Sterile Injectable CDMOs

Bruschettini S.r.l.

Italy

Bruschettini S.r.l. is an Italian pharmaceutical company based in Genoa that provides contract manufacturing services for sterile injectable and lyophilized products. The company is listed on CMO/CRO directories and appears in contract pharmaceutical dose manufacturing industry reports as a provider of sterile manufacturing capabilities.

CATUG (CATUG Biotech)

China

CATUG Biotech (also known as CATUG Biotechnology) is a Chinese CRDMO specializing in plasmid DNA, mRNA, and delivery system manufacturing for cell and gene therapy and nucleic acid therapeutics. The company operates a one-stop service platform covering plasmid CDMO, mRNA CDMO, and delivery system CDMO services, including GMP manufacturing, sterile filling, and analytical/quality study services. CATUG provides end-to-end support from research customization through CMC to technology transfer and GMP production.

CD Formulation

United States

CD Formulation provides formulation development, analytical services, drug packaging, and pharmaceutical excipient solutions for pharmaceutical and biotechnology companies. The company offers contract manufacturing and contract research services including liposome cGMP manufacturing, accelerated stability studies, and a wide range of formulation types including oral solid, injectable, and topical formulations. They also supply pharmaceutical excipients and active pharmaceutical ingredients.

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.

Cipla

China

Cipla is a major Indian multinational pharmaceutical company that manufactures and markets its own branded generic medicines globally. While Cipla has formed joint ventures with CDMOs like Kemwell Biopharma for biosimilar development, the company itself is a pharmaceutical manufacturer selling its own products, not a contract manufacturer for others.

CRAMSN Research Park

India

CRAMSN Research Park is an India-based contract research, development, and manufacturing organization offering end-to-end CRO, CDMO, and CMO solutions. The company provides drug substance (API) and drug product manufacturing with multiple facilities in India and a facility in New Jersey, USA, committed to sustainable practices including green chemistry and solar-powered operations.

Dalton Pharma Services

Canada

Dalton Pharma Services is a Canadian CDMO and subsidiary of Seikagaku Corporation Japan, providing integrated drug discovery, development, and manufacturing services. The company is FDA-inspected and Health Canada-approved with over 35 years of experience, specializing in custom chemical synthesis, cGMP API manufacturing, sterile vial filling, and formulation development including liposomal formulations. Dalton recently announced major expansion of its commercial sterile manufacturing capacity.

Danhson

Bulgaria

Danhson is a Bulgaria-based pharmaceutical holding company established in 2015, with group companies including Vetprom AD (65+ years of manufacturing history) and Danapha Pharmaceutical in Vietnam. The company develops, produces, and markets pharmaceutical products (Rx and OTC), food supplements, and cosmetics, with CMO/CDMO services. Danhson has invested BGN 50 million in a new production site with separate workshops for ampoule forms, liquid forms, semisolid, and biological products.

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.

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.

Galenicum Health

Spain

Galenicum Health is a Spanish specialty pharmaceutical company founded in 2003 in Barcelona, operating as a CDMO with a manufacturing facility near Madrid. The company produces finished dosage forms in multiple formats including liquids, ointments, creams, sachets, powders, nasal sprays, tablets, and capsules, with a production capacity of over 50 million packs per year. Galenicum operates in 58+ countries with 800+ employees and consolidated revenues of 213M EUR (2023).

Glenmark (incl. API arm Glenmark Life Sciences)

Argentina

Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company focused on branded and generic formulations, with an API manufacturing arm called Glenmark Life Sciences. The company manufactures APIs and finished dosage forms primarily for its own portfolio, spanning dermatology, respiratory, oncology, and cardiovascular therapeutic areas. Glenmark Life Sciences produces over 120 APIs across multiple manufacturing sites in India.

Granules (Granules India)

India

Granules India Limited is a vertically integrated pharmaceutical company and CDMO specializing in high-volume oral solid dosage manufacturing from APIs through finished dosage forms. The company is one of the largest manufacturers of core molecules such as paracetamol, metformin, guaifenesin, and ibuprofen, operating multiple FDA- and EU GMP-approved manufacturing facilities across India and the US. It provides contract manufacturing services for global pharmaceutical companies.

hameln rds s.r.o.

Slovakia

hameln rds s.r.o., based in Modra, Slovakia, is a well-recognized pharmaceutical CDMO that has been providing services to the healthcare industry since 1972. The company offers analytical and galenical development of pharmaceuticals, QC and laboratory services (including stability testing, batch release, and biologics testing), GMP production of APIs, and regulatory affairs support. It is FDA-registered with approved injectable products.

Hans Scientific

United States

HANS Scientific is a U.S.-based pharmaceutical contract manufacturing organization headquartered in Farmington Hills, Michigan, with a $2 billion investment in expanding its 27-acre manufacturing campus. The company specializes in fill/finish with terminal sterilization, aseptic fill and lyophilization, and Water for Injection (WFI) production using patent-pending technology. It features on-site QA/RA teams and in-house testing capabilities.

Help S.A. (HELP Pharmaceuticals)

Greece

HELP Pharmaceuticals is a Greek pharmaceutical company founded in 1971, operating an EU-GMP certified production facility in Ioannina, Greece. The company manufactures pharmaceuticals, medical devices, nutraceuticals, and cosmeceuticals across sterile and non-sterile lines, including solid, liquid, and semi-solid dosage forms. HELP serves partners in more than 50 countries and provides clinical manufacturing and packaging services.

Hitech Health

Ireland

HiTech Health is an Irish CDMO specializing in GMP sterile manufacturing for advanced therapies including cell and gene therapies. The company provides clinical-scale aseptic fill-finish of vials and bags, Qualified Person (QP) release services for EU and UK markets, regulatory support, and end-to-end supply chain management. HiTech Health recently opened a new advanced therapy manufacturing center in Galway, Ireland.

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.

Lannett CDMO

United States

Lannett CDMO is the contract development and manufacturing arm of Lannett Company, a generic pharmaceuticals company. Specializes in oral solid dose (OSD) and liquid formulations, including high-potency compounds and DEA-controlled substances. Operates a 425,000 sq ft cGMP-certified manufacturing facility in Seymour, Indiana with dedicated suites for potent drugs. Capabilities include technology transfers, modified release technology, complex formulations, and reformulation. Has over 100 product families currently in distribution. Acquired by Aurobindo Pharma USA Inc. for $250 million in July 2025. Revenue of $306 million in FY 2025.

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.

Meribel Pharma Solutions

France

Meribel Pharma Solutions is a mid-sized European end-to-end CDMO launched with 13 sites across France, Spain, and other European locations. The company specializes in sterile multidose products, sterile and non-sterile lyophilized products, API, sachets and stick packs, along with oral solid dose, liquid and semi-solid dosage forms. Meribel provides comprehensive services from development through commercialization including regulatory affairs, analytical development, process development, tech transfer, packaging, and manufacturing.

Microbiosci (Creative Biogene)

United States

Microbiosci (Creative Biogene) is a US-based biotech CDMO specializing in microbial fermentation-based production of commercial biological substances. The company provides GMP manufacturing services for recombinant proteins, recombinant pharmaceutical proteins, monoclonal antibodies, nucleic acid drugs, APIs, peptides, microbial metabolites, and enzymes. Their integrated platform includes strain development, fermentation process development, upstream/downstream processing, and fill-finish services.

Mikart, LLC

United States

Duplicate entry for Mikart, LLC -- same company as entries 16 and 17 (companyId a06bcecd and a06f4f1f). This is the same CDMO specializing in oral solid and non-sterile oral liquid dosage forms, headquartered in Atlanta, Georgia with 50+ years of experience, an FDA-registered facility, 82 approved products, and specialization in pediatric, geriatric, and controlled-substance formulations.

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.

NorthX Biologics

Sweden

NorthX Biologics is a Swedish CDMO specializing in advanced biologics and ATMPs (Advanced Therapy Medicinal Products). The company offers end-to-end services from process development to GMP manufacturing for recombinant proteins, viral vectors, plasmid DNA, cell therapy, extracellular vesicles, and mRNA. Recognized by the Swedish Government as an international competence center and innovation hub in 2021, NorthX has 30+ years of GMP manufacturing experience.

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.

Pharmaceutical Solutions Industry (PSI)

Saudi Arabia

Pharmaceutical Solutions Industry (PSI) is a leading injectable manufacturer in the Middle East and Africa, based in Saudi Arabia. The company manufactures standard IV solutions including dialysis solutions, pain management products, and large volume parenterals for the pharmaceutical industry.

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.

Rezon Bio

Poland

Rezon Bio is a European biologics CDMO headquartered in Poland, specializing in mammalian drug substance development and GMP manufacturing. The company operates two FDA-approved facilities with mirrored capabilities, employs approximately 1,300 people (10% PhDs), and has 16 years of biologics development experience. Rezon Bio offers end-to-end services from cell line development through commercial manufacturing with 2,000L bioreactors.

Rommelag CDMO GmbH (Rommelag Pharma Service)

Germany

Rommelag CDMO GmbH (Rommelag Pharma Service) is a German company that invented Blow-Fill-Seal (BFS) technology for aseptic packaging of liquid pharmaceutical products. The CDMO division provides contract filling services and product development support for liquid and semi-solid pharmaceutical products using BFS technology. Rommelag also manufactures the bottelpack BFS filling machines (up to 37,500 containers/hour) and provides comprehensive lifecycle services including qualification, validation, and factory planning.

Selkirk Pharma

United States

Selkirk Pharma is a US-based sterile fill/finish contract manufacturing organization (CMO) located in Spokane, Washington. Purpose-built by fill/finish industry experts, Selkirk offers liquid-filled vial manufacturing (0.5mL to 50mL) with fully automated isolator filling, achieving >99% yield. The facility is harmonized for GMP regulatory compliance with US FDA and EU Annex 1 standards, with capacity for both clinical trials and commercial-scale production.

SGS

Brazil

SGS Integrated CDMO Solutions is the contract development and manufacturing division of the global testing and inspection company SGS SA. Established in 2002 with a specialized UK-based CDMO site (MHRA and FDA inspected), SGS provides formulation development, API manufacturing, sterile fill/finish, lyophilization, and analytical services. A new 55,000 sq ft cGMP facility in Hudson, NH expands their North American capabilities across Phase I-III clinical trials and commercial supply.

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.

Siegfried Group

China

Siegfried Group is a leading global CDMO with 150+ years of pharmaceutical and chemical heritage, operating 13 production sites across Switzerland, Germany, Spain, France, Malta, the USA, and China. The company provides integrated services from early-phase API development through commercial-scale drug substance and drug product manufacturing, including exclusive synthesis, generic APIs, controlled substances, HPAPI handling, sterile formulations, and viral vector manufacturing through subsidiary DINAMIQS. In January 2026, Siegfried announced acquisition of additional US-based small molecule drug substance capacity.

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.

SmaBio Labs

United States

SmaBio Labs is a USA-based CDMO located in Research Triangle Park, North Carolina, delivering end-to-end drug development solutions from molecule discovery to market launch. They specialize in Chemistry Manufacturing and Control (CMC) services for small molecules, peptides, biologics, and complex APIs. Their capabilities include analytical services (IND/ANDA support, method development and validation, ICH stability testing, HPLC/UPLC, LC-MS, ICP-MS, NMR, XRPD), drug discovery and process development, API manufacturing (kg-scale cGMP), product development (formulation for oral solid dose, injectables, lyophilized products), and clinical trial material manufacturing (Phase I-III). FDA registered for analytical services. They support HPAPI compounds up to OEB 5.

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.

Solupharm GmbH

Germany

Solupharm Pharmazeutische Erzeugnisse GmbH is a German family-owned contract manufacturer specializing in sterile parenteral preparations in glass ampoules and glass vials since 1974. The company operates one of the most modern production facilities in Europe in Melsungen, Germany. Solupharm is FDA-registered as both an API and FDF manufacturer.

Srikem Laboratories Pvt Ltd

India

Srikem Laboratories Pvt Ltd is an Indian pharmaceutical company based in Navi Mumbai (MIDC Taloja industrial area) that manufactures active pharmaceutical ingredients. Search results indicate they supply APIs including Clotrimazole and antibacterials for systemic use. No website text was available. They are listed on PharmaSource and appear in a Global Business Reports feature on India Pharmaceuticals as investing in R&D and manufacturing capabilities. Limited information prevents a more detailed classification, but evidence points to API manufacturing rather than contract drug product manufacturing.

Swiss Parenterals Limited

India

Swiss Parenterals Limited is an Indian pharmaceutical manufacturing company producing tablets, capsules, injections, and sterile eye preparations. The company has integrated with Eris Lifesciences Limited and operates as a CDMO/CMO partner. The company manufactures across a wide range of dosage forms and technologies, including parenteral drug products and oral solid dosage forms.

Synokem Pharmaceuticals Ltd

India

Synokem Pharmaceuticals Ltd is one of India's largest CDMOs, backed by TA Associates investment (2023). The company specializes in contract development and manufacturing, ethical marketing, and pharmaceutical exports. Synokem acquired Nitin Lifesciences Ltd and Parabolic Drugs Ltd to expand API production capacity. The company recently launched a modernized cephalosporin injectable manufacturing block for commercial production. Synokem's website is currently suspended but the company remains operational and expanding.

The Vanguard Utility Corporation

United States

US-based company using next-generation Blow-Fill-Seal equipment and prefabricated robotic packaging lines to fill-finish generic injectable medicines. Operational subsidiary of ApiJect. Two business approaches: (1) producing compounded pharmaceutical products for the US market through its Global Pharmacy Reserve division, and (2) licensing prefabricated fill-finish lines with their technology to pharma companies globally (Pharmaceutical Reserve Network). Focused on addressing drug shortages of generic injectables. Headquartered in Stamford, CT with operations in Newtown, PA. FDA-registered with 1 NAI inspection.

Torbay Pharmaceuticals (Torbay Pharma)

United Kingdom

Torbay Pharma is a UK-based global CMO and licence holder specializing in contract manufacturing of terminally sterilized generic injectables. The company partners with the world's best-known pharmaceutical companies to manufacture and supply sterile injectable products to more than 20 countries. Services include sterile fill-finish (ampoules, glass/plastic vials, oral syringes), QP certification, labeling/packaging, TPN compounding, and product safety.

Trident Lifeline Limited

India

Trident Lifeline Limited is an Indian pharmaceutical company established in 2014, engaged in manufacturing and marketing finished dosage forms. The company offers contract manufacturing services (hybrid model: own products + third-party manufacturing) for tablets, capsules, dry powder, liquid, ointment, gel, and injectable products. WHO-GMP compliant with global presence in 40+ countries. 3133+ products registered with India FDA, 989+ globally registered products.

Vianex S.A.

Greece

Vianex S.A. is a prominent Greek pharmaceutical company listed on PharmaSource as a CDMO. The company is described as specializing in contract development and manufacturing. While the website content is primarily in Greek and could not be fully parsed, PharmaSource confirms CDMO services. The company appears to have multiple manufacturing facilities (Factory A, B, C, D mentioned in navigation) and covers a broad range of dosage forms. Founded by Paul J. Giannacopoulos.

Vioser SA

Greece

Vioser S.A. is a Greek pharmaceutical company established in 1984 in Trikala, Greece, specializing in IV (intravenous) solution manufacturing. The company operates under GMP and offers contract manufacturing of IV solutions including custom product development. Expanding international business in Europe, Asia, and Africa. Contract manufacturing is described as a cornerstone of their strategy, with heavy investment in manufacturing facilities. Covers the full IV solution business from initial product idea to final delivery.

VUAB Pharma a.s.

Czech Republic

VUAB Pharma a.s. is a traditional Czech pharmaceutical manufacturer with over 75 years of experience, specializing in contract development and manufacturing of APIs and finished dosage forms. Part of the SAFICHEM group, the company operates multiple production centers including API manufacturing in Roztoky u Prahy, API in Brno, and biotechnology in Ceske Budejovice. VUAB is FDA-registered for API manufacturing.

Advaxia Biologics is a CDMO near Rome, Italy, specializing in adenovirus vaccine development and cGMP manufacturing. With over 10 years of biologics expertise and a 100% batch approval rate, Advaxia provides fully integrated services from expression systems and process development to analytical development and GMP manufacturing, and is EMA, FDA, and AIFA compliant.