Sterile Injectable CDMOs

Boehringer Ingelheim Biopharmaceuticals GmbH (BioXcellence)

Germany

Boehringer Ingelheim BioXcellence is the contract biopharmaceutical manufacturing arm of Boehringer Ingelheim, one of the world's largest pharmaceutical companies. BioXcellence offers end-to-end biologics CDMO services including mammalian cell culture, microbial fermentation, viral vector production, and aseptic fill/finish with extensive FDA, EMA, and PMDA regulatory approvals across multiple global facilities.

Bora Biologics

United States

Bora Biologics is a biologics-focused CDMO based in the United States offering contract development and manufacturing services for monoclonal antibodies, recombinant proteins, and other biologic drug substances and drug products. The company provides end-to-end biologics services from cell line development through cGMP manufacturing, analytical testing, and aseptic fill/finish.

Bora Pharmaceutical

Canada

Bora Pharmaceuticals is a global CDMO headquartered in Canada with manufacturing facilities across North America and Asia. The company offers comprehensive contract development and manufacturing services for oral solid dosages, sterile injectables, topicals, and liquids, serving both clinical and commercial supply needs with FDA and EMA approved facilities.

Boston Institute of Biotechnology (BIB)

United States

Boston Institute of Biotechnology (BIB) is a US-based full-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy services. The company features the world's first ultra-large bioreactor with 30,000L working volume capacity and provides end-to-end services from cell line development through commercial-scale cGMP manufacturing.

Bryllan

United States

Bryllan is a US-based CDMO specializing in the production and filling of potent and cytotoxic compounds, with a focus on aseptic powder and liquid filling for complex drug and device combination products. The company operates a high-containment, state-of-the-art facility in Brighton, Michigan, supporting both clinical and commercial supply of ADCs and other cytotoxic products.

BSP Pharmaceuticals

Italy

BSP Pharmaceuticals is an Italian CDMO specializing in cytotoxic, ADC (antibody-drug conjugate), and non-cytotoxic sterile injectable manufacturing. The company provides development, clinical, and commercial supply services including API synthesis, ADC conjugation and fill/finish, and oral solid dose manufacturing, with FDA and EMA approved facilities near Rome.

Cadila Pharmaceuticals Ltd

India

Cadila Pharmaceuticals Ltd is one of India's largest privately-held pharmaceutical companies, operating as both a branded generics company and CDMO/CMO. The company covers the entire life science value chain including R&D, API manufacturing, formulations across 45 therapeutic segments, drug discovery, and contract manufacturing services including vaccines.

Cambrex

Canada

Halo Pharmaceuticals, acquired by Cambrex in 2018 for $425 million and later sold to SK Capital Partners in 2023, is a drug product CDMO specializing in oral solids, liquids, creams, sterile and non-sterile ointments, complex formulations, pediatric indications, and controlled substances. The company operates 430,000 square feet of GMP-compliant manufacturing space across Whippany, New Jersey and Montreal, Quebec, serving over 85 clients.

Canton Biologics Co., Ltd.

China

Canton Biologics Co., Ltd. is a biologics CDMO founded by Chinese returnee scientists at Guangzhou International Biological Island. The company provides integrated R&D and manufacturing services for biologics including CMC development, GMP manufacturing up to 2000L, analytical development, and aseptic fill/finish with GMP certifications from China, US, Japan, and Europe.

CARBOGEN AMCIS

CHina

CARBOGEN AMCIS is a leading CDMO offering drug substance and drug product development and manufacturing services from early development through commercialization. Part of the Indian Dishman Carbogen Amcis group, the company has facilities in Switzerland, France, UK, Netherlands, and China, specializing in complex small molecule APIs, ADC payloads, and sterile drug products.

Catalent Pharma Solution

Argentina

Catalent is a leading global CDMO trusted by pharma, biotech, and self-care companies to accelerate the development, manufacturing, and delivery of products that improve lives. With a worldwide network of facilities, advanced technologies, and deep expertise, Catalent provides integrated end-to-end solutions spanning oral dose, biologics, specialty therapies, cell and gene therapy, and clinical supply. The company partners with innovators from early-stage design through commercial manufacturing.

Celltrion

South Korea

Celltrion is a major South Korean biopharmaceutical company offering CDMO services for biologics, biosimilars, and small molecules. The company operates production capacities from 1,000L to 15,000L with a 98.5% batch success rate across 2,100+ cGMP drug substance batches, holding 400+ regulatory approvals in 90+ countries. Celltrion recently acquired Eli Lilly's Branchburg, New Jersey facility and launched Celltrion BioSolutions as a dedicated CDMO subsidiary, with plans to expand DS capacity to 132,000L by 2030.

Chemwerth

China

ChemWerth is a US-headquartered, family-owned full-service generic API development and supply company established in 1982. The company provides end-to-end services including new product development, compliance auditing, regulatory filing (500+ DMFs filed globally), and CMO management across 30+ FDA-approved manufacturing facilities in the US, Europe, India, and China. ChemWerth offers the CATALYST program for comprehensive API development and manufacturing.

Chime Biologics

China

Chime Biologics is a leading global CDMO focused on biologics and biosimilars, offering end-to-end services from cell line development through drug substance and drug product manufacturing. The company pioneered modular facilities with single-use bioprocessing technology and has partnerships with companies like MedPacto and Polpharma Biologics.

C.O.C. Farmaceutici Srl

Italy

C.O.C. Farmaceutici Srl (Content Group) is an Italian pharmaceutical CDMO specializing in contract development, manufacturing, and filling of liquid, gel, and lyophilized pharmaceuticals, medical devices, and cosmetics. The company operates three production plants in Italy (Sant'Agata Bolognese, Rovereto sul Secchia, and Pomezia) with 500+ employees, generating 108.3 million euros in turnover in 2025, with particular expertise in ophthalmic and respiratory products. The Pomezia facility (Tubilux Pharma) is FDA approved.

Concord Biotech

India

Concord Biotech Limited is a leading Indian biopharmaceutical company specializing in fermentation-based API manufacturing and formulations. With over 25 years of expertise, the company manufactures 30+ APIs across immunosuppressants, oncology, and anti-infective therapeutic areas, serving 250+ global customers in 70+ countries. Concord operates four manufacturing facilities in Gujarat, India, including a new injectable manufacturing facility at Valthera producing liquid and lyophilized dosage forms.

Continuus Pharmaceuticals

United States

Continuus Pharmaceuticals is a pioneering CDMO based in Woburn, Massachusetts, specializing in Integrated Continuous Manufacturing (ICM) technology for small-molecule pharmaceuticals. The company replaces traditional batch processes with end-to-end continuous manufacturing, transforming raw materials into APIs and finished dosage forms in days rather than months. Continuus has received FDA and BARDA partnerships and a $69.3M DoD grant, and is building a $125 million manufacturing facility in Woburn.

CreoSalus

United States

CreoSalus Inc. is a Louisville, KY-based cGMP CDMO specializing in custom peptide synthesis, process development, and manufacturing of peptide drug substances (API) and sterile injection drug products. The company has pioneered personalized peptide cancer vaccine manufacturing since 2016, producing thousands of personalized peptide vaccines for clinical trials with a 100% patient order success rate.

CuraTeQ Biologics

India

CuraTeQ Biologics is an EU GMP-certified biopharmaceutical CDMO based in Hyderabad, India, and a subsidiary of Aurobindo Pharma. The company specializes in biosimilar development and manufacturing with a focus on oncology and immunology therapies, including monoclonal antibodies. CuraTeQ has filed multiple biosimilars with EMA and is building CDMO capabilities for contract biologics manufacturing.

Curida

Norway

Curida is a European CDMO headquartered in Oslo, Norway with over 50 years of GMP experience, specializing in biologics and liquid pharmaceutical formulations. The company offers contract development and manufacturing for monoclonal antibodies, nasal sprays, ophthalmic products, and sterile/non-sterile liquids using Blow-Fill-Seal technology. Curida operates multiple GMP-certified sites across Norway serving 40+ global partners.

Daewoong Pharmaceutical Co., Ltd. (Daewoong Bio)

South Korea

Daewoong Pharmaceutical is a major South Korean pharmaceutical company whose subsidiary Daewoong Bio provides CMO services for biopharmaceutical manufacturing. Daewoong Bio opened a Bio-Center in Hyangnam for end-to-end CMO services and completed a bioplant in Hwaseong for microbial-based drug production. The company is FDA-registered with 5 FEI numbers and has 2 FDA-approved injectable products.

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.

HALIX

Netherlands

HALIX is a biologics CDMO based in Leiden, Netherlands, specializing in end-to-end development and GMP manufacturing of viral vectors, vaccines, and recombinant proteins. The company operates a 6,700 square meter cGMP facility at the Leiden Bio Science Park with 10 clean rooms and 7 bioreactors. HALIX successfully manufactured the AstraZeneca COVID-19 vaccine at commercial scale and serves over 75 customers with a 90% retention rate.

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.

Iasis Pharma S.A.

Greece

Iasis Pharma S.A. is a steadily growing Greek pharmaceutical company founded in Athens, engaged in the manufacture and marketing of a wide range of pharmaceutical products across multiple therapeutic areas. The company operates production facilities and offers products including oral solids, injectables, and topicals.

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.

Indian Immunologicals Ltd

India

Indian Immunologicals Ltd (IIL) is an Indian market leader in veterinary and human biologicals, manufacturing over 150 registered products. The company offers contract manufacturing services, producing safe and efficacious bio-pharmaceuticals for several leading pharma and vaccine companies in India and internationally. IIL exports animal and human vaccines to more than 50 countries and has sold billions of doses of vaccines.

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.

Intavis Peptide Services GmbH

Germany

Intavis Peptide Services GmbH is a Tubingen, Germany-based biotech company specializing in custom peptide synthesis for laboratory research and clinical trials. Founded in 2019 with over 30 years of peptide synthesis expertise, the company provides GMP-grade peptide production and aseptic fill and finish services, with a focus on neoantigen peptide cancer vaccines.

Intravacc

Netherlands

Intravacc is a Netherlands-based vaccine CDMO founded in 2013 with ~200 employees, specializing in vaccine development from discovery through Phase II clinical trials. The company provides cGMP manufacturing of bacterial, viral, conjugate, and oncological vaccines using mammalian and microbial fermentation systems (up to 200L single-use bioreactors), along with comprehensive analytical services and proprietary vaccine platforms including Outer Membrane Vesicle (OMV) technology.

Isotopia Molecular Imaging Ltd

Germany

Isotopia Molecular Imaging Ltd is a global leader in radiopharmaceuticals, developing, producing, and distributing diagnostic and therapeutic isotopes including Gallium-68, Terbium-161, and Lutetium-177 products. The company offers CMO services for sterile drug manufacturing through its aseptic plant and is FDA-registered with manufacturing operations in Israel and Germany.

JAMP Pharma

Canada

JAMP Pharma Group is a leading Canadian pharmaceutical company with over 35 years in the industry, active across generic drugs (JAMP Pharma), biosimilars (BioJAMP), branded products (Orimed Pharma), natural health products (Wampole/Laboratoire Suisse), and beauty products (Cosmetic Import). The company acquired a pharmaceutical manufacturing facility in Levis, Quebec, and manufactures prescription drugs in Canada through its JAMP Pharma Manufacturing division.