Sterile Injectable CDMOs

Bushu Pharma is Japan's premier CDMO with over 25 years of experience, specializing in contract manufacturing of solid dosage formulations, sterile injectables, lyophilized products, and prefilled syringes for both clinical trial supplies and commercial products. The company operates five factories in Japan with GMP certifications from 56 countries including FDA, EMA, and PMDA, serving over 90 pharmaceutical companies globally with nearly 50% of sales from foreign-affiliated clients.

Caplin Point Laboratories is a fully integrated Indian pharmaceutical company with a dominant presence in Latin America and Francophone Africa, and a growing presence in the US and EU. Through its subsidiary Caplin Steriles, the company manufactures sterile injectables, ophthalmic products, pre-mix bags, and pre-filled syringes, with 46 FDA-approved products.

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.

CordenPharma is a full-service CDMO providing integrated development and manufacturing of APIs, drug products, and lipid excipients across a global network of cGMP facilities in Europe and North America. The company offers capabilities spanning peptides, oligonucleotides, highly potent and oncology compounds, small molecules, injectables, lipid nanoparticles (LNPs), and oral solid dosage forms. CordenPharma is investing over EUR 500M in a new peptide manufacturing facility in Muttenz, Switzerland, and expanding its Colorado site for large-scale peptide production.

Hubei Enoray Biopharmaceutical Co., Ltd. is a Chinese high-tech biopharmaceutical company specializing in R&D, production, sales, and export of heparin, graded low molecular weight heparin APIs, and new antithrombotic drugs. The company holds EU GMP, Russian GMP, and US FDA approvals for its heparin and enoxaparin sodium production.

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.

International Drug Development Institute(IDDI)

Belgium

IDDI (International Drug Development Institute) is a clinical data science CRO specializing in biostatistics, clinical data management, strategic consulting, and eClinical technologies. Founded in 1991, the company has completed over 1,500 clinical trials for 350+ clients, with 80% repeat business. IDDI's therapeutic focus is oncology and ophthalmology, representing 75% of their work.

JEWIM Pharmaceutical (Shandong) Co., Ltd. is a Chinese pharmaceutical company in transformation, focusing on innovative drugs and complex drug delivery systems including inhalation products, nasal sprays, and long-acting injectable microspheres. The company is an established CDMO/CMO partner for multinational pharma companies including Johnson & Johnson (Xian Janssen), Kenvue, and Bayer, with quality systems certified by US FDA and Australian TGA. Products are exported to over 80 countries.

Jubilant HollisterStier CMO

Canada

Jubilant HollisterStier CMO (subsidiary of Jubilant Pharma) specializes in sterile fill-finish, lyophilization, injectables, ophthalmics, otics, topicals, and liquids for pharmaceutical and biopharmaceutical clients. End-to-end services from process development to inspection and packaging. Facilities in Spokane, WA and Montreal, QC. Won AWB Manufacturer of the Year 2024 and Manufacturing Excellence Award 2025. Largest manufacturer by employees in Spokane area. 92% repeat customer rate. FDA registered with 4 FEI numbers, 28 inspections (6 NAI, 18 VAI, 4 OAI -- elevated regulatory risk).

Lupin Limited (Lupin Manufacturing Solutions)

Brazil

Lupin Manufacturing Solutions (LMS) is the CDMO arm of Lupin Limited, one of India's largest pharmaceutical companies. LMS offers integrated CDMO services spanning API manufacturing, formulation development, and finished dosage form production. They operate 16 FDA-registered facilities with 512 FDA-approved products. They have recently expanded into oncology with a dedicated block at Vizag, India, and formed a strategic alliance with PolyPeptide for peptide supply chain scaling. Their extensive regulatory track record includes FDA, WHO, and multiple international approvals.

Oakwood Laboratories LLC is a US-based specialty pharmaceutical company and CDMO focused on advanced injectable drug delivery systems, particularly sustained-release and microsphere formulations. The company operates a GMP aseptic manufacturing facility in Solon, Ohio, providing contract development and manufacturing for long-acting injectable products.

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.

Pace Life Sciences is a division of Pace Analytical Services LLC, operating as a full-service CDMO/CRO network across the United States. The company supports drug development across the entire lifecycle from preclinical research through commercialization, specializing in small molecules, biologics (proteins, peptides, monoclonal antibodies, ADCs), nucleic acids (oligonucleotides, mRNA, plasmid DNA), and gene therapies. Recognized by PharmaSource as a Top CDMO in the United States. Operates 9+ strategically located sites including a sterile fill-finish Center of Excellence in Salem, NH.

PharmIdea is a Latvian CDMO located in Olaine, Latvia, specializing in sterile drug development, commercial production, and worldwide supply of pharmaceutical products. The company focuses on sterile drugs in vials, offering contract manufacturing services including product development. PharmIdea has completed CTDs for out-licensing and provides contract manufacturing of sterile injectables such as Levosimendan concentrate for solution for infusion (small batch), Caspofungin, and Carbetocin. The company has partnered with Lidds for manufacturing NZ-TLR9 formulation against solid tumors.

Piramal Pharma Solutions (PPS) is a global CDMO under Piramal Pharma Limited, offering end-to-end development and manufacturing solutions across the drug lifecycle. Operates through a globally integrated network of 17 development and manufacturing facilities across North America, Europe, and Asia, with distribution in 100+ countries. Services include drug discovery, process/pharmaceutical development, clinical trial supplies, and commercial supply of APIs and finished dosage forms. Specialized in highly potent APIs, antibody-drug conjugations, sterile fill/finish, and peptide products. Multiple CDMO Leadership Award winner.

Recordati is an Italian pharmaceutical company with both a proprietary product business (rare diseases, specialty/primary care) and a fine chemicals/CDMO division. Recordati Fine Chemicals (also known as Recordati Industria Chimica e Farmaceutica) provides contract API manufacturing. They have FDA-registered facilities, 26 approved products across multiple dosage forms, and significant industrial operations. The fine chemicals division offers API development and manufacturing services to third-party pharmaceutical companies.

Reliance Life Sciences (RLS), part of Reliance Industries, is a premier Indian biotechnology company providing contract manufacturing and development services across pharmaceuticals and biosimilars. They have FDA-registered manufacturing facilities with 7 FDA-approved products (injectables, powders, tablets). Their capabilities span API manufacturing, formulation development, biologics/biosimilar manufacturing, and cell and gene therapy R&D. They are a vertically integrated biotech company with 1,000-5,000 employees, offering CDMO services alongside their own product portfolio.

SEDICO Pharmaceutical Company is an Egypt-based pharmaceutical manufacturer and API producer, providing contract manufacturing (CMO/CDMO) services. The company manufactures a broad range of pharmaceutical products including oral solids, injectables, and various dosage forms. SEDICO has recently entered oncology drug production through a partnership with Sandoz Global to localize oncology pharmaceutical products in Egypt.

STA Pharmaceutical Co., Ltd. (WuXi STA) is a subsidiary of WuXi AppTec and one of the world's leading CDMOs, specializing in integrated CMC services for small molecule APIs and drug products (oral and injectable/sterile) from preclinical to commercial scale. They also have capabilities in oligonucleotides, peptides, and bioconjugates. WuXi STA operates 9-14 global manufacturing sites across Asia, North America, and Europe with uniform quality/EHS standards approved by major regulators. They have supported 50+ first-time drug approvals since 2017 across 105 countries. The company has 5,100+ scientists, claims 100% PPQ success rate, and serves 1,200+ customers. Their Changzhou site has passed US FDA inspection and they have a continuous manufacturing line for oral solid dose.

ST Pharm is a South Korean global API CDMO company founded in 1983, specializing in small molecule APIs, oligonucleotide therapeutics (ASO, siRNA, aptamers), and mRNA-LNP manufacturing. The company operates cGMP manufacturing facilities in South Korea and has a CRO subsidiary (AnaPath) in Switzerland and Spain for preclinical pathology services.

Sunny Pharmtech Inc. is a Taiwan-headquartered integrated specialty pharmaceutical CDMO specializing in high-potency APIs and drugs, including small molecules, peptides, and ADC linker-payloads. The company develops complex, high-barrier, niche drugs including ANDAs and 505(b)(2) filings, with state-of-the-art facilities offering OEB 5 containment and capabilities from early-stage formulation development to commercial manufacturing.

Symbiotec Pharmalab is a leading Indian manufacturer of corticosteroid and steroidal-hormone APIs with a global leadership position. With over 30 years of experience, the company has evolved from lab-scale manufacturing to industrial-scale production, operating two FDA-approved facilities (Rau and Pithampur, Indore). The company offers integrated CDMO solutions across organic chemistry, biotechnology/fermentation, and complex injectable platforms. It holds a 50%+ global market share in key steroid API molecules and serves 200+ customers in 40+ countries.

Division of Terumo Corporation (TSE:4543), a global healthcare technology leader since 1921 with 30,000+ employees. Provides sterile injectable contract development and manufacturing (CDMO) services from combination device design and formulation development to commercial manufacturing. Offers a portfolio of injection, infusion, and primary packaging solutions including PLAJEX polymer pre-fillable syringes, Immucise intradermal injection systems, hypodermic needles, and Surflo winged infusion sets. Recently expanded CDMO services outside Japan for global market and is doubling capacity.

TOT BIOPHARM is a China-based biopharmaceutical CDMO headquartered in Suzhou Industrial Park, providing end-to-end CDMO services with established technology platforms focused on biologics and ADC manufacturing. The company operates a large-scale GMP-compliant commercial production base with 20,000L monoclonal antibody drug substance capacity, and has achieved PMDA (Japan) accreditation. Listed on HKEX (1875.HK).

Unither Pharmaceuticals is a global CDMO specializing in sterile and non-sterile liquid pharmaceutical forms, and the world leader in Blow-Fill-Seal (BFS) technology with annual production capacity exceeding 5 billion doses. Founded in 1993 in France, they operate 9 production sites across Europe, North America, South America, and China with 2,500+ employees. They offer contract manufacturing (clinical and commercial), formulation/analytical development, out-licensing of turnkey products, co-development partnerships, and regulatory support including CTD/eCTD submissions. Products include BFS single-doses, multi-doses, vials, sprays, stick packs, and ophthalmic solutions.

Duplicate entry for VGXI Inc (see companyId 58cac364). Same company -- leading plasmid DNA CDMO in Texas. Same website URL (vgxii.com). Same capabilities, facilities, and services.

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.

Zambon is an Italian multinational healthcare group founded in 1906 with EUR 899 million in revenues and 2,768 employees. The group operates as both a pharmaceutical company (Zambon Pharma) and a CDMO, offering contract development and manufacturing services ranging from development through commercial production. Manufacturing plants in Vicenza (Italy), Cadempino (Switzerland), Haikou (China), and Barueri (Brazil) supply 87 countries. Also includes Zach System (API custom synthesis) as its chemical division.

Hainan Shuangcheng Pharmaceuticals Co., Ltd. (HNSP) is a publicly-traded Chinese pharmaceutical company founded in 2000, engaged in R&D, manufacturing, and sales of pharmaceutical products with a focus on peptide APIs and injectable formulations. The company offers CDMO/contract manufacturing services representing 20-35% of revenue, and has FDA-registered facilities with multiple FDA inspection history. It operates manufacturing sites in Haikou and has invested in a Ningbo facility.

Hainan Zhonghe Pharmaceutical Co., Ltd., a subsidiary of Hainan Zhonghe (Group) Co., Ltd., is described as a leading high-tech pharmaceutical enterprise in Asia. The company manufactures pharmaceutical products including APIs and finished dosage forms such as Eptifibatide Injection, Entecavir Dispersible Tablets and Capsules, and Octreotide. It sells APIs and formulations through CPHI and other channels.

PiSA (Grupo PiSA / PiSA Farmaceutica) is a major Mexican pharmaceutical company manufacturing 1,500+ branded medications across 17 specialty lines in 14 production plants strategically located in Mexico. Employs approximately 30,000 workers. PiSA USA serves as the nearshore contract manufacturing arm, offering pharmaceutical and medical device CMO services. Company is a Socially Responsible Enterprise (ESR) for 15 consecutive years. Offers 'Maquila de Productos' (contract manufacturing) as a core service.

Lisapharma S.p.A. is an Italian pharmaceutical company specializing in the contract manufacturing of sterile injectable products, located in Erba (Como), Italy. The company provides sterile fill/finish services for vials, syringes, and cartridges, with capabilities in lyophilization. The website domain lisapharma.com is no longer active, but the company operates from lisapharma.it and is FDA-registered for manufacturing.

Lundbeck Pharmaceuticals Italy SpA

Italy

Lundbeck Pharmaceuticals Italy SpA is an Italian API manufacturer with 80 years of industry experience, producing Active Pharmaceutical Ingredients including Metoclopramide Hydrochloride. Part of the Lundbeck Group (Denmark), they operate multiple FDA-registered facilities with extensive inspection history. While primarily a proprietary pharma manufacturer (Lundbeck is known for CNS drugs), their Italian operation manufactures APIs and has FDA-approved products across injectable and oral dosage forms. They also have clinical trial activity in CNS/Neurology and Immunology.

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.

NovaCina is a sterile injectable CDMO based in Perth, Western Australia, launched by Bridgewest Group. The company manufactures sterile injectable drug products for all phases from development through commercial production. NovaCina has expanded its facility with a high-tech SA25 GMP filling line for small-batch sizes and has since merged with BioCina to create an end-to-end CDMO offering integrated biopharmaceutical and small molecule contract manufacturing services.

OLIC (Thailand) Limited is one of the largest toll and contract manufacturers in Southeast Asia for branded pharmaceutical and healthcare products. The company is a subsidiary of Fuji Pharma and serves over 30 multinational companies including most Big Pharma organizations. OLIC's PIC/S-compliant manufacturing facility produces a wide range of dosage forms including sterile liquids, oral solids, semi-solids, and liquids, serving markets in Thailand, Southeast Asia, Japan, Australia, the US, and Europe.

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.

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.

Pii (Pharmaceutics International, Inc.), acquired by Jabil in February 2025, is a US-based CDMO specializing in complex formulations. With over 30 years of experience and 300+ scientists and support staff, Pii handles potent compounds, complex formulations, aseptic injectables, complex oral dosage forms, and high-potency soft gels. Offers phase-appropriate support from early development through commercial manufacturing. Located in Hunt Valley, Maryland. 100% FDA licensed with 5 drug product approvals in 2023.

PSM GmbH is a German pharmaceutical CDMO specializing in aseptic fill and finish services for drugs, biologics, and biopharmaceutical products. The company offers end-to-end commercial fill and finish services with state-of-the-art flexfill filling-line technology and formulation development capabilities. Limited website data is available, but search results consistently identify PSM as a specialized aseptic fill/finish CDMO.

Shree Venkatesh International Limited (SVIL) is an Indian manufacturer and exporter of male and female human hormonal products, including both APIs and finished dosage forms. The company offers contract manufacturing services for pharmaceutical drug products and APIs, with a focus on hormonal therapies. SVIL markets its products internationally through branded and generic channels.

Sovereign Pharmaceuticals, LLC is a U.S.-based CDMO located in Fort Worth, Texas, specializing in small-batch prescription drugs. The company packages both solid and liquid pharmaceutical products and has a high potency pharma suite. Sovereign has over 30 years of expertise and was acquired through bankruptcy proceedings by Alora Pharmaceuticals.

Synergy Innovation Inc. is a US-based company that leverages technology to transform manufacturing processes, providing high-speed assembly lines and non-destructive inspection systems. No website is available and search results do not indicate pharmaceutical drug manufacturing. The company appears to be an equipment/technology supplier rather than a CDMO.

Corning Incorporated (Life Sciences & Pharmaceutical Technologies)

India

Corning Incorporated's Pharmaceutical Technologies division manufactures advanced glass packaging solutions for the pharmaceutical industry, most notably Valor Glass vials and containers designed for drug storage and delivery. The company is a materials science and glass technology company, not a drug manufacturer or CDMO.

CSL (incl. CSL Behring)

Australia

CSL is a global biotechnology company headquartered in Melbourne, Australia, operating through CSL Behring, CSL Seqirus, and CSL Vifor. The company specializes in plasma-derived biotherapies for rare and serious diseases including bleeding disorders and immunodeficiencies, vaccines, and iron deficiency treatments, but operates as an integrated developer/manufacturer for its own products rather than as a CDMO offering contract services to external clients.

EMA Pharmaceuticals (Ema Pharma)

France

EMA Pharmaceuticals (Ema Pharma) is a French manufacturer of overseals (crimping capsules) for injectable pharmaceutical applications. The company specializes in sealing solutions for vials used in pharmaceutical injectable products, manufactured in a GMP-compliant facility. Note: The FDA regulatory data (90 approved products, 184 recalls) appears to be associated with a different entity sharing the FEI registrations, not the French crimp cap manufacturer.

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.

Solventum

China

Solventum (spun off from 3M) is a healthcare company whose Purification and Filtration business provided biopharmaceutical purification solutions including chromatography media, filtration membranes, and purification systems. This business unit has been acquired by Thermo Fisher Scientific. Solventum supplied equipment and consumables for bioprocessing, not contract drug manufacturing.