Sterile Injectable CDMOs

PHT International is a full-service Contract Research, Development, and Manufacturing Organization (CRDMO) headquartered in China, providing innovative solutions to leading life science companies. Offers global solutions in contract research and manufacturing to partners within the pharmaceutical, agrochemical, and specialty chemical industries. Includes import/export services and sterile CDMO manufacturing capabilities.

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.

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.

Axcellerate Pharma LLC

United States

Axcellerate Pharma LLC is an award-winning CDMO based in Piscataway, New Jersey, providing CRO and CDMO services for both large and small molecules. Their capabilities span cGMP API manufacturing (small molecules), sterile aseptic filling (vials, syringes, cartridges, bags), lyophilization, mammalian cell culture, microbial fermentation, oligonucleotide synthesis, PEGylation, and commercial manufacturing including generics, controlled substances, hormones/steroids, and cytotoxic/oncology compounds. The company operates from a multi-faceted facility that includes ISO Class 5-8 sterile areas, dedicated process areas for biologics development, chemical development, and sterile manufacturing.

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.

BioTechnique LLC

United States

BioTechnique LLC is a full-service CRDMO based in York County, Pennsylvania, specializing in cytotoxic and therapeutic sterile injectable fill-finish services. The company provides services from investigational/clinical through to final marketed products, handling both small and large batch sizes. BioTechnique operates an FDA-registered facility with capabilities spanning sterile manufacturing, lyophilization, and high-potency compound handling.

Polpharma / Polpharma API

Kazakhstan

Polpharma is the leader of the Polish pharmaceutical market and one of the leading drug manufacturers in Central and Eastern Europe, with origins dating to 1935. Produces 400 million packages annually across 5 manufacturing plants and 3 R&D centers. The group includes Polpharma API (CDMO/API manufacturing), Polpharma Biologics (state-of-the-art biologic manufacturing including biosimilars and innovative molecules), and Farmaprojects (B2B hub). Has received grants for RNA-based medicines development under the STEP initiative. FDA registered for API manufacture.

Shandong Lukang Pharmaceutical Co. Ltd.

China

Shandong Lukang Pharmaceutical Co., Ltd. is a leading Chinese bio-pharmaceutical enterprise founded in 1966 in Jining, Shandong, listed on the Shanghai Stock Exchange (600789) since 1997. The company specializes in the supply of antibiotics and other pharmaceutical APIs, with 5 FDA-registered sites and EDQM certifications. FDA-approved products include an extended-release intramuscular suspension.

TAPI (Teva API)

Netherlands

TAPI (Teva Active Pharmaceutical Ingredients) is the API division of Teva Pharmaceutical Industries, positioned as the world's leading international supplier of APIs with 350+ products in their portfolio. They offer integrated API and CDMO services, leveraging 85+ years of API development and manufacturing expertise. TAPI provides customized solutions including complex API development, peptide manufacturing (including GLP-1 capability), and end-to-end manufacturing. They have a partnership with Antheia for biosynthetic pharmaceutical ingredients and with Sagimet Biosciences for resmetirom API. TAPI operates globally with multiple manufacturing sites.

Recce Pharmaceuticals

Australia

Recce Pharmaceuticals (ASX:RCE) is a clinical-stage biotech company developing its own proprietary synthetic anti-infectives (RECCE 327, RECCE 529) for antibiotic-resistant bacterial and viral infections. They have an in-house pilot manufacturing facility in Macquarie Park, Sydney for their own compounds only -- they are NOT a contract manufacturer (CDMO/CMO). They conduct clinical trials (Phase I-III) for their own drug pipeline. The FDA registration data and approved products listed in the regulatory summary likely belong to a different entity sharing the FEI numbers, not this clinical-stage company.

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.

Macleods Pharmaceuticals Ltd

India

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

Biological E Limited

India

Biological E Limited is an Indian biopharmaceutical company focused on vaccine development and manufacturing, with production capacity of up to 1 billion vaccines annually. They offer contract manufacturing for vaccines and biologics, with FDA-registered facilities performing analysis, API manufacture, labeling, manufacturing, and packing. Partners include Bavarian Nordic for chikungunya vaccine manufacturing.

Akums Drugs & Pharmaceuticals Ltd

India

Akums Drugs & Pharmaceuticals Ltd. is India's largest CDMO with 30% domestic market share, operating 15+ state-of-the-art manufacturing facilities with over 4,100 commercialized formulations across 60+ dosage forms. The company serves 1,500+ pharmaceutical companies and provides end-to-end services including API manufacturing (737 MT annual capacity across 3 facilities), formulation development, clinical trial materials, and commercial-scale production of tablets, capsules, injectables, soft gels, syrups, topicals, and nutraceuticals.

Biomatrix Healthcare Pvt. Ltd.

India

BioMatrix Healthcare Pvt. Ltd. is an Indian pharmaceutical company established in 2007, headquartered in Ahmedabad, specializing in 100% export of pharmaceutical products to 40+ countries. Their manufacturing facility is WHO-GMP, EU-GMP certified and compliant with US-FDA, UK-MHRA, and ANVISA standards, with Health Canada site approval. Capacity: 5 billion tablets, 1 billion capsules, 24 million liquids, and 18 million dry syrups per annum. 1,000+ product registrations. Expanding with a new API manufacturing facility in Vadodara.

Lyomark Pharma GmbH

Germany

Lyomark Pharma GmbH is a German CDMO specializing in sterile medicinal products. They organize contract manufacturing based on dossiers they compile and maintain, and offer regulatory services. Through their subsidiary Lyocontract, they operate a state-of-the-art pharmaceutical manufacturing site. They have 39 FDA-approved products across injectable, oral solid, and liquid dosage forms. The company focuses on niche indications for the hospital market with global distribution.

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.

Avid Bioservices, Inc.

United States

Avid Bioservices, Inc. is a dedicated biologics CDMO based in Costa Mesa, California, with 30+ years of experience in mammalian cell culture-based biologics manufacturing. The company provides end-to-end drug substance and drug product services for monoclonal antibodies, bispecific antibodies, enzymes, and recombinant proteins. Avid operates from its main facility plus a new 78,000 sq ft Early Phase Center of Excellence (opened February 2026) for early-stage development. Services include cell line development, process development, analytical method development, cGMP manufacturing, and late-stage clinical and commercial biologics production. Avid has built a track record as one of the few US-based pure-play biologics CDMOs.

Biophore India Pharmaceuticals

India

Biophore India Pharmaceuticals Pvt. Ltd. is a Hyderabad-based research-driven pharmaceutical company specializing in the development and manufacturing of niche active pharmaceutical ingredients (APIs) for global markets. Focus areas include oncology, contrast agents, peptides, injectable APIs, and orphan drugs. They have 110+ US DMFs, 150 global DMFs, 20+ CEPs, and 4 US FDA and EU approved manufacturing facilities. FDA-registered with 5 approved products (capsules, tablets). Partner relationships include Oakrum Pharma.

Shenzhen Hybio Pharmaceutical Co., Ltd. (Hybio) is a Chinese pharmaceutical company founded in 1998, specializing in peptide drug R&D, manufacturing, and commercialization with a CRDMO division. The company focuses on peptide APIs (including semaglutide) and sterile injectable formulations, with products sold in 30+ countries. Hybio has 7 FDA-registered facilities and a strategic partnership with Dr. Reddy's for peptide API supply, and recently partnered with Huawei for AI-driven drug development.

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.

Waisman Biomanufacturing

United States

Waisman Biomanufacturing is an academic CDMO based at the Waisman Center at the University of Wisconsin-Madison, specializing in advancing novel biologics and vaccines into early clinical trials. The facility manufactures plasmid DNA, recombinant proteins, cell therapeutics, extracellular vesicle/secretome products, live biotherapeutic products, and viral vectors under cGMP conditions.

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.

Aggrega Pharma, LLC

France

Aggrega Pharma LLC is a U.S.-based pharmaceutical company created in 2019 by four European-based pharmaceutical companies (Bluepharma, Rafarm, Substipharm, Welding) focused on developing, manufacturing, and marketing generic drug products. The company leverages its shareholders' development and commercial manufacturing facilities, including FDA-inspected sites in Portugal and Greece, with capabilities in oral solids, sterile injectables, and complex ophthalmics.

Biofer S.p.A.

Italy

Biofer S.p.A. is an independent Italian pharmaceutical company specializing in the manufacture of Active Pharmaceutical Ingredients (APIs) for nearly 40 years. Core products include iron complexes (antianemics), heparin and glycosaminoglycans, steroids, enzymes, and folinates. The company operates under strict GMP standards with an emphasis on quality, safety, and efficacy. FDA-registered with 3 inspections (0 NAI, 3 VAI).

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.

Astrea Pharma

France

Astrea Pharma is a CDMO founded with the purpose of building a customer-focused manufacturing network covering development to commercial supply. They acquired the Fontaine-les-Dijon solid dose manufacturing site from Recipharm and offer oral solid dose and aseptic manufacturing capabilities from development through commercial supply, with a focus on efficiency and value in the pharma supply chain.

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.

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.

Adragos Pharma

Germany

Adragos Pharma is a globally operating CDMO headquartered in Munich, Germany, specializing in small molecule finished dosage forms. They operate six manufacturing sites across Europe and Japan: Athens (Greece, HPAPI capabilities), Halden (Norway, BFS sterile production), Jura (Switzerland, small-batch clinical/commercial), Kawagoe (Japan, ampoules and tablets), Livron (France, sterile liquids and suppositories), and Leipzig (Germany, semi-solid and non-sterile liquids).

NEXUS COMPANY INC

Japan

NEXUS COMPANY INC is a Kyoto, Japan-based manufacturer of quartz glass vials, test tubes, and screw-neck containers for pharmaceutical, laboratory, and analytical applications. The company produces the world's first mass-produced quartz vials (SiO2 99.99% fused quartz) with properties including non-alkali elution, high heat resistance, and UV transmittance. Note: This is distinct from Nexus Pharmaceuticals (US), which is a sterile injectable CDMO.

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.

Oncotec Pharma Produktion GmbH is a German CDMO specializing in the development and aseptic manufacturing of cytostatic (anticancer) drugs. Founded in 1997, the company provides full-service contract manufacturing from lab-scale development through commercial production, with approximately 2,300 m2 of cleanroom space and isolator-protected production lines at its Dessau-Rosslau facility.

Rentschler Biopharma

Germany

Rentschler Biopharma is a leading global CDMO focused exclusively on biopharmaceuticals, with over 50 years of industry experience. The company contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023, has supported 180+ biotherapeutics, and serves 180+ clients worldwide. It is an independent family-owned company employing approximately 1,400 people.

Akriti Pharmaceuticals Pvt. Ltd.

India

Akriti Pharmaceuticals Pvt. Ltd. is an Indian pharmaceutical manufacturer with EU GMP and TGA approved manufacturing facilities. The company delivers affordable quality medicines across the world with efficient manufacturing services backed by a qualified technical team, operating as a contract manufacturer for global healthcare partners.

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.

Pharmazeutische Fabrik Montavit GmbH

Austria

Pharmazeutische Fabrik Montavit GmbH is an Austrian family-owned pharmaceutical company founded in 1945 in Absam, Tyrol. The company researches, develops, and manufactures pharmaceutical products and medical devices, exporting to over 80 countries. Montavit offers contract manufacturing (Lohnherstellung/Auftragsfertigung) services to other pharmaceutical companies. Dosage forms include tablets, film-coated tablets, dragees, liquids, creams/gels, granulates, suppositories, sterile pre-filled syringes, laminate tubes, sterile blisters, and powders. The company's own product portfolio covers urology, gynecology, allergy, sleep, travel health, and herbal medicines, with the wound care product Acerbine being well-known.

Vibalogics is a specialized global CDMO for virotherapy manufacturing, now operating as Recipharm Advanced Bio after acquisition by Recipharm AB. The company offers process and analytical development, GMP manufacturing of viral vectors, oncolytic viruses, and advanced therapies. Capabilities include xRNA therapies, viral vectors (AAV, lentivirus), microbial/live biotherapeutic products, recombinant proteins, plasmid DNA, and lipid nanoparticles. Major $50M expansion of Cuxhaven facility (500L manufacturing line) completed. 118,000 sq ft GMP facility in Massachusetts (US) also completed.

ACIC Pharmaceuticals Inc

Canada

ACIC Pharmaceuticals Inc is a CDMO headquartered in Coral Springs, Florida, providing integrated pharmaceutical solutions from molecule to market. They offer API manufacturing, CDMO services for complex injectables including long-acting and cytotoxic injectables, regulatory support, and pharmaceutical equipment solutions. They have 249 FDA-approved products across a wide range of dosage forms.

Pharmaceutical Manufacturing Research Services (PMRS) is a U.S.-based cGMP contract manufacturer providing sterile CDMO manufacturing services. Located in Horsham, Pennsylvania, the company specializes in sterile injectable manufacturing and spray drying capabilities.

Cardinal Health Clinical Supply Services is a division of Cardinal Health providing contract manufacturing and pharmacy solutions for biopharmaceutical companies. The company offers clinical supply services, sterile injectable manufacturing, and radiopharmaceutical contract manufacturing, with 39 FDA-registered facilities and extensive commercial-scale production capabilities.

Prahem Laboratories LLP

India

Prahem Laboratories LLP is an Indian pharmaceutical company and sister company of Sneha Medicare Pvt Ltd (established 1985). Based in Mumbai, they operate as a CMO/CDMO with capabilities in development, production, and marketing of specialty medicines, generic medicines, OTC products, and new therapeutic development. Listed on CPHI Online as CMO/CDMO with distributor/import-export and generics/biosimilars manufacturing capabilities. Their business verticals include APIs, finished dosage forms (including oncology and contrast media), and export to LATAM, CIS, and Southeast Asian markets.

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.

API Co., Ltd. (Japan)

Japan

API Co., Ltd. is a Japanese pharmaceutical company specializing in contract manufacturing (CMO/CDMO) of antibiotics (vials, lyophilized products), APIs (including heparinoid), and biotech products. Their Ikeda Pharmaceutical Plant handles antibiotic formulation, lyophilization, powder filling, and packaging under GMP conditions.

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.

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.

Baxter International

China

Baxter International is a global medtech and biopharma company. Through its BioPharma Solutions (BPS) division, Baxter operates as a major CDMO providing sterile fill/finish manufacturing services. BPS invested over $150M in expanding sterile fill/finish capacity at its Bloomington, Indiana facility. Note: Baxter has signed a definitive agreement to divest its BioPharma Solutions business. Baxter has 308 FDA-approved products, extensive manufacturing facilities worldwide, and 93 FDA inspections on record.

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.