Prefilled Syringe CDMOs

Delpharm

Canada

Delpharm is one of the world's top five CDMOs, specializing in the development and manufacture of medicines across solid, sterile, semi-solid, and liquid dosage forms with particular expertise in nasal sprays and injectables. The company operates 18 manufacturing sites and 3 development centers across Europe and North America, with 6,500 employees and over 1.1 billion EUR in turnover. Delpharm produces over 650 million units annually and recently received a $60 million Canadian government investment to modernize its Boucherville injectable facility.

INCOG Biopharma Services

United States

INCOG BioPharma Services is a US-based CDMO headquartered in Fishers, Indiana, providing end-to-end solutions for sterile injectable drug products from clinical through commercial phase. The company operates a purpose-built, FDA-approved and Annex 1-compliant facility with state-of-the-art fill/finish capabilities and is undergoing a $200 million expansion to boost production capacity.

Lifecore Biomedical

United States

Lifecore Biomedical (Nasdaq: LFCR) is a fully integrated CDMO headquartered in Chaska, Minnesota, specializing in sterile injectable drug product development and manufacturing. The company has over 40 years of experience in aseptic fill/finish, with particular expertise in highly viscous formulations. Lifecore is also a premium producer of non-animal-sourced sodium hyaluronate.

Northway Biotech

Lithuania

Northway Biotech is a global end-to-end biologics CDMO specializing in protein-based biologics and gene therapies. The company operates state-of-the-art facilities in Vilnius, Lithuania (EU) and Waltham, Massachusetts (US), with 20+ years of technical expertise. Northway offers cell line development, process development, analytical development, and cGMP manufacturing of drug substances and drug products using both mammalian cell culture and microbial fermentation technologies.

OneSource Specialty Pharma Limited

India

OneSource Specialty Pharma Limited (formerly Stelis Biopharma Limited) is India's first specialty pharma pure-play CDMO, offering multimodal end-to-end capabilities across drug-device combinations, complex sterile injectables, biologics, and soft gelatin capsules. The company operates five state-of-the-art facilities in Bengaluru with 35 approved ANDAs and 19 commercialized drug products in the US market.

Sharp Sterile Manufacturing

United States

Berkshire Sterile Manufacturing (now Sharp Sterile Manufacturing, acquired by Sharp in 2023) is a specialist CDMO providing sterile injectable development and manufacturing services from its isolator-based facility in Lee, Massachusetts. All fills are 100% isolator-based using Colanar fillers, supporting clinical through small-to-mid-scale commercial production of vials, syringes, and cartridges. FDA-inspected with 8 inspections (7 NAI, 1 VAI), demonstrating strong regulatory compliance.

Singota Solutions

United States

Singota Solutions is a CDMO based in Bloomington, Indiana, focused on aseptic injectable drug development and manufacturing for pharmaceutical, animal health, and biotechnology clients. They specialize in small-batch aseptic filling using the gloveless robotic SA25 Aseptic Filling system (first commercial site in North America). Services include aseptic manufacturing of small volume parenterals (vials, syringes, cartridges), QC testing, formulation and method development, labeling and kitting, and supply chain management including GMP-compliant warehousing and cold chain storage. They recently expanded into Europe with a GDP-certified facility in Balerna, Switzerland.

SMC Ltd.

Costa Rica

SMC Ltd. is a global contract manufacturer headquartered in Costa Rica with over 35 years of experience in medical device contract manufacturing and pharma services. The company offers end-to-end capabilities from device design through commercialization, including sterile fill/finish, analytical services, and drug delivery platform technologies. All facilities are FDA-registered and ISO 13485-certified.

Contract Packaging Resources is a member of the Aenova Group, a worldwide leading CDMO for the pharmaceutical and healthcare industry. The Aenova Group provides comprehensive pharmaceutical manufacturing including solid dosage forms, sterile fill and finish, semi-solids, non-sterile liquids, softgels, gummies, and packaging services. The Latina site in Italy serves as the central sterile manufacturing facility with capacity for over 100 million units per year, handling biologics including monoclonal antibodies, peptides, and vaccines with isolator technology.

Bushu Pharma is Japan's premier CDMO with over 25 years of experience, specializing in contract manufacturing of solid dosage formulations, sterile injectables, lyophilized products, and prefilled syringes for both clinical trial supplies and commercial products. The company operates five factories in Japan with GMP certifications from 56 countries including FDA, EMA, and PMDA, serving over 90 pharmaceutical companies globally with nearly 50% of sales from foreign-affiliated clients.

Caplin Point Laboratories is a fully integrated Indian pharmaceutical company with a dominant presence in Latin America and Francophone Africa, and a growing presence in the US and EU. Through its subsidiary Caplin Steriles, the company manufactures sterile injectables, ophthalmic products, pre-mix bags, and pre-filled syringes, with 46 FDA-approved products.

Oncotec Pharma Produktion GmbH is a German CDMO specializing in the development and aseptic manufacturing of cytostatic (anticancer) drugs. Founded in 1997, the company provides full-service contract manufacturing from lab-scale development through commercial production, with approximately 2,300 m2 of cleanroom space and isolator-protected production lines at its Dessau-Rosslau facility.

Division of Terumo Corporation (TSE:4543), a global healthcare technology leader since 1921 with 30,000+ employees. Provides sterile injectable contract development and manufacturing (CDMO) services from combination device design and formulation development to commercial manufacturing. Offers a portfolio of injection, infusion, and primary packaging solutions including PLAJEX polymer pre-fillable syringes, Immucise intradermal injection systems, hypodermic needles, and Surflo winged infusion sets. Recently expanded CDMO services outside Japan for global market and is doubling capacity.

Lisapharma S.p.A. is an Italian pharmaceutical company specializing in the contract manufacturing of sterile injectable products, located in Erba (Como), Italy. The company provides sterile fill/finish services for vials, syringes, and cartridges, with capabilities in lyophilization. The website domain lisapharma.com is no longer active, but the company operates from lisapharma.it and is FDA-registered for manufacturing.

Pii (Pharmaceutics International, Inc.), acquired by Jabil in February 2025, is a US-based CDMO specializing in complex formulations. With over 30 years of experience and 300+ scientists and support staff, Pii handles potent compounds, complex formulations, aseptic injectables, complex oral dosage forms, and high-potency soft gels. Offers phase-appropriate support from early development through commercial manufacturing. Located in Hunt Valley, Maryland. 100% FDA licensed with 5 drug product approvals in 2023.

PSM GmbH is a German pharmaceutical CDMO specializing in aseptic fill and finish services for drugs, biologics, and biopharmaceutical products. The company offers end-to-end commercial fill and finish services with state-of-the-art flexfill filling-line technology and formulation development capabilities. Limited website data is available, but search results consistently identify PSM as a specialized aseptic fill/finish CDMO.