Affinity Life Sciences provides custom lyophilization, manufacturing, and formulation services from its cGMP compliant facility. They specialize in cycle development and production for the diagnostics, medical device, and pharmaceutical industries, including cell culture services for recombinant proteins and monoclonal antibodies.
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Pharmaceutical Contract Manufacturers
Last updated: January 2026
This directory lists 94 pharmaceutical contract manufacturers across the United States, from early-stage development CDMOs (Contract Development and Manufacturing Organizations) specializing in formulation and analytical method development, to large-scale commercial manufacturers offering high-volume aseptic fill-finish capabilities.
Buyers engage these specialized partners to solve complex problems such as scaling up production from clinical batches to commercial volumes, ensuring consistent product quality through rigorous process validation, managing intricate global supply chains for Active Pharmaceutical Ingredients (APIs), and executing comprehensive stability studies for shelf-life determination. The breadth of services often extends to regulatory affairs support, including compiling Chemistry, Manufacturing, and Controls (CMC) sections for regulatory filings and managing serialization requirements for global markets.
The types of pharmaceutical contract manufacturers vary significantly by their core competencies. Some operate as full-service CDMOs, providing end-to-end development, clinical trial material production, and commercial manufacturing. Others function as pure Contract Manufacturing Organizations (CMOs), focusing primarily on executing established manufacturing processes. Specialized facilities cater to specific needs, such as sterile injectables, highly potent compounds, controlled substances requiring DEA registration, or advanced biologics, each demanding distinct infrastructure, containment strategies, and regulatory expertise.
Company Directory
94 companies nationwide
Based in Charlottesville, VA, Afton Scientific provides comprehensive aseptic manufacturing and fill-finish services for pharmaceutical biologics and small molecules. They offer contract manufacturing, sterile filling, and robust quality assurance. With FDA-inspected facilities, they ensure product integrity and regulatory compliance.
Based in Bothell, WA, AGC Biologics is a global CDMO providing development and manufacturing services for protein-based biologics and advanced therapies. The company specializes in cell therapy, viral vectors, microbial production, and antibody drug conjugates, guiding projects from early development through GMP manufacturing.
Based in Everett, WA, Altasciences is an early phase contract research organization. They provide pharmaceutical contract manufacturing and analytical services, including formulation development and support for projects from Phase I through large-scale commercial production. Altasciences also offers preclinical safety testing, clinical pharmacology (Phase I-II), and bioanalysis.
American Injectables is an FDA-approved Contract Development and Manufacturing Organization (CDMO) based in Brooksville, FL. They specialize in sterile injectable pharmaceutical manufacturing, offering end-to-end solutions from formulation to patient-ready parenteral drugs. The company provides GMP fill-finish services with flexible batch sizes for vials and syringes.
Aphena Pharma Solutions provides contract pharmaceutical manufacturing and packaging services from its FDA-registered facilities in the U.S. The company offers turnkey solutions for solid dose, liquids, gels, creams, ointments, and other forms. They serve the prescription pharmaceutical, OTC, dietary supplement, consumer health, medical device, and biologics marketplaces.
Based in Mason, OH, Aprecia Pharmaceuticals specializes in advanced 3D printing (3DP) manufacturing for the pharmaceutical industry. They provide novel formulation and oral drug delivery solutions, supporting projects from clinical trial supply to commercial-scale production. The company operates a cGMP compliant, FDA inspected facility.
Attwill Medical Solutions, based in Lodi, WI, specializes in advanced CDMO services, including contract manufacturing of lyophilization for pharmaceutical intermediates, medical devices, and nutritional ingredients. The company offers services from formulation to finishing, contributing to the domestic supply chain for critical healthcare technologies.
Avara Pharmaceutical Services, Inc. is a pharmaceutical contract manufacturing organization with facilities in Puerto Rico and Oklahoma. They offer sterile fill-finish for liquid and lyophilized products, oral solid dosage forms (including potent compounds), process development, analytical support, and integrated packaging.
Based in Irvine, CA, Nitto Avecia Pharma Services offers comprehensive pharmaceutical contract manufacturing and development solutions. The company provides expert CMC services, including analytical chemistry, method development, and testing for gene therapy. Key capabilities include cGMP aseptic fill-finish, lyophilization, terminal sterilization, and parenteral manufacturing.
Based in Irvine, CA, Avrio Biopharmaceuticals, LLC provides pharmaceutical contract manufacturing services from its state-of-the-art cGMP facility. Capabilities include formulation development, aseptic fill and finish, lyophilization, and comprehensive packaging and labeling. They also offer clinical trial support.
Based in Round Rock, TX, Benuvia is a specialized CDMO and API supplier. They focus on controlled substances, cannabinoids, psychedelics, and traditional pharmaceuticals. The company provides advanced manufacturing practices, API and formulation development, regulatory services, and stability testing, supporting drug products from discovery through market advancement.
Bora Biologics is a technology-driven Contract Development and Manufacturing Organization (CDMO) specializing in mammalian and microbial development and manufacturing. They advance biologics from development to commercialization with speed and precision. The company operates an FDA registered facility in San Diego, CA, focusing on late-stage production and clinical to commercial scale manufacturing.
Based in Carlsbad, CA, Biopharma Technology LLC is a CDMO expert specializing in lyophilized products and liquid formulations. The company offers proven contract development and manufacturing services, leveraging over 35 years of experience in freeze-drying technology for pharmaceutical applications.
Based in Sayreville, NJ, Chemo Dynamics is a contract research and manufacturing organization (CDMO) for small molecules. They offer custom R&D, process research, and cGMP manufacturing services. Capabilities include multi-step synthesis and hydrogenation, utilizing GMP and non-GMP labs with reactors up to 200L.
Based in Solon, OH, CMC Pharmaceuticals, Inc. provides pharmaceutical formulation development and CMC services. Offerings include pre-formulation, analytical development, drug delivery system design, and prototype preparation. They also handle GMP manufacturing oversight for oral tablets, capsules, sterile injectables, and complex drug delivery systems.
CPC provides contract manufacturing and pharmaceutical development services. With over five decades of experience, the company is dedicated to establishing and raising industry standards. It focuses on comprehensive solutions for the pharmaceutical sector, driven by a mission of innovation and quality.
Based in Pleasanton, CA, Crystal PharmaTech is a specialized Contract Research and Development Manufacturing Organization (CDMO). The company focuses on crystal form and formulation, providing solid-state CRO services for small molecule drug development. They offer expertise from API form selection to clinical supply.
Based in Plantation, FL, GBI is a full-service biopharmaceutical CDMO providing cGMP-compliant aseptic fill and finish services for biologics and advanced therapeutics. They offer comprehensive support including manufacturing strategy, project management, regulatory and CMC assistance, and quality assurance, aiming to reduce client manufacturing risk.
Based in San Antonio, TX, Germaine Laboratories, Inc. is an FDA-registered and ISO 13485 certified manufacturing facility. The company provides small-scale, personal contract tableting services with full development support for various customers. They also offer reliable diagnostic testing supplies for the medical, drug testing, veterinary, and food & beverage industries.
Based in Livermore, CA, HTD Biosystems is a contract laboratory specializing in biopharmaceutical development. The company provides custom lyophilization services, protein and antibody characterization, and GLP Tox Lot Manufacturing. They assist in accelerating the development of biotech drugs, vaccines, and liposomal delivery systems for clients.
JOINN Bio is a global multi-site biologics CDMO providing comprehensive development and manufacturing services. Based in California, it offers cell line and process development, analytical assay development, formulation development, and cGMP manufacturing. The company specializes in upstream, downstream, and fill and finish operations for complex biologics.
KBI Biopharma Inc. is a global contract development and manufacturing organization (CDMO) specializing in biopharmaceutical development and manufacturing. They provide innovative biologic solutions, offering comprehensive services for new biologics including cell line, process, analytical, and formulation development across mammalian and microbial systems.
Kindeva is a drug delivery CDMO based in Woodbury, MN, specializing in injectable, inhalation, and dermal expertise. The company offers innovative CDMO solutions from development through commercial manufacturing, utilizing its facilities with aseptic operations space and fill suites for client projects.
Based in San Diego, CA, LATITUDE Pharmaceuticals Inc. offers GLP and GMP compliant manufacturing and analytical testing services. They specialize in complex drug formulation challenges, providing support from development through clinical trial material manufacture, GMP release testing, and sterile fill-finish. They also utilize CLEARSOL™ for difficult APIs.
Based in Boca Raton, FL, LGM Pharma specializes in sourcing Active Pharmaceutical Ingredients (APIs) and manufacturing drug products. The company serves numerous clients across diverse dosage systems, providing comprehensive services for pharmaceutical production.
Matica Biotechnology is a viral vector and gene therapy Contract Development and Manufacturing Organization (CDMO). Utilizing advanced technologies at its purpose-built cGMP facility, it offers end-to-end solutions for advanced therapy manufacturing, encompassing cell line development, process development, GMP production, and QC testing.
Based in Santa Ana, CA, McGuff Pharmaceuticals, Inc. is an FDA-inspected sterile liquid fill manufacturer. They offer cGMP-compliant pharmaceutical contract manufacturing services for brand and generic drug products, along with clinical trial materials. Services include R&D, product development, formulation, stability, and regulatory compliance, assisting sponsor companies leveraging their facilities and expertise.
Nivagen Pharmaceuticals, based in Sacramento, CA, develops, manufactures, and markets generic and specialty sterile injectable drugs. The company offers 505(b)(2) and 503B compounding services, utilizing its c-GMP sterile manufacturing facility for IV bags, vials, and cartridges. Nivagen is actively expanding its comprehensive CDMO services for pharmaceutical contract manufacturing.
Based in Oakwood Village, OH, Oakwood Labs is a pharmaceutical contract manufacturing organization with 28 years of industry experience. They offer full capabilities from R&D through GMP, specializing in over 100 long-acting injectable projects. The company utilizes a patent-protected manufacturing process for its clients.
Based in Sugar Land, TX, QuVa Pharma, Inc. provides outsourced sterile pharmaceutical manufacturing services. The company operates four FDA-compliant 503B facilities totaling 300,000 sq ft across Texas and New Jersey, specializing in solutions like del Nido Cardioplegia. It supports health-system pharmacies.
PCI Pharma Services is a CDMO providing integrated, end-to-end drug development, manufacturing, and packaging solutions. They specialize in advanced drug delivery, drug-device combination products, and sterile fill-finish and lyophilization manufacturing. The company focuses on accelerating drug products from development to commercialization.
Pii, A Jabil Company, provides end-to-end CDMO services, specializing in complex drug product formulation and manufacturing challenges. With over 30 years of experience, the company offers contract analytical services, aseptic manufacturing, and oral manufacturing solutions. It emphasizes customized solutions and timely delivery.
Pharma Tech Industries is a pharmaceutical contract manufacturer specializing in powder-based products and custom packaging services. They provide end-to-end CDMO solutions, from development to high-volume commercial production, offering various delivery systems including sachets, tablets, and capsules.
Based in Clinton, TN, Pharma Packaging Solutions is a pharmaceutical contract packaging company. They provide agile, compliant, and innovative packaging solutions designed for every stage of the pharmaceutical lifecycle. The company offers essential services to the pharmaceutical industry.
Based in Solana Beach, CA, PiSA USA offers comprehensive pharmaceutical and medical device contract manufacturing. Services include integrated product development, design for manufacturing, and production. Capabilities cover aseptic blow-fill-sealing, injectables, oral solutions, oral solids, lyophilized powders, and packaging. They also provide in-house ETO sterilization.
Pyramid Pharma Services, Inc. provides aseptic manufacturing, development, and analytical services for parenteral drugs. It offers CDMO services from pre-clinical development through commercial supply and regulatory support for biologics, peptide, and small molecule drugs. The company operates a 90,000-square-foot, GMP-compliant facility.
RC Outsourcing is an FDA-registered 503B outsourcing facility in the United States, specializing in sterile and non-sterile pharmaceutical compounding. The company offers repackaging services, with a primary focus on Avastin®, and develops proprietary topical anesthetics like LTP Ointment, adhering to rigorous quality and safety standards.
Based in Wayne, NJ, Reed-Lane provides contract packaging for pharmaceutical companies. The company specializes in services such as blister packaging, bottling, pouching, and convenience vial filling. They also offer cold chain storage, serialization, and kitting for RX, OTC, and generic pharmaceuticals.
Based in San Francisco, CA, National Resilience, LLC. operates as a biomanufacturing Contract Development and Manufacturing Organization (CDMO). The company specializes in improving access to complex medicines, offering end-to-end solutions for safe and scalable manufacturing. They focus on revolutionizing the development and scaling of novel therapeutics.
Safecor Health provides comprehensive pharmaceutical contract packaging services, specializing in compliance, unit-dose, and late-stage customization. Operating FDA-registered and DEA-licensed facilities, they offer solutions like blister packaging, bottle filling, pouching, kitting, and serialization. Safecor Health serves pharmaceutical manufacturers, wholesalers, and GPOs.
Based in Santee, CA, Scantibodies Laboratory, Inc. provides pharmaceutical contract manufacturing and lyophilization services. With over 45 years of experience, they specialize in producing monoclonal/polyclonal antibodies, blocking reagents, controls, plasma, and serum for biotech and medical device applications. Services also include labeling, packaging, and warehousing.
Based in Little Rock, AR, SCA Pharma is an FDA 503B outsourcing facility, providing sterile admixtures and pre-filled syringes. They partner with hospitals and healthcare facilities, delivering pharmaceutical products to improve operational efficiency. The company operates state-of-the-art facilities with a robust Pharmaceutical Quality System.
Based in Macungie, PA, Sharp Services, LLC specializes in pharmaceutical contract manufacturing and packaging. They provide sterile manufacturing for clinical and small-scale commercial drug products, alongside comprehensive clinical supply chain services. The company delivers innovative primary and secondary packaging solutions from its GMP facilities.
Based in San Diego, CA, SK pharmteco Inc. is a Contract Development and Manufacturing Organization (CDMO). The company provides comprehensive drug development and manufacturing services for small molecule, biologic, and cell and gene therapies. They handle manufacturing and testing from early development to commercial scale.
Based in Fort Worth, TX, Sovereign Pharmaceuticals provides CDMO services for pharmaceutical companies. They offer formulation development, clinical trials, QA, regulatory support, and manufacturing. Capabilities include solid dose products (tablets, capsules) and various liquid solutions (oral, topical, otic), plus fill/finish and packaging.
STAQ Pharma is an FDA-registered 503B outsourcing partner providing critical medications for pediatric and adult patients. Backed by hospitals, the company combats drug shortages, ensuring reliable supply to healthcare providers nationwide. They uphold rigorous quality control in their 503B manufacturing operations, prioritizing safety and compliance.
Based in Newton, MA, STC Biologics is a CDMO company specializing in advancing biologic products from discovery to commercialization. They integrate biology into CMC development, offering services to overcome drug development hurdles. The company provides comprehensive analytical packages to achieve desired product profiles.
Based in Carrollton, TX, Swiss American CDMO is a full-service Contract Development & Manufacturing Organization. They specialize in developing and manufacturing topical skin and wound care products for global brands. Their comprehensive solutions cover discovery, innovation, development, and commercialization, leveraging over 35 years of experience.
Based in Arcadia, CA, Theragent is a full-service, cGMP compliant CDMO specializing in cell and gene therapy. They provide contract research, process development, analytical development, clinical manufacturing, and regulatory support services for cell and gene therapy sponsors.
Based in Allentown, PA, USSF specializes in complex pharmaceutical contract manufacturing. They guide healthcare and new drug inventors from method analysis to cGMP commercial formulation and product development. Leveraging expertise in research, analytics, and advanced manufacturing, they deliver regulatory-conforming clinical materials.
Based in Conroe, TX, VGXI is a Contract Development and Manufacturing Organization (CDMO). The company specializes in nucleic acid-based products, manufacturing plasmid DNA for pre-clinical, highly documented, and cGMP applications. Services support human clinical trials, diagnostic reagents, and cell and gene therapy production.
Based in Elkridge, MD, VICI Health Sciences is a full-service CDMO partner for emerging pharma. The company provides drug development, contract manufacturing, and testing services, including formulation, cGMP clinical supplies, and analytical support. They specialize in oral and topical dosage forms, offering solutions for NCE, NDA 505(b)(2), and ANDA programs.
Based in Houston, TX, Wilcrest Pharma is a 503B outsourcing facility that provides CGMP manufacturing services for challenging medications. They offer formulation expertise and focus on supply chain resilience, delivering quality solutions to healthcare organizations while prioritizing patient care.
Based in Houston, TX, Willowbend Pharma Select is an FDA-registered 503B sterile compounding facility. It focuses on supply chain resiliency and patient safety by providing compounded sterile preparations during shortages. The company specializes in wellness, weight loss, and hormone replacement therapy, adhering to cGMP guidelines.
Woodstock Sterile Solutions specializes in sterile development and manufacturing for complex liquid pharmaceutical projects. The company employs advanced aseptic blow-fill-seal (BFS) technology to form, fill, and seal product containers. They offer BFS filling services for ophthalmic and respiratory applications, supporting projects from clinical development to large-scale commercial production.
Ardena is an integrated specialist Contract Development and Manufacturing Organization (CDMO) providing pharmaceutical contract manufacturing services. They operate state-of-the-art GMP facilities in the US for clinical and commercial production. The company specializes in precision medicine development of new, innovative, and complex molecules.
Based in San Diego, CA, Excellos operates as a cell therapy CDMO, providing cGMP manufacturing for advanced therapeutic programs. The company specializes in adoptive cell therapies, including TIL, Autologous and Allogeneic CAR-T/NK, and TCR Therapies. Services encompass donor sourcing, deep cell characterization, and large-scale cell expansion in ISO 7 cleanrooms.
Based in Boston, MA, Flamma Group operates as a CDMO, manufacturing small molecule APIs for the pharmaceutical industry. The company leverages its global facilities, including locations in Italy, the USA, and China, to provide a secure supply chain for clients.
Hikma Pharmaceuticals PLC provides high-quality manufacturing capabilities for injectable, oral, and respiratory pharmaceutical products. The company combines reliability and flexibility in its state-of-the-art facilities, serving a range of pharmaceutical needs.
Based in Fort Worth, TX, QCDMO specializes in contract development and manufacturing (CDMO) services. They produce OTC and prescription drug products, dietary supplements, and professional skincare. Capabilities include product development, formulation, manufacturing (suppositories, liquids, semi-solids), packaging, and laboratory testing.
Quotient Sciences offers integrated drug development and manufacturing services, spanning candidate selection to commercial supply. The company specializes in formulation development, clinical manufacturing, and sustained commercial production. It provides CRDMO services with US- and UK-based GMP-compliant facilities for pharmaceutical programs.
Based in Spokane, WA, Selkirk Pharma provides sterile fill/finish contract manufacturing for injectable drug products. The company focuses on on-time delivery for pharmaceutical clients, offering rapid manufacturing of clinical trial materials through its exclusive ClinFAST™ program. It supports efficient drug development and production needs.
Based in Clinton, TN, Tjoapack provides comprehensive pharmaceutical contract packaging services. They specialize in primary and secondary packaging for oral solids, unit dose products, bottles, injectables, pre-filled syringes, and pharmaceutical vials. Their offerings include kitting, clinical trials packaging, and logistics management for a dependable and safe supply chain.
Based in Philadelphia, PA, Adare Pharma Solutions is a specialized CDMO focused on oral dosage forms for the pharmaceutical industry. They offer comprehensive product development through commercial manufacturing, addressing challenges such as taste-masking, customized release, and solubility enhancement. Services also include analytical testing, packaging, serialization, and global logistics support.
Based in Carlsbad, CA, Argonaut Manufacturing Services is a contract manufacturing organization (CMO) specializing in pharmaceutical, diagnostic, and life science products. Their services include aseptic and non-aseptic drug fill finish, lyophilization, drug-device combination product manufacturing, and comprehensive analytical and quality control support.
Based in Brunswick, NJ, Ascendia CDMO offers comprehensive pharmaceutical solutions, spanning pre-formulation through commercialization. The company partners with pharmaceutical and biological companies, leveraging nanotechnologies and sophisticated processes to overcome complex drug development and manufacturing challenges.
August Bioservices, based in Nashville, TN, provides fully integrated drug development, testing, and manufacturing services. Specializing in high-quality, scalable sterile injectable manufacturing, the company supports pharmaceutical projects from early-phase through commercial production, leveraging advanced technology and end-to-end solutions.
Avid Bioservices, Inc. is a Contract Development and Manufacturing Organization (CDMO) specializing in biologics. With over 30 years of experience, the company provides mammalian protein development, manufacturing, and viral vector resources, guiding molecules from concept to market.
Catalent is a global contract development and manufacturing organization (CDMO) for pharma, biotech, and self-care companies. They offer end-to-end solutions for drug development, manufacturing, and product delivery. Their services include oral dose, biologics, clinical supply, OTC, and dietary supplements, utilizing advanced technologies and a worldwide network.
Based in The Woodlands, TX, Cellipont Bioservices provides contract development and manufacturing services for advanced cell therapies. The company offers process and analytical development, clinical manufacturing, and cGMP production for CAR-T, allogeneic cell therapy, iPSC services, and exosome manufacturing within its purpose-built facility.
Based in San Antonio, TX, DPT Laboratories, LTD. is a cGMP pharmaceutical contract manufacturer and CDMO partner. They offer comprehensive services from drug pre-formulation and analytical development to clinical trial supplies and commercial scale manufacturing. Capabilities include semi-solid manufacturing and fill-finish services for various pharmaceutical products.
Empower Pharmacy operates FDA-registered, cGMP-compliant 503A and 503B outsourcing facilities, providing sterile compounding services. They produce high-quality, custom medications at scale, adhering to stringent regulatory standards from ingredient sourcing to fulfillment, with nationwide shipping for various patient needs.
Based in Wichita, KS, Fagron Compounding Services is a DEA and FDA-registered 503B pharmaceutical outsourcing company. It manufactures and repackages high-quality sterile medications. With three facilities totaling over 268K sq ft, the company conducts 100% batch testing for sterility and potency, ensuring patient safety and supply chain resiliency.
Fortis Life Sciences provides Contract Development and Manufacturing Organization (CDMO) services for life science and diagnostics companies. They specialize in lyophilization applications, offering integrated solutions including reagents, components, and contract R&D. The company operates manufacturing sites in both the U.S. and Canada.
Grace is a global leader in specialty chemicals, offering API development and manufacturing services. With facilities located in South Haven, Michigan, and Tyrone, Pennsylvania, the company performs all API production domestically in the U.S. for pharmaceutical clients.
Based in Grand Rapids, MI, Grand River Aseptic Manufacturing is a contract development and manufacturing organization (CDMO). It specializes in sterile injectable fill-and-finish services for liquid and lyophilized vials, syringes, and cartridges. GRAM partners with pharmaceutical and biotechnology clients, supporting clinical trials and commercialization.
Based in Spokane, WA, Jubilant HollisterStier provides pharmaceutical contract manufacturing services. The company specializes in sterile fill-finish, lyophilization, inspection, and packaging support. They also offer regulatory support, analytical services, and clinical trial manufacturing, supporting various pharmaceutical project needs.
Based in Chaska, MN, Lifecore Biomedical, Inc. is a CDMO specializing in the development and manufacturing of sterile injectable drug products. They offer expertise in specialty formulation, aseptic filling, and final packaging for complex pharmaceutical and medical device products.
Based in Ivyland, PA, Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) specializing in lyophilization (freeze-drying). LTI provides aseptic filling and manufacturing of high-quality clinical trial materials for health care products, including therapeutic injections and vaccines. Their services span product and cycle design to comprehensive process development.
Based in San Antonio, Texas, Mission Pharmacal is a pharmaceutical company providing contract development and manufacturing services. They offer a full range of customizable contract services to meet individual needs, alongside developing and commercializing their own branded, over-the-counter, and generic pharmaceutical products.
Praxis Packaging offers primary and secondary contract packaging for Rx and OTC pharmaceutical products. They operate FDA, DEA (III-V), and cGMP-compliant facilities in Michigan, New Jersey, and Florida, specializing in solid dose bottling, blister packaging, liquid filling, and comprehensive DSCSA serialization management. They provide complete turnkey solutions.
Based in Westwood, NJ, Sonic Packaging provides comprehensive contract packaging and filling services for the pharmaceutical industry. The company is FDA-registered, DEA compliant for controlled substances, and ISO certified, delivering innovative and tailored packaging solutions from concept to market.
Based in San Diego, CA, VeV Scientific, Inc. is a small-sized contract Prescription and OTC pharmaceutical manufacturer. They provide cGMP small vial lyophilization services, sterile injectables, and tablet and capsule manufacturing. The company is FDA-registered and inspected by the DEA and California Department of Public Health.
Based in Carlsbad, CA, Vista Biologicals is a Contract Development and Manufacturing Organization (CDMO) specializing in cGMP bio-manufacturing for the biotechnology and biopharmaceutical industries. They provide advanced cell culture techniques, process development, and cGMP manufacturing services, supporting pre-clinical, Phase I, and Phase II production, along with protein purification and cell banking.
Based in Durham, NC, Alcami Corporation is a US-based contract development and manufacturing organization. They specialize in advancing pharmaceuticals and biologics, offering fully integrated lab services, drug product manufacturing, and cGMP pharma storage and support services from development to delivery.
Boehringer Ingelheim provides comprehensive contract manufacturing services for mammalian and microbial biologics. With a dedicated site in Fremont, CA, they partner with clients to bring their biologics to life, offering expertise in developing and producing advanced pharmaceutical products for the healthcare industry.
Charles River Laboratories offers cGMP compliant biologics contract manufacturing services. The company specializes in accelerating the development of biopharmaceuticals, supporting clients from the initial concept phase through to final treatment.
Forge Biologics provides high-yield AAV manufacturing and viral vector services for gene therapy. Operating a world-class cGMP facility, the company offers comprehensive support from concept to commercialization. They serve researchers, foundations, biotechs, and pharmaceutical companies with specialized production capabilities.
LOTTE BIOLOGICS is a global Contract Development and Manufacturing Organization (CDMO) providing end-to-end services from development to commercial production. The company operates a manufacturing facility in Syracuse, New York, with 40,000 liters of drug substance capacity, serving patients worldwide.
NorthX Biologics operates as a Contract Development and Manufacturing Organization (CDMO) dedicated to complex biologics. Their services encompass process development, analytics, recombinant proteins, virus & vectors, plasmid DNA, cell therapy, and extracellular vesicles. They also provide aseptic fill and finish to advance product development.
Patheon provides comprehensive sterile fill-finish services for pharmaceutical companies. Utilizing global facilities, they accommodate a variety of molecules and diverse parenteral dosage formats. The company specializes in aseptic processing and packaging solutions, supporting drug product development and manufacturing needs for a broad clientele.
Pfizer CentreOne provides comprehensive pharmaceutical contract manufacturing services, leveraging Pfizer's global expertise. They specialize in oral solid dose production, sterile injectables, and antibody-drug conjugates, including potent and cytotoxic compounds. The company also offers regulatory support, IP protection, and tech transfer services for therapies.
Based in San Antonio, TX, Scorpius Biologics provides pre-clinical and clinical scale biologics contract manufacturing services. The company offers essential support for the development and production of biologic drugs, serving pharmaceutical and biotechnology clients with their manufacturing needs.
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How to Choose a Company
- Evaluate their Quality Management System (QMS) depth, ensuring it extends beyond basic cGMP compliance to cover robust deviation management, CAPA (Corrective and Preventive Actions) processes, and stringent change control relevant to your specific drug product and its lifecycle.
- For sterile injectables, confirm their expertise in aseptic fill-finish operations, including recent media fills data, HEPA filtration integrity, and robust environmental monitoring programs, not just facility photos or general statements.
- Scrutinize their technology transfer protocol and success rate, especially for complex formulations or novel Active Pharmaceutical Ingredients (APIs), demanding clear timelines, dedicated cross-functional teams, and a proven methodology for transferring analytical methods and manufacturing processes.
- Verify current DEA registration and specific scheduling experience if your project involves controlled substances (Schedules I-V), as this adds significant regulatory complexity, security requirements, and audit scrutiny.
- Red Flag/Gotcha: Beware of a contract manufacturer that downplays the need for a comprehensive Quality Agreement or rushes through its negotiation; this legally binding document forms the bedrock of clear responsibilities, cGMP compliance, and intellectual property protection.
- Assess their capabilities for analytical method development and validation, particularly for critical in-process controls and release testing, to ensure data integrity and consistent product quality throughout the manufacturing lifecycle.
- Investigate their track record with recent regulatory inspections (e.g., FDA Form 483s, Warning Letters) and their responsiveness in addressing observations, looking for a culture of continuous improvement and proactive compliance rather than merely reactive fixes.
Frequently Asked Questions
What's the difference between a CDMO and a pure CMO in pharmaceuticals?
A CDMO (Contract Development and Manufacturing Organization) offers integrated services spanning preclinical development, formulation, analytical method development, clinical trial material production, and commercial manufacturing. A pure CMO (Contract Manufacturing Organization) typically focuses solely on executing established manufacturing processes, with less emphasis on upfront R&D or extensive development support, often taking on projects with pre-defined processes.
How critical is cGMP compliance, and how can I verify it beyond audit reports?
cGMP (Current Good Manufacturing Practices) is the absolute foundation for pharmaceutical manufacturing. Beyond audit reports and certifications like PIC/S, verify a deep understanding of regulations such as 21 CFR Part 210 and 211. Look for evidence of robust batch record review, a well-defined deviation management system, and a strong, independent Quality Unit with clear oversight. During site visits, observe operational discipline, data integrity practices, and the general state of facility maintenance and personnel training.
What should I expect during a technology transfer for a drug product?
A successful technology transfer involves meticulous documentation (e.g., master batch records, analytical method transfer protocols), shared risk assessments, and dedicated cross-functional teams from both your company and the CMO. Expect a structured approach with clear milestones, often involving trial or engineering batches, and rigorous communication protocols. The goal is to reliably reproduce your process at the CMO's facility while maintaining critical quality attributes.
When does a pharmaceutical project require a DEA-registered contract manufacturer?
A DEA-registered manufacturer is mandatory if your drug product or its Active Pharmaceutical Ingredient (API) is classified as a controlled substance by the US Drug Enforcement Administration (DEA), typically falling into Schedules I-V. This classification necessitates additional security measures, highly meticulous record-keeping, and specific reporting requirements to the DEA for all aspects, from material receipt and storage to manufacturing and final product shipment.
How important are a CMO's stability studies capabilities?
Critically important. Stability studies determine the shelf-life and appropriate storage conditions for your drug product under various environmental stressors (temperature, humidity, light). A robust stability program, compliant with ICH (International Council for Harmonisation) guidelines, is essential for demonstrating that your product remains safe, pure, and effective throughout its intended shelf-life, directly informing labeling and regulatory submissions.
What regulatory filing support can I expect from a pharmaceutical CDMO?
A strong CDMO should offer comprehensive regulatory support, including compiling and reviewing CMC (Chemistry, Manufacturing, and Controls) sections for your Investigational New Drug (IND), New Drug Application (NDA), or Abbreviated New Drug Application (ANDA) submissions. This often involves drafting documentation, managing data, responding to agency questions during review periods, and ensuring all manufacturing processes and quality data align with global regulatory expectations.