Sterile Injectable CDMOs

Egis Pharmaceuticals PLC

Hungary

Egis Pharmaceuticals PLC is a Hungarian generic pharmaceutical company with over 110 years of history, now offering CDMO services through its Egis Pharma Services division. The company operates three production sites in Hungary (two in Budapest, one in Kormend) and manufactures APIs, tablets, injections, and galenic formulations including ointments, suppositories, and syrups. Egis specializes in highly potent API development and manufacturing using organic chemical synthesis on GMP-compliant multi-functional lines for oncology and rheumatic arthritis therapies.

Emcure Pharmaceuticals Limited

India

Emcure Pharmaceuticals Limited is a leading Indian pharmaceutical company and CDMO founded in 1981, headquartered in Pune, India, with operations spanning over 70 countries. Originally established as a CDMO, Emcure now operates 14 manufacturing facilities (including US FDA-approved sites) producing APIs, oral solid dosage forms, injectables (including liposomal and lyophilized), biotherapeutics, and vaccines. The company specializes in complex generics, chiral molecules, high-potency APIs, and novel drug delivery systems including lipid nanoparticles and long-acting injectables.

Emergent BioSolutions

Canada

Emergent BioSolutions is a specialty life sciences company with CDMO capabilities, though it has been actively pivoting away from its CDMO business. The company has sold its Baltimore-Bayview drug substance facility to Syngene and its Baltimore-Camden sterile fill/finish facility to Bora Pharmaceuticals. Emergent retains four manufacturing facilities across North America (US and Canada) and holds FDA registrations, 6 approved products, and has conducted 5 clinical trials in infectious disease. The company previously invested $75M in viral vector and gene therapy capabilities at its Canton site.

Ethypharm

China

Ethypharm is a leading mid-size international specialty pharmaceutical company and CDMO with 5 manufacturing plants across France, UK, and Spain. The company specializes in oral solid dosage forms, sterile injectables in ampoules, pre-filled syringes and IV bags, with particular expertise in high potent APIs and controlled substances including opioids and psychotropics.

Fresenius Kabi iPSUM S.r.l.

Italy

Fresenius Kabi iPSUM S.r.l. is the Italian subsidiary of Fresenius Kabi, a global healthcare company with significant CDMO operations specializing in lifesaving medicines for critically and chronically ill patients. The company has extensive FDA-registered manufacturing facilities with 405 FDA-approved products, and provides contract development and manufacturing services for injectable, infusion, and other sterile pharmaceutical products.

Gland Pharma

Belgium

Gland Pharma is one of the largest generic injectable manufacturing companies globally, established in Hyderabad, India in 1978. The company operates under a B2B/CDMO business model with four cGMP-compliant formulation facilities and four API facilities, supplying products across 60 countries. It focuses on sterile injectables, oncology, and ophthalmics, including complex injectables and 505(b)(2) filings.

Grifols (Grifols Partnership)

Spain

Grifols Partnership is the CDMO arm of Grifols, a Spanish multinational with over 100 years of pharmaceutical experience, specializing in added-value small molecule injectable products manufactured in flexible bags and vials. The company operates FDA-approved manufacturing facilities and serves mid-size, large, and generic pharmaceutical companies with sterile parenteral drug products, including terminal sterilization and Form-Fill-Seal processes.

Gufic Biosciences Ltd

India

Gufic Biosciences Ltd is an Indian pharmaceutical company established in 1970, recognized as one of the largest manufacturers of lyophilized injections in India. The company operates a fully automated lyophilization plant and offers CMO/CDMO services for lyophilized injectables across antibiotic, antifungal, cardiac, infertility, antiviral, and proton-pump inhibitor segments.

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.

Hangzhou Jiuyuan Gene Engineering Co., Ltd

China

Hangzhou Jiuyuan Gene Engineering Co., Ltd., a subsidiary of Huadong Medicine Co., Ltd., is a Chinese biopharmaceutical company that was among the first national high-tech enterprises to realize biopharmaceutical manufacturing. The company produces finished dosage forms including oncology injections and is FDA-registered. It operates as part of the larger Huadong Medicine group which includes Doer Biologics.

Hanmi Pharm. Co. Ltd

South Korea

Hanmi Pharmaceutical is a major South Korean pharmaceutical company providing comprehensive CDMO services across the entire pharmaceutical lifecycle. The company operates through Paltan Smart Plant (producing 6+ billion chemical drug tablets annually), Pyeongtaek Bioplant (FDA-approved biopharmaceutical manufacturing with 12,500L bioreactors), and Hanmi Fine Chemical (API and raw materials including mRNA cap analogs, NTP, and lipids). Hanmi has partnerships with global pharma companies including Lilly, Roche, and Sanofi.

Hebei Changshan Biochemical Pharma Co. Ltd

China

Hebei Changshan Biochemical Pharmaceutical Co., Ltd., founded in 2000, is a leading Chinese manufacturer of heparin and related products. The company has a complete heparin industry chain from crude products to APIs to finished injectable preparations, including heparin sodium APIs, low molecular weight heparin calcium injections, and sodium hyaluronate.

Hikma Pharmaceuticals

Algeria

Hikma Pharmaceuticals is a global pharmaceutical company with 29 manufacturing plants across the US, Europe, and MENA, producing injectable, oral, and respiratory medicines. The company offers CMO services and has announced a $1 billion investment by 2030 to expand US manufacturing and R&D capabilities. Hikma has 76 FDA-approved products, produces 500 million injectable units annually, and has maintained zero critical FDA observations in 20+ years.

HIPRA Biotech Services

Spain

HIPRA Biotech Services is the CDMO division of HIPRA, a Spanish biopharmaceutical company with over 50 years of experience in vaccine research, production, and commercialization. The CDMO unit offers comprehensive biologics contract development and manufacturing services across mammalian, avian, and insect cell culture, microbial fermentation (E. coli, yeast), and aseptic fill-and-finish. HIPRA has experience with over 300 biological entities and demonstrated rapid development capability during COVID-19 vaccine production.

Hiral Labs Ltd

India

Hiral Labs Ltd is an Indian pharmaceutical contract manufacturer established in 2000, based near Roorkee, Uttarakhand. The company operates two WHO-GMP and ISO-certified manufacturing sites producing liquid injections, tablets, capsules, ointments, syrups, eye/ear drops, and oncology injections (including lyophilized). Hiral Labs manufactures over 350 formulations on a contractual basis for more than 300 companies across approximately 4,000 brands.

Huons Co., Ltd.

South Korea

Huons Co., Ltd. is a South Korean global total healthcare company that develops, manufactures, and markets pharmaceutical products including anesthetics, eye drops, diabetes treatments, and dermatological products. The company has FDA-approved injectable products and operates manufacturing facilities with multiple subsidiaries.

IBSA Institut Biochimique SA

Italy

IBSA (Institut Biochimique SA) is a Swiss multinational pharmaceutical company founded in 1945 in Lugano, with products present in over 90 countries. The company develops and manufactures innovative pharmaceutical products across 10 therapeutic areas with proprietary drug delivery technologies, including oral films, patches, and gonadotropin purification processes. IBSA has FDA-approved products in multiple dosage forms.

IDT Biologika

Germany

IDT Biologika is a leading global biologics CDMO headquartered in Germany, specializing in end-to-end development and manufacture of viral vaccines, gene and immune therapeutics, and aseptic fill-finish of sterile injectables. Founded in 1921 with over a century of experience in vaccines, the company operates BSL-2 facilities and has completed over 200 development, clinical, and commercial projects. IDT Biologika is a subsidiary of SK bioscience.

i+Med S. Coop.

Spain

i+Med S. Coop. is a Spanish pharmaceutical cooperative of scientists dedicated to the development, manufacture, and marketing of injectables, drug products, cosmetics, nutraceuticals, and medical devices. The company offers CDMO services with expertise in controlled release technologies, nanohydrogels, and nanocarriers, supporting clients from initial development through commercial manufacturing.

Insud Pharma

Argentina

Insud Pharma is a large, diversified Spanish multinational pharmaceutical group with over 45 years of experience, 10,000 professionals, and 20 industrial plants across more than 50 countries. The company operates API manufacturing, oral solid dose, and injectable manufacturing through its CMO division (Chemo CMO), and biologics/biosimilar manufacturing through its biotech unit mAbxience (majority stake sold to Fresenius Kabi in 2022).

Intas Pharmaceuticals

India

Intas Pharmaceuticals is a leading vertically integrated pharmaceutical company headquartered in Ahmedabad, India, with CDMO capabilities spanning API manufacturing through finished formulations. The company operates 14 manufacturing facilities globally (11 in India, plus UK and Mexico), serving 85+ countries with particular strength in oncology, biosimilars, and plasma-derived therapies. Its flagship Pharmez 2 facility can produce over 1 billion solid oral units monthly and 5 million injectable units.

JCR Pharmaceuticals

Japan

JCR Pharmaceuticals is a Japanese pharmaceutical company and CDMO founded in 1975, with nearly 50 years of experience in rare disease treatments and orphan drug production. Selected for Japan's Regenerative Medicine CDMO Subsidy Program in 2025, the company is expanding biomanufacturing infrastructure for cell, gene, and regenerative medicine therapies. JCR operates five production sites and has proprietary platforms including JUST-AAV for gene therapy and J-Brain Cargo for blood-brain barrier penetration.

Jiangsu Nhwa Pharmaceutical Co., Ltd.

China

Jiangsu Nhwa Pharmaceutical Co., Ltd. is a leading Chinese pharmaceutical company specializing in CNS (Central Nervous System) drugs, listed on Shenzhen Stock Exchange (002262.SZ) since 2008. Founded in 1978, the company is designated as a national production unit for narcotic and psychotropic drugs. Nhwa operates over 10 automated production lines for tablets, capsules, liquid injectables, and powder injectables, covering over 800 acres. The company serves as a major global CNS drug production and R&D base.

Liof Pharma

Spain

Liof Pharma is a European CDMO headquartered in the Basque Country, Spain, specializing in aseptic manufacturing and lyophilization of sterile injectable biologics. With over 15 years of experience, the company provides clinical and commercial manufacturing of biologics drug products including monoclonal antibodies, peptides, proteins, mRNA, AAV viral vectors, and vaccines. The facility operates in compliance with EMA, FDA, ANVISA, and AEMPS regulations.

Lomapharm GmbH

Germany

Lomapharm GmbH is a German pharmaceutical contract manufacturer with 140+ years of experience (since 1878), offering services from development through production and packaging to market release. The company produces solid oral dosage forms (including micro-tablets) and aseptically manufactured sterile dosage forms such as preservative-free eye drops and nasal sprays. Lomapharm was formerly a subsidiary of Daicel Corporation before being transferred to Bionorica SE.

Lonza

Switzerland

Lonza is a pioneer and world leader in the CDMO industry, founded in Switzerland in 1897. The company provides integrated development and manufacturing services across biologics, small molecules, cell and gene therapy, mRNA, and bioconjugates (ADCs/HPAPIs). With over 20,000 employees across five continents, Lonza serves the global pharmaceutical, biotech, and nutrition industries with end-to-end capabilities from early development to commercial-scale manufacturing.

Medichem S.A.

Malta

Medichem S.A. is a family-owned, vertically integrated pharmaceutical company headquartered in Barcelona, Spain, with nearly 50 years of industry experience. The company delivers end-to-end solutions from API development to finished drug product manufacturing (oral and injectable). Their portfolio includes approximately 45 APIs and 20 finished dosage forms (FDF), supported by full regulatory dossiers. Medichem provides API and FDF CDMO solutions and is also a leader in antiseptic products. The company has 400 experienced professionals serving 600+ corporate customers across 60+ countries. Facilities include R&D centres in Barcelona, Celra, and Hal-Far (Malta), and manufacturing plants in Celra (Spain), Hal-Far (Malta), and a new sterile injectables facility in Llanera, Asturias (Medichem Solutions). Medichem also has commercial offices in New York and Nanjing.

MERRYMED FARM LLC

Uzbekistan

MERRYMED FARM LLC is an Uzbekistan-based pharmaceutical manufacturer. Based on CPHI listings, the company produces finished dosage forms including heparin solutions for injection, and products in cardiovascular, respiratory, gastrointestinal, and other therapeutic categories. The company appears to be a commercial pharmaceutical manufacturer rather than a full-service CDMO with development capabilities.

Milan Laboratories (India) Pvt. Ltd.

India

Milan Laboratories (India) Pvt. Ltd. is an Indian pharmaceutical manufacturer and exporter established in 1976, producing and exporting pharmaceutical formulations from WHO-cGMP compliant facilities. The company has 300+ marketing authorizations across 43+ countries. Milan has 9 FDA-registered FEI numbers, 65 FDA-approved products across multiple dosage forms (tablets, injectables, liposomal injectables, solutions, emulsions, powders), and has received 38 FDA inspections (14 NAI, 19 VAI, 5 OAI). The company has also had 16 Class II recalls. Milan provides regulatory consulting services and dossier preparation in ACTD, CTD, eCTD formats.

MSN Laboratories

India

MSN Laboratories is a Hyderabad-based major pharmaceutical CDMO with $1.2 billion in revenue. The company operates 15 API facilities and 6 finished dosage form (FDF) facilities across India and the USA (Novadoz Pharmaceuticals). MSN offers CRAMS (Contract Research and Manufacturing Services) with 200+ first-to-market generics and 400+ formulations. Specialized capabilities include cytotoxics, high-potency APIs, peptides, prostaglandins, and biosimilars. FDA-registered with 14 FEI numbers, 31 FDA inspections (16 NAI, 15 VAI — strong track record), and 119 FDA-approved products. Has established an advanced E&L (Extractables and Leachables) Laboratory.

Nephron

United States

Nephron Pharmaceuticals is a US-based sterile pharmaceutical manufacturer and 503B outsourcing facility headquartered in West Columbia, South Carolina. The company specializes in generic respiratory medications (inhalation solutions and suspensions) and contract manufacturing of sterile pre-filled medications using blow-fill-seal (BFS) technology, producing over one billion doses annually.

NerPharMa srl (NMS Group)

Italy

NerPharMa is an Italian CDMO (part of NMS Group, acquired by Benta in 2026) specializing in highly potent compounds with strong expertise in oncology. It operates two divisions: Drug Substance (API manufacturing in high containment glove-box suites, 50-250L reactors, 0.5-5 kg batches) and Drug Product (injectable solutions, suspensions, lyophilized products, and oral solid dosage forms including cytotoxic and cytostatic products).

Nobel Ilac Sanayii Ve Ticaret A.S.

Kazakhstan

Nobel Ilac is a Turkish pharmaceutical company founded in 1964, operating in 20+ countries with representative offices and exporting drug substances and drug products to over 50 countries. The company manufactures both APIs and finished dosage forms, with biotechnology as a declared strategic priority. It is listed as a CMO/CDMO on PharmaSource with contract small molecule API manufacturing capabilities.

NorthStar Medical Radioisotopes, LLC

United States

NorthStar Medical Radioisotopes is a US-based commercial-stage company focused on the development, production, and commercialization of radiopharmaceuticals. Operating a dedicated Radiopharmaceutical CDMO/CMO on its 55-acre Beloit, Wisconsin campus, NorthStar develops novel non-reactor-based production processes for therapeutic and diagnostic radioisotopes including Molybdenum-99, Copper-67, and Actinium-225. The company has 14 FDA-approved products and a 52,000 sq ft purpose-built CDMO 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.

Novell Pharmaceutical Laboratories

Indonesia

Novell Pharmaceutical Laboratories is one of the largest pharmaceutical companies in Indonesia, manufacturing both oral solid dosage forms (tablets, capsules, powders) and sterile injectable products (liquid and powder). The factory was originally built and operated by a multinational company, and later expanded to Australian TGA standards. The facility features Class A/B/C/D cleanrooms, Bausch & Stroebel filling equipment, Getinge autoclaves, and Lytzen depyrogenation ovens. Novell has 2 FDA-registered FEI numbers, 3 FDA-approved products, and 10 FDA inspections.

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.

Novugen Pharma

Malaysia

Novugen Pharma is a Malaysian pharmaceutical company and CDMO subsidiary of UAE-based SciTech International, providing vertically integrated API and finished dosage form development and manufacturing. The company has USFDA-approved facilities including a dedicated oncology manufacturing plant. Novugen achieved zero Form 483 citations from USFDA and holds Halal pharmaceutical certification.

Nucleus RadioPharma

United States

Nucleus RadioPharma is a US-based full-service CDMO dedicated to building clinical and commercial supply chains for targeted radiotherapies (radiopharmaceuticals). The company operates a cGMP-compliant facility in Rochester, MN with expansion sites under construction in Spring House, PA and Mesa, AZ, targeting over 100,000 square feet of purpose-built radiopharmaceutical development and manufacturing space.

Orofino Pharmaceuticals Group

Italy

Orofino Pharmaceuticals Group (OPG), headquartered in Rome, Italy, is a group of companies specializing in third-party pharmaceutical manufacturing services. The group includes Biopharma (betalactam finished products), Injectalia (small sterile liquids including hormones, biologicals, heparins, vaccines), K24 Pharmaceuticals (chemical testing, EU release, secondary packaging), and Drug'On Pharma Switzerland (API manufacturing). Focused on sterile injectables and betalactam oral/injectable dosage forms.

Pace® Life Sciences

United States

DUPLICATE ENTRY -- This is the same company as 'Pace Analytical Services LLC (Pace Life Sciences)' (company index 10). Pace Life Sciences is the CDMO/CRO division of Pace Analytical. Same website content, same capabilities. See company index 10 for full profile.

PCI Pharma Services

Australia

PCI Pharma Services is a global CDMO providing fully integrated drug development, manufacturing, clinical trial services, and commercial packaging solutions. With over 8,000 employees in 38 GMP facilities worldwide, PCI offers services spanning sterile fill-finish, lyophilization, oral solid dose manufacturing, complex formulations, and advanced drug delivery including drug-device combination products.

PENMIX Co. Ltd.

South Korea

PENMIX is Korea's largest CDMO, fully committed to globalization of the pharmaceutical industry. The company operates dedicated penicillin manufacturing and general injection manufacturing plants with KGMP and FDA registration. PENMIX provides contract manufacturing services for penicillin formulations (tablets, injections) and sterile injectable products including lyophilized vials, liquid vials, ampoules, and pre-filled syringes, with full automation lines conforming to PICS GMP guidelines.

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.

Pharmaron

China

Pharmaron is a premier life science CRO/CDMO providing comprehensive R&D and manufacturing services across the entire drug discovery to commercialization process. The company serves small molecules, biologics, ADCs, cell & gene therapies, and protein degraders. It offers laboratory services, chemistry/manufacturing/controls (CMC), clinical development, and biologics/CGT manufacturing. Pharmaron acquired a commercial API manufacturing facility in the UK and operates a gene therapy CDMO in Liverpool with a 20-year track record. The company has over 20 years of experience across 7+ facilities in the UK, US, and China.

Pharmascience

Canada

Pharmascience is Canada's largest privately-owned pharmaceutical company, a leading manufacturer of generic, branded, and over-the-counter pharmaceuticals. The company has recently expanded its CDMO services with a new commercial business unit, investing over $120 million to expand its sterile injectable manufacturing facility in Candiac, Quebec, aiming to more than triple capacity. Pharmascience's ambition is to become a world leader in the sterile injectable CDMO segment. The company distributes products in over 50 countries and invests approximately $65 million per year in R&D in Canada. The Pendopharm division offers specialty medicines in gastroenterology, orthopedics, and neurology.

Pharmathen

Greece

Pharmathen is a Greek research-centred CDMO specializing in complex drug delivery and formulation development. Founded in 1969 and acquired by Partners Group for $1.89 billion, the company operates two state-of-the-art manufacturing facilities: Rodopi (FDA-approved, 15,300 m2, capacity 3.3 billion tablets, 1.2 billion capsules, 175 million blisters, 4 million sterile syringes/vials) and Pallini/Attica (4,000 m2, 800 million tablets/capsules, 1.5 million sterile vials, 6 million ampoules). Pharmathen has also acquired CBL Patras. Key technology platforms include Long Acting Injectables (biodegradable microparticles, nanosuspensions, self-assembled nanogel systems), modified release oral formulations, preservative-free ophthalmic formulations, and solubility/permeability enhancement technologies.