Pre-Filled Syringe CDMOs

Zydus Lifesciences Ltd

India

Zydus Lifesciences Ltd. (formerly Cadila Healthcare) is a major Indian pharmaceutical company headquartered in Ahmedabad, Gujarat, ranked 4th in the Indian pharma industry with 29,000+ employees globally. In June 2025, Zydus entered the global biologics CDMO business by acquiring Agenus Inc.'s U.S. manufacturing facilities in Emeryville and Berkeley, California for $75M upfront (plus $50M milestones), now operating as independent subsidiary Zylidac Bio LLC. These facilities provide end-to-end biologics development and manufacturing from pre-clinical to commercial stages, including monoclonal antibody manufacturing for Phase-3 immuno-oncology products (Botensilimab and Balstilimab). Zydus has 15 FDA-registered facilities, 156 FDA-approved products across capsules, tablets, creams, gels, injectables (including liposomal), ointments, suppositories, and transdermal patches. They have 58 FDA inspections (25 NAI, 28 VAI, 5 OAI) and 51 recalls (2 Class I, 40 Class II, 9 Class III). Manufacturing sites span Gujarat, Maharashtra, Goa, Himachal Pradesh, Sikkim (India), plus US (Vermont, Pennsylvania, Missouri) and Brazil. Their CDMO services are specifically the biologics arm through Zylidac Bio -- the broader Zydus business is primarily own-brand generic pharmaceuticals.

Afton Scientific

United States

Afton Scientific is a pharmaceutical CDMO with over 20 years of expertise in aseptic manufacturing for biologics and small molecules. The company operates FDA-inspected facilities with a 99.9% on-time delivery rate and is investing in multi-year expansion of sterile fill-finish capabilities, including new technologies for improved efficiency and increased production capacity.

Alcami

United States

Alcami is a US-based CDMO with 45+ years of experience providing integrated drug product manufacturing, laboratory services, and cGMP pharmaceutical storage. The company specializes in sterile fill-finish manufacturing (liquid and lyophilized injectables, prefilled syringes) and oral solid dose, with DEA licensing for controlled substances and EU/Annex 1 compliance.

American Injectables

United States

American Injectables is a privately held, FDA-approved CDMO specializing in sterile injectable drug products. Based in Florida, the company provides end-to-end services from formulation development through commercial manufacturing, with capabilities in aseptic fill/finish for vials and syringes, analytical testing, packaging, and serialization.

Artesan Pharma

Germany

Artesan Pharma is a German full-service CDMO based in Luechow, specializing in pharmaceutical contract development and manufacturing with 501-1,000 employees. They provide services spanning formulation development to commercial manufacturing across multiple dosage forms including oral solid doses (tablets, capsules, pellets), sterile prefilled syringes with innovative production processes, and liquids. They also offer serialization, final packaging (blister), and terminal steam sterilization capabilities.

August Bioservices

United States

August Bioservices is a US-based CDMO headquartered in Nashville, Tennessee, specializing in sterile injectable drug product development and manufacturing. They offer end-to-end services from lab-scale process development through commercial manufacturing, including formulation, analytical method development and validation, sterile filling for vials, syringes, and IV bags using both stainless steel and single-use technology (1L to 4000L), lyophilization, automated visual inspection, assembly, labeling, packaging, and serialization. The company operates fully isolated filling lines and drug-device combination product capabilities.

BioCina

Australia

BioCina is a global end-to-end biologics CDMO and the only biologics CDMO in Australia approved by the US FDA. Following the merger with NovaCina, the company provides comprehensive biologics CDMO services spanning cell line development, process development, analytical development, GMP manufacturing of biologics drug substance and drug product, and mRNA manufacturing. Operates facilities in Adelaide, Australia with GMP manufacturing capacity up to 1,000L bioreactors.

BioConnection

Netherlands

BioConnection is a contract manufacturing organization (CMO) based in Oss, The Netherlands, specializing in aseptic fill and finish services for sterile drug products. The company offers flexible development and GMP-compliant manufacturing for both innovative and generic biopharmaceutical companies, with capabilities in vials, syringes, and lyophilized products. Partnered with AGC Biologics for drug product services. FDA-registered with 17 inspections (6 NAI, 11 VAI), demonstrating extensive regulatory history.

Cenexi

Belgium

Cenexi is a Belgian/French CDMO specializing in sterile products, biological and injectable pharmaceutical manufacturing. The company operates four manufacturing sites in Europe, including sites in Fontenay-sous-Bois and Herouville-Saint-Clair (France), Osny (France, for highly active solid pharmaceutical forms), and Belgium. Cenexi offers services from development to commercial production for pre-filled syringes, vials, lyophilized products, tablets, capsules, and syrups, with FDA-registered manufacturing operations.

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.

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.

Exela Pharma Sciences

United States

Exela Pharma Sciences is a US-based integrated specialty pharmaceutical company and CDMO founded in 2005, specializing in sterile injectable development and manufacturing. The company operates FDA-inspected cGMP facilities in Lenoir, North Carolina, with capacity to produce over 100 million sterilized units annually across liquid vials, IV bags, lyophilized vials, and pre-filled syringes.

Fisher BioServices (Thermo Fisher)

Netherlands

Fisher BioServices is part of Thermo Fisher Scientific's Patheon pharma services division, one of the world's largest CDMOs offering end-to-end 360-degree CDMO and CRO solutions. The Patheon platform covers drug substance and drug product manufacturing for small molecules, large molecules, and advanced therapies, along with clinical supply and commercialization services.

GP Pharm S.A.

Spain

GP Pharm S.A. is a Spanish CDMO specializing in sterile injectable manufacturing, with particular expertise in long-acting injectable depot formulations including microspheres and sustained-release systems. The company offers contract development and manufacturing services from formulation development through commercial production, with capabilities in aseptic processing, fill/finish for vials and pre-filled syringes, and lyophilization.

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.

Kemwell Biopharma Private Limited

India

Kemwell Biopharma is one of India's largest biologics CDMOs, providing integrated drug substance and drug product development and manufacturing services from a single site in Bangalore. Established with technological support from a leading German biopharmaceutical company, Kemwell serves global pharma and biotech organizations with capabilities spanning monoclonal antibodies, complex fusion proteins, recombinant proteins, and bispecific antibodies. The company has received U.S. FDA approval for commercial drug product manufacturing and operates hybrid biomanufacturing with both stainless steel and single-use bioreactor systems.

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.

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.

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.

MEMPHIS VISION CARE PVT. LTD.

India

Memphis Vision Care Pvt Ltd (MVCPL) is an Indian pharmaceutical company based in Chhatral, Gujarat, that manufactures, supplies, and exports parenteral formulations packed in sterile pre-filled syringes (PFS). Their product segments include ophthalmic care (HPMC ophthalmic solution, sodium hyaluronate, trypan blue), cardiac/critical care (enoxaparin sodium injection, heparin sodium injection), orthopedic (sodium hyaluronate orthopaedic injection), gynecology (iron sucrose injection), and nutritive supplements (phytomenadione injection). The company operates under a hygienic controlled environment with focus on quality commitment and diverse parenteral portfolio.

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.

Pharmapac (UK) Ltd

United Kingdom

PharmaPac UK Ltd is a Contract Manufacturing Organisation (CMO) that specialises in the manufacture and packaging of a variety of drug delivery systems. The company provides pharmaceutical manufacturing, filling, and packing services for medicinal products. With 150+ employees and led by a General Manager, the company has capabilities in injectable packaging and contract manufacturing. No website data was available for detailed capability analysis.

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.

European Medical Contract Manufacturing (EMCM)

Netherlands

European Medical Contract Manufacturing (EMCM) is a Dutch full-service contract manufacturer and centre of excellence in developing and manufacturing sterile medicinal products for the pharmaceutical and medical device markets. The company has 2000m2 of GMP-accredited facilities with cleanrooms from class D to class A, handling liquids, suspensions, gels, and powders in ampoules, vials, pre-filled syringes, and pouches.

Fareva

Brazil

Fareva is a family-owned French CDMO and the largest in France, employing 13,000 people across 41 production sites in 13 countries with EUR 2.22 billion revenue in 2025. The company provides comprehensive pharmaceutical subcontracting from API manufacturing (including HPAPIs, cytotoxics, hormones, steroids, and controlled substances) to finished drug product manufacturing and packaging across oral, sterile injectable, nasal, ophthalmic, and semi-solid dosage forms.

GC Biopharma

South Korea

GC Biopharma is a South Korean biopharmaceutical company specializing in vaccines, plasma-derived therapies, and biologics. The company provides Vial and Pre-Filled Syringe (PFS) Fill & Finish CMO services and drug product (DP) manufacturing as CDMO services. GC Biopharma has established an mRNA production facility at its Hwasun plant and operates multiple manufacturing sites including Ochang, Hwasun, and Eumseong plants.

Groupe SYNERLAB CDMO

France

Groupe SYNERLAB (now operating as Meribel Pharma Solutions) is a mid-size European CDMO with an integrated network of manufacturing sites across Europe, providing end-to-end services from API manufacturing through finished dosage forms. The company specializes in sterile multidoses, sterile and non-sterile lyophilized products, sachets, stick packs, oral solid dose, liquids, and semi-solids.

Grünenthal PRO (Grünenthal CDMO)

Chile

Duplicate entry of Grunenthal PRO (company ID 8756785b). Grunenthal PRO is the contract manufacturing arm of Grunenthal Group, operating five specialized plants with vertically integrated manufacturing from active substance to finished products. Approximately 50% of total production is for third-party clients across 100+ countries.

Jubilant HollisterStier CMO

Canada

Jubilant HollisterStier CMO (subsidiary of Jubilant Pharma) specializes in sterile fill-finish, lyophilization, injectables, ophthalmics, otics, topicals, and liquids for pharmaceutical and biopharmaceutical clients. End-to-end services from process development to inspection and packaging. Facilities in Spokane, WA and Montreal, QC. Won AWB Manufacturer of the Year 2024 and Manufacturing Excellence Award 2025. Largest manufacturer by employees in Spokane area. 92% repeat customer rate. FDA registered with 4 FEI numbers, 28 inspections (6 NAI, 18 VAI, 4 OAI -- elevated regulatory risk).

Latitude Pharmaceuticals Inc

United States

Latitude Pharmaceuticals Inc is a San Diego, CA-based CRO/CMO (CRDMO) providing innovative drug formulation development and GMP manufacturing services. Founded in 2003, the company has completed over 900 pharmaceutical formulation development projects for 250+ client companies. Specializes in solving complex drug formulation challenges, particularly for insoluble APIs using their proprietary CLEARSOL platform. Provides GLP- and GMP-compliant manufacturing and analytical testing services for IND-enabling studies and Phase 1-2 clinical trial materials, including sterile injectables, fill/finish, lyophilization, vials, pre-filled syringes, and IV bags.

Montage Laboratories Private Limited

India

Montage Laboratories Private Limited is an Indian pharmaceutical formulations manufacturer based in Himatnagar, Gujarat with 30+ years of experience. The company specializes in sex hormone formulations and injectables, with dedicated facilities for sex hormone injection manufacturing (ampoules, vials, pre-filled syringes) and both beta-lactam and general injectable production. FDA-registered with 3 FEI numbers and 14 FDA inspections (12 NAI, 2 VAI — excellent track record). ISO 9001:2015 and ISO 14001:2015 certified, D&B certified.

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.

STA Pharmaceutical Co., Ltd. (WuXi STA) is a subsidiary of WuXi AppTec and one of the world's leading CDMOs, specializing in integrated CMC services for small molecule APIs and drug products (oral and injectable/sterile) from preclinical to commercial scale. They also have capabilities in oligonucleotides, peptides, and bioconjugates. WuXi STA operates 9-14 global manufacturing sites across Asia, North America, and Europe with uniform quality/EHS standards approved by major regulators. They have supported 50+ first-time drug approvals since 2017 across 105 countries. The company has 5,100+ scientists, claims 100% PPQ success rate, and serves 1,200+ customers. Their Changzhou site has passed US FDA inspection and they have a continuous manufacturing line for oral solid dose.

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.

Macleods Pharmaceuticals Ltd

India

Macleods Pharmaceuticals Ltd is one of India's top 10 pharmaceutical companies, operating as a CDMO for developing, manufacturing, and globally distributing pharmaceutical products. They produce diverse dosage forms including solid orals, liquid orals, topical formulations, injectables, metered dose inhalers, and dry powder inhalers across therapeutic areas including anti-TB, antimalarials, antiretrovirals, antidiabetics, antihypertensives, and antiasthmatics. They have 152 FDA-approved products, WHO prequalified medicines, and manufacturing facilities compliant with UK MHRA, US FDA, TGA, and WHO guidelines. They operate in 100+ countries.

National Resilience Inc.

Canada

Major North American biomanufacturing CDMO (branded as 'Resilience') focused on complex medicines including large molecule biologics, cell therapies, and aseptic drug product manufacturing. Operates facilities across the US and Canada. Delivers 100+ million vials and pre-filled syringes annually. Secured $825 million in financing to accelerate CDMO strategy. Offers proprietary technology platforms including Sprout Solutions, Auto-T, DAR-T (next-gen CAR-T), and Idea to Clinic services. FDA registered with 7 FEI numbers, 17 inspections.

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.