Manufacturing pharmaceutical products for human use requires a high level of precision, safety, and regulatory compliance. A human drugs CDMO provides specialized support for the development, manufacturing, and quality control of human medicinal products, from early-phase trials to commercial distribution.
Whether you’re a biotech startup or a global pharma company, partnering with a provider of human medicinal products contract manufacturing ensures that your drug development process is backed by experience, scalability, and GMP-compliant execution.
How to Choose a Human Medicinal Products Contract Manufacturing Partner
When selecting a manufacturing partner for human drugs, it’s critical to assess not only capabilities but also experience with global health authorities and therapeutic categories. Key factors include:
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Compliance with EMA, FDA, and WHO standards
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Experience with your dosage form or therapeutic class
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Full GMP certification for clinical and commercial manufacturing
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Robust quality systems and data integrity policies
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Scalable infrastructure to support product lifecycle growth
Trust, communication, and long-term alignment are essential when selecting a CDMO for human health products.
Key Services Offered by Human Drugs CDMOs
Formulation & Process Development: Support for a variety of dosage forms including oral solids, liquids, injectables, and sterile products.
Clinical & Commercial Manufacturing: GMP-compliant production from Phase I to market supply, including small and large-scale batches.
Analytical Services: In-house QC/QA testing, method validation, and ICH stability studies.
Regulatory Support: Assistance with CMC documentation and submission strategies tailored to global health authorities.
Packaging & Serialization: Patient-ready presentation with tamper-evident packaging, labeling, and track-and-trace capabilities.
Advantages of Partnering with Human Drugs CDMOs
Specialization in Human Use Products: CDMOs focused on human health ensure full compliance with regulatory and pharmacovigilance requirements.
Global Market Access: Capabilities aligned with EU, US, and international regulatory frameworks streamline product registration.
Integrated Services: End-to-end offerings minimize risks and reduce time-to-market across all stages.
Therapeutic Versatility: Experience across a broad range of therapeutic areas, from oncology to infectious diseases and beyond.
Focus on Patient Safety: Stringent quality control and traceability from raw materials to final product release.
Human drugs CDMO Companies
Some of the top human medicinal products CDMO companies:
- Lannett CDMO: Lannetts main manufacturing site sits in Seymour, Indiana, and includes capabilities for Oral Solid Dose (OSD) and Liquids. [See CDMO profile]
- CDM Lavoisier: Human drugs CDMO specialized in the manufacturing of glass ampoules, glass vials and plastic (BFS) ampoules. [See CDMO profile]
- Cenexi: CDMO that specializes in the production of sterile highly potent injectables, mainly against cancer. [See CDMO profile]
- FAES FARMA: Developer and manufacturer of human medicinal products. [See CDMO profile]
- ASCIL Biopharm: GMP facility fully equipped for R&D and pharmaceutical development. [See CDMO profile]
- Grifols: Sterile manufacturing solutions (small molecules) in flexible bags and vials. [See CDMO profile]
- VIVUNT PHARMA: CDMO for sterile oncology drugs. [See CDMO profile]
- Liof Pharma: Reliable CDMO partner for aseptic manufacturing and lyophilization of biologics and injectable drugs. [See CDMO profile]
- Reig Jofre: Injectable (lyo and liquid) and liquid manufacturing facilities. [See CDMO]
- Pharmaloop: Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets. [See CDMO profile]
- HIPRA BIOTECH SERVICES: End-to-end internal capabilities from cell line development to commercial manufacturing. [See CDMO profile]
- Skyepharma: Development and delivery of oral technologies serving the global pharmaceutical, biotech and consumer health industries. [See CDMO profile]
- Ophtapharm, a Sentiss Company: Ophthalmic and Otic - Solutions, suspensions, emulsions, ointments and gels - FDA Approved facility. [See CDMO profile]
- CARBOGEN AMCIS: Highly Potent APIs development and small-scale cGMP production including chromatography and lyophilization. [See CDMO profile]
- Sichuan Huiyu Pharmaceuticals Co., Ltd: Manufacturing Site and Formulation Manufacturing Site, the R&D Center supports development of both APIs and finished dosage forms. [See CDMO profile]
- AdhexPharma SAS: CDMO for transdermal patches and oromucosal films. [See CDMO profile]
- Apeloa Pharmaceutical Co., Ltd: Development and manufacturing services for APIs, Intermediates, and Registered Starting Materials. [See CDMO profile]
- Glatt Pharmaceutical Services GmbH Co. & KG: cGMP-compliant CDMO for end-to-end services in the complex oral solids dosage forms field. [See CDMO profile]
- Lukas Heil-Betriebsstätte: High-performance production facility complying with GMP standards for sterile and aseptic liquids, particularly glass ampoules. [See CDMO profile]
- Darnytsia Kyiv: CMO combining advanced facilities, stringent quality control, and expert staff to deliver reliable, compliant, and innovative solutions. [See CDMO profile]
- Adragos Pharma: Over 100 years of experience providing first-class service and customer-focused manufacturing. [See CDMO profile]
- Cellex Cell Professionals: CGT CDMO Cell Manufacturing Plant and Collection Center for Starting Materials. [See CDMO profile]
- BAG Health Care: Parenteral F&F provider for vials in small to mid-sized batches and investigational products. [See CDMO profile]
- Ascendia Pharmaceutical Solutions: GMP-certified CDMO for advanced sterile and non-sterile pharmaceutical manufacturing, formulation development, and analytical testing. [See CDMO profile]
- MENADIONA S.L: For APIs, Intermediates and fine chemicals specialized in transferring R&D projects into fully cGMP-compliant manufacturing processes. [See CDMO profile]
- i+Med: Developer and manufacturer of new drug products with controlled release technologies. [See CDMO profile]
- Content Group: Tubilux Pharma: registered office; manufacturing facility. [See CDMO profile]
- ChemCon GmbH: Contract development and manufacturing partner for APIs and fine chemicals specialized in transferring R&D projects into fully cGMP-compliant manufacturing processes. [See CDMO profile]
- Sidefarma: Manufacture of small and medium-size batches for pharmaceutical companies across regulated markets following European quality standards. [See CDMO profile]
- TRADICHEM INDUSTRIAL SERVICES: HIPERING® TECHNOLOGY - The gateway for lean manufacturing. [See CDMO profile]
- 53Biologics Production Plant: Specialized in decoding biologics production, from DNA to proteins, providing preclinical to cGMP manufacturing. [See CDMO profile]
- HISTOCELL S.L: Develops and manufactures cell therapies from iPSCs, MSCs, secretomes, exosomes and other cell types, as well as medical devices and dermocosmetics. [See CDMO profile]
- Mabion cGMP Facility: Development and GMP manufacturing of biotherapeutics, including monoclonal antibodies and recombinant protein-based products. [See CDMO profile]
- Shilpa Biologicals Private Limited: Supports process development, gene to cell line development to GMP, formulation development, analytical development, drug substance, drug product, fill-finish and packaging. [See CDMO profile]
- Pharmaron API Commercial Synthesis: Commercial API small molecules/peptides synthesis. [See CDMO profile]
- Viswa Laboratories: CRAMS/CDMO, APIs, Intermediates and specialty chemicals. [See CDMO profile]
- Rioja Nature Pharma: CDMO nutraceuticals/food supplements. [See CDMO profile]
- Cambrex: CDMO that develops and manufactures proprietary products (generic APIs) and provides contract manufacturing services for intermediates and custom APIs at commercial scale. [See CDMO profile]
- Aenova Group: Competence center for conventional solids and clinical services. [See CDMO profile]
- Sylentis: Oligonucleotide manufacturer. [See CDMO profile]
- Basic Pharma Manufacturing: Can bring your pharmaceuticals from lab scale to early clinical phase and beyond, implementing relevant quality guidelines at every step. [See CDMO profile]
- White Raven: Fill and finish site dedicated to GMP formulation and aseptic filling of sterile liquid injectables. [See CDMO profile]
- VIVEbiotech: GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors. [See CDMO profile]
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Let MAI CDMO Help You Find the Right Human Drugs CDMO Partner
Finding the right partner for your human drug product is essential to ensuring patient safety, product efficacy, and regulatory success. At MAI CDMO, we connect you with top-tier CDMOs specializing in human medicinal products contract manufacturing.
Our team of industry experts helps you define your technical and compliance needs, and matches you with qualified partners for every phase of your drug’s lifecycle.
Get in touch with MAI CDMO to discover trusted human drugs CDMO partners that meet the highest standards in pharma manufacturing.
