development, cGMP manufacturing, and regulatory filing support.

ProMed Pharma

United States

ProMed Pharma is a US-based CDMO specializing in long-acting injectable and implantable dosage forms with nearly 20 years of operational history. The company has mastered polymer-based drug delivery including molding, extrusion, and microencapsulation techniques using silicones, thermoplastics, and biodegradable excipients. ProMed supports projects from early-stage feasibility through commercial manufacturing and has expanded with the acquisition of a 28,000 sq ft facility in Plymouth, Minnesota.

Pyramid Laboratories

United States

Pyramid Laboratories (now Pyramid Pharma Services) is a California-based CDMO established in 1988, specializing in aseptic manufacturing, development, and analytical services for parenteral drugs. The company supports biologics, peptide, and small molecule drugs from pre-clinical development through commercial supply. Pyramid operates a 90,000 sq ft GMP-compliant facility in Costa Mesa, California, and has received investment from Audax Private Equity.

Renaissance Lakewood, LLC

United States

Renaissance Lakewood is a US-based pure-play CDMO specializing in nasal spray and sterile injectable dosage forms. Founded in 1979 (originally Paco Packaging Labs), they have nearly 20 years of nasal spray experience and offer bench-to-shelf services including formulation development, spray characterization, clinical through commercial manufacturing. Recently acquired by LTS Lohmann Therapie-Systeme AG to expand LTS's CDMO capabilities. FDA-registered with manufacturing, analysis, labeling, and packaging operations in Lakewood, NJ. They have invested over $100M in facility improvements over the past five years.

Sofgen Pharmaceuticals

United States

Sofgen Pharmaceuticals, part of Procaps Group, is an integrated softgel CDMO that offers end-to-end solutions in softgel technologies from development through delivery. The company serves pharmaceutical, OTC, and nutraceutical customers, with operations across 13 countries in the Americas and customers in 50+ countries.

SOFIE

United States

SOFIE (formerly SOFIE Biosciences) is a U.S.-based radiopharmaceutical company that develops, manufactures, and distributes PET imaging agents and theranostic radiopharmaceuticals. The company operates 14 network pharmacy sites and a Theranostics Center of Excellence in Totowa, NJ. SOFIE offers contract manufacturing services for radiopharmaceuticals under 21 CFR 211 and 212 cGMP standards.

Stira Pharmaceuticals (Sterile Injectable CDMO)

United States

Stira Pharmaceuticals is a U.S.-based CDMO specializing in the development and cGMP manufacture of complex sterile injectable products, with integrated analytical capabilities. Founded in 2019, the company serves the U.S. market with services spanning small molecules, peptides, oligonucleotides, and biosimilars in formats including vials, syringes, IV bags, and cartridges with batch sizes up to 2,000L.