Cartridge Fill-Finish CDMOs

Baxter International

China

Baxter International is a global medtech and biopharma company. Through its BioPharma Solutions (BPS) division, Baxter operates as a major CDMO providing sterile fill/finish manufacturing services. BPS invested over $150M in expanding sterile fill/finish capacity at its Bloomington, Indiana facility. Note: Baxter has signed a definitive agreement to divest its BioPharma Solutions business. Baxter has 308 FDA-approved products, extensive manufacturing facilities worldwide, and 93 FDA inspections on record.

BioGeneric Pharma (BGP)

Egypt

BioGeneric Pharma S.A.E (BGP) is an Egyptian international biopharmaceutical company specializing in the development, production, analysis, and marketing of therapeutic recombinant proteins, biosimilars, and vaccines. BGP operates a state-of-the-art biomanufacturing facility in 10th of Ramadan Industrial City, Egypt. The company offers contract manufacturing (CMO) and toll manufacturing services with capabilities spanning biomanufacturing, fill/finish (vials, PFS, cartridges), quality control labs, and mRNA technology (WHO mRNA technology transfer hub partner). Has single-use technology for upstream (25L to 2,000L bioreactors) and downstream processing.

GULF BIOTECH B.S.C CLOSED

Bahrain

Gulf Biotech is a pharmaceutical company based in Bahrain that manufactures injectable formulation products and offers contract manufacturing services for sterile formulations. The company provides lyophilized vials, cartridges, ampoules, pre-filled syringes, and sterile emulsion technology from its state-of-the-art manufacturing facility.

Novartis Contract Manufacturing

Austria

Novartis Contract Manufacturing is the CDMO arm of Novartis, offering fully integrated end-to-end manufacturing solutions across biologics (mammalian up to 15,000L, microbial up to 13,000L), small molecules (API to fill & finish), cell & gene therapy (CAR-T, AAV, LV), xRNA/LNP/pDNA, and comprehensive fill & finish services. The operation spans multiple state-of-the-art facilities across Austria, Switzerland, Slovenia, Belgium, France, Singapore, and the United States, with 107 FDA inspections and 27 FEI registrations.

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.

Pfizer CentreOne

Belgium

Pfizer CentreOne is a global CDMO embedded within Pfizer, specializing in commercial manufacturing of oral solid doses, sterile injectables, biologics including monoclonal antibodies, and antibody-drug conjugates. It leverages Pfizer's global manufacturing network across six continents with cGMP-compliant sites and over 170 years of pharmaceutical manufacturing expertise, backed by $1B+ annual manufacturing investments.

Pharmaniaga Manufacturing Berhad

Malaysia

Pharmaniaga Manufacturing Berhad is a Malaysian pharmaceutical manufacturer and CDMO offering contract manufacturing services. The company produces oral solid dosages (7 billion tablets/capsules capacity), liquids (2.9 million bottles), creams (5 million tubes), small volume injectables including ampoules/vials (43 million units), pre-filled syringes and insulin cartridges (25 million units each), and dry syrups. Products include general pharmaceuticals, penicillin, cephalosporin, and OTC products. Facilities are designed to international pharmaceutical engineering guidelines.

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.

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.

ten23 health

Switzerland

Swiss CDMO specializing in formulation, analytical and process development, sterile manufacturing (fill and finish), and testing of injectable medicines. First CDMO in the pharmaceutical industry for injectables to be B Corp certified. Operates from Basel and Visp, Switzerland. Opened new VIVA2 facility with expanded sterile manufacturing lines. QC laboratories approved by both Swissmedic/RHI and FDA. Partners with BD on Libertas wearable injector commercialization. Supports biologics, small molecules, and RNA therapeutics.

Enzene Biosciences Limited

India

Enzene Biosciences is an Indian CDMO and subsidiary of Alkem Laboratories, specializing in biologics and biosimilar development and manufacturing. The company's patented EnzeneX continuous bioprocess manufacturing platform significantly reduces the cost of producing complex biologics and monoclonal antibodies, with facilities in Pune, India and an expanding site in Hopewell, New Jersey, USA.

EVER Pharma

Austria

EVER Pharma is an Austrian fully integrated specialty pharmaceutical company and CDMO with over 60 years of sterile production experience, specializing in complex injectables. The company operates a state-of-the-art GMP facility in Jena, Germany producing 400+ pharmaceutical products, with particular expertise in highly active substances (narcotics, hormones, cytotoxics), crystal suspensions, and oily solutions in vials, pre-filled syringes, cartridges, implants, and ampoules.

Grand River Aseptic Manufacturing (GRAM)

United States

Grand River Aseptic Manufacturing (GRAM) is a premier US-based CDMO specializing exclusively in sterile injectable fill-and-finish services for liquid and lyophilized vials, pre-filled syringes, and cartridges. The company serves pharmaceutical and biotech clients with capabilities spanning clinical through commercial-scale production for biologics, small molecules, and vaccines. GRAM also partners with drug delivery device innovators to offer solutions for autoinjectors and on-body delivery systems.

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.

Kindeva Drug Delivery

United Kingdom

Kindeva Drug Delivery is a leading global drug-device combination CDMO specializing in sterile injectables, pulmonary and nasal inhalation, and dermal/transdermal drug delivery platforms. The company has a history spanning back to 1956 when it invented the pressurized metered-dose inhaler (pMDI). Kindeva operates a global network of 10 manufacturing and R&D sites including a 155,000+ sq ft dedicated aseptic operations facility in Bridgeton. They hold 12 FDA-approved products across aerosol, metered-dose, film, and extended release dosage forms. Their FDA record shows 38 inspections (9 NAI, 22 VAI, 7 OAI) and 6 FEI-registered facilities covering analysis, manufacture, and sterilization.

medac GmbH (medac CDMO)

Germany

medac GmbH operates a dedicated CDMO division (medac CDMO) offering end-to-end sterile injectable manufacturing services from clinical supply through large-scale commercial production. Based in Germany with facilities in Wedel and Dessau (Germany) and Brno (Czech Republic), medac specializes in small molecules, biologics (mAbs, proteins, peptides, oligonucleotides), and ADCs. They handle aseptic filling, terminal sterilization, lyophilization, and high-potent API processing down to OEL = 10 ng/m3. Manufacturing scales range from 1-50 L (small) to 50-1,500 L (large) with campaigns up to 11,000 L. They partner with Cerbios under the PROVEO brand for integrated ADC services. Over 40 years of regulatory expertise with approvals from multiple international health authorities.

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.

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.

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.

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.

Laboratorios Farmaceuticos ROVI S.A. is a major Spanish CDMO and pharmaceutical company, one of the leading European contract manufacturers for high-value-added injectable products. Their CDMO division (ROIS) operates three industrial complexes: two for injectables (Madrid and San Sebastian de los Reyes) and one for oral solid forms and packaging (Alcala de Henares). They also have two facilities in Granada for their own products (bemiparin and enoxaparin). ROVI's Madrid injectables plant is approved by EMA, FDA, and regulators in Korea, Brazil, and Gulf States, with ISO 9001, ISO 14001, and OSHAS certifications. They recently acquired a Bristol-Myers Squibb injectable drug product manufacturing site in Phoenix, Arizona for $250 million, expanding their capacity. ROVI provides end-to-end services from development to final product release, including clinical trials, stability studies, and analytical services. They have collaborated with Roche for manufacturing new medicines in development.

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.

Stelis Biopharma is a leading, fully integrated biopharmaceutical CDMO based in India (Bangalore) with over 30 years of operational excellence. They brand themselves as 'OneSource' -- a multimodal specialty pharma CDMO with end-to-end capabilities across multiple tech platforms and therapeutic modalities. Their capabilities span biologics (microbial and mammalian cell culture, drug substance and drug product), complex sterile injectables (35 approved ANDAs and 19 commercialized drug products in the US), drug-device combinations (20+ automatic/semi-automatic assembly stations for prefilled syringes, pen injectors, autoinjectors), and soft gelatin capsules (2.4 billion per year capacity). They operate 5 state-of-the-art facilities approved by various regulatory bodies. Syngene acquired Stelis Biopharma's Unit 3 plant in Bangalore for biologics manufacturing.

LubecaFill

Germany

LubecaFill is a German contract filling company offering sterile filling services for liquid dosage forms using Ready-to-Fill (RTF) technology. They provide filling into pre-sterilized vials, syringes, and cartridges, as well as contract filling of ampoules, oral and topical liquid dosage forms, and diagnostics/laboratory consumables. GMP certification is in preparation.

Lyophilization Technology, Inc. (LTI)

United States

Lyophilization Technology, Inc. (LTI) is a US-based CDMO focused on lyophilization (freeze-drying) development and sterile clinical supply manufacturing. They offer development sciences (formulation development, thermal analysis, cycle design, product characterization, pilot plant scale-up), clinical manufacturing (Phase I, II, and toxicology), and technical services. They have specialized capabilities in dual chamber cartridges and syringes, and isolation/containment for potent compounds.