Sterile Injectable CDMOs

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.

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.

Fisiopharma

Italy

Fisiopharma is an Italian CDMO established in 1989, dedicated to the development and manufacturing of injectable pharmaceutical products in the form of liquid, suspension, and lyophilized formulations. It offers CDMO services from first product development through to commercial manufacturing at its facility in Italy.

Global Pharma HealthCare (India)

India

Global Pharma HealthCare is an Indian pharmaceutical CDMO offering contract development and manufacturing services for sterile and non-sterile dosage forms. The company provides end-to-end services from formulation development through commercial manufacturing, including oral solids, liquids, sterile injectables, and lyophilized products. It serves regulated markets including the US, EU, and other global markets.

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.

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.

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.

LABIANA

Spain

LABIANA is a Spanish pharmaceutical group founded in 1958 with over 60 years of history, now listed on BME Growth. They operate as a CDMO serving both human and veterinary pharmaceutical sectors. LABIANA has three EU-GMP manufacturing plants: Labiana Pharmaceuticals in Corbera de Llobregat (Barcelona) for human pharma with sterile liquids, non-sterile liquids, and non-sterile solids; and Labiana Life Sciences in Terrassa (Barcelona) plus Veterinarski Zavod Subotica in Serbia for veterinary products including biologicals (viral, bacterial, and autogenous vaccines). The company is a benchmark in contract manufacturing for sterile forms and also manufactures/distributes Fosfomycin Trometamol under its own brand. Their subsidiary Zoleant Pharmaceuticals handles global marketing of niche alternative brand medicines.

Laboratório Edol, S.A.

Portugal

Laboratorio Edol, S.A. is a Portuguese pharmaceutical company specializing in development, manufacturing, and marketing of medicines, medical devices, cosmetics, and food supplements, with a focus on Ophthalmology, Dermatology, Otorhinolaryngology, and Dermocosmetics. They operate from their factory in Linda-a-Velha, Portugal and offer contract manufacturing (producao para terceiros) services across a wide range of pharmaceutical forms including small and large volume injectables, gels, creams, ointments, syrups, oral solutions and suspensions, cutaneous solutions, and enemas. They have two industrial units equipped for third-party manufacturing.

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.

MAKCUR LABORATORIES LTD.

India

MAKCUR LABORATORIES LTD. is an Indian pharmaceutical manufacturer specializing in small volume parenterals (liquid vials/ampoules), powder injections, and ophthalmic/otic drops. The company manufactures a range of finished dosage forms including antibiotics, anti-inflammatory, antifungal, and ophthalmic preparations. Products include branded formulations in eye/ear drops, liquid injections, and topical preparations. Located in Naroda-Dehgam, Gujarat, India.

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.

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.

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.

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.

QuVA Pharma

United States

QuVA Pharma is a US-based FDA-registered 503B outsourcing facility specializing in sterile compounding of ready-to-administer injectable medicines for hospitals. They serve over 3,000 US hospitals and operate multiple manufacturing and forward distribution centers. They also offer AI-powered analytics (Quva BrightStream) for health-system pharmacy data insights. Notable regulatory history includes multiple OAI inspections and Class I/II recalls.

Recipharm AB

Sweden

Rechon Life Science AB is a subsidiary/entity within the Recipharm group, the global CDMO headquartered in Stockholm, Sweden. This entry represents the same Recipharm organization (same website: recipharm.com) with its extensive global manufacturing footprint of 15+ FDA-registered FEI numbers and 52 FDA inspections. The Perplexity research confirms Recipharm's specialization in oral solid dose, inhalation, sterile manufacturing, and HPAPI capabilities. Rechon may represent a specific Recipharm site or legacy entity. Duplicate of Recipharm AB entry -- capabilities are identical.

REMEDICA LTD

Cyprus

REMEDICA is a Cyprus-based pharmaceutical manufacturer that has been operating for over four decades, distributing products in more than 160 countries. They manufacture generics across multiple therapeutic areas and dosage forms (solid oral dose, liquids, semi-solids, sterile injectables) and offer contract manufacturing (CMO/CDMO) services. They have long-standing relationships with NGOs (UNICEF, WHO, UNRWA). They focus on B2B partnerships, own-brand commercialization (Cyprus, Eastern EU, Asia, Middle East, Africa, LATAM), and NGO supply.

Sandoz

Austria

Sandoz is a global leader in generic and biosimilar medicines, spun off from Novartis in 2023 as a standalone company. It manufactures and markets generic pharmaceuticals and biosimilars but operates as a branded pharmaceutical company, not a contract manufacturer for third parties.

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.

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.

Xedev

Belgium

Xedev is a flexible CDMO based in Belgium, specialized in formulation and process development for oral solid dosage forms. They offer early-phase development services including spray drying, hot melt extrusion, amorphous solid dispersions, and GMP clinical manufacturing for Phase I and Phase II batches.