Drug Product CDMOs

PharmaResources (Kaiyuan) Co., Ltd.

China

PharmaResources (Kaiyuan) Co., Ltd. is a CRO/CDMO subsidiary of PharmaResources (Shanghai) Co., Ltd., based in Kaiyuan City, Liaoning Province, China. The Kaiyuan facility is a GMP-certified manufacturer specializing in medicinal chemistry and DMPK services. The company offers CDMO services including API manufacturing, with specific products listed on CPHI Online including Ticagrelor, Huperzine-A intermediates, and Peramivir trihydrate. Note: the pharmaresources.com domain now redirects to a weight loss supplement website unrelated to this company; the actual company operates via PharmaResources Shanghai's website.

Pharmatory Ltd

Finland

Pharmatory Ltd is a private Finnish CDMO specializing in small molecule synthesis, API process R&D, and cGMP contract manufacturing of active pharmaceutical ingredients. Founded in 2001 in Oulu, Finland, the company serves both NCE development projects and commercial products. Pharmatory has a worldwide customer base of pharma companies in both human and veterinary health. The company recently received investment from MB Funds to support growth. With 11-50 employees, Pharmatory is a compact, customer-oriented API specialist known for high dedication to customer success and quality. Recently celebrated its 25th anniversary.

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.

PMC Isochem (Isochem SAS, PMC Group)

France

PMC Isochem (Isochem SAS, part of PMC Group) is a French custom development and manufacturing organization specializing in active pharmaceutical ingredients and fine chemicals. Acquired by PMC Group International. Operates FDA-registered facilities with multiple FEI numbers. Provides R&D and custom manufacturing services for pharmaceutical and cosmetic peptides. Has a technology collaboration agreement with Polypeptide Therapeutic Solutions in the field of cosmetic and therapeutic polypeptides.

Polpharma API

Poland

Polpharma API is a European producer of Active Pharmaceutical Ingredients since 1951 and a CDMO provider, part of Polpharma Group. Headquartered in Poland with over 70 years of experience in process development, scale-up, and cGMP manufacturing. Advancing high potent API capabilities with OEL as low as 10 ng/m3 (OEB 5-6). Expanding into oligonucleotide production with GMP-compliant manufacturing up to 50g batch sizes. Offers cryogenic chemistry capabilities down to -90C. Operates kilo-lab, pilot, and commercial scale with Hastelloy and glass-lined reactors.

Prime Health Ltd. is a contract manufacturer for natural health products, nutritional supplements, and pharmaceutical products. Based in Maple Ridge, British Columbia, Canada (not UK as listed), they have a modern facility with advanced equipment. Job postings mention production workers for tablet coating, quality control technicians, R&D technicians, encapsulation roles, and formulation technicians. FDA-registered with FEI 3021784212 with 1 FDA inspection (VAI in 2022). Also listed on PharmaSource as a contract manufacturer and appearing at CPHI Frankfurt. The UK-based Prime Health referenced by Apposite Capital appears to be a different entity (www.prime-health.co.uk).

Raybow PharmaScience

China

Raybow PharmaScience (Raybow USA), a subsidiary of Jiuzhou Pharma, is a chemical CDMO specializing in custom synthesis, process development, analytical services, and cGMP production for small molecule APIs, specialty chemicals, and polymers. They offer services from benchtop R&D to commercial-scale production with facilities in North America, Europe, and Asia. FDA-registered for API manufacture and analysis.

Regis Custom Pharma (Regis Technologies, Inc.)

United States

Regis Technologies (now part of ESTEVE CDMO/Esteve Quimica) is a US-based API CDMO specializing in small molecule custom API synthesis, process development, analytical development, and cGMP manufacturing. They combine expertise in organic synthesis with chromatography separations (including chiral separations) to provide customized solutions from discovery to commercial delivery. They also manufacture chromatography products. FDA-registered for API manufacture with clean inspection history.

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.

Rontis

Greece

Rontis Corporation is a healthcare company headquartered in Zug, Switzerland with manufacturing operations including a pharmaceutical manufacturing facility in Larissa, Greece (FDA-registered, FEI 3002957541) and contract manufacturing operations in Veles, North Macedonia. The company is primarily known as a medical device and pharmaceutical manufacturer, with contract manufacturing as a secondary activity. Rontis supplies generics and operates in global markets with approximately $144.7 million in revenue.

Sanner GmbH

China

Sanner GmbH is a CDMO specializing in medical device development and pharmaceutical/nutraceutical packaging. The company offers full-service solutions from concept and engineering to pilot and large-scale production, with particular expertise in injection molding and desiccant integration for pharma-ready solutions.

Scale Up Laboratory s.r.o.

Czechia

Scale Up Laboratory s.r.o. is a small, privately owned CDMO based in the Czech Republic, operating since 2019. The company provides contract development and manufacturing of APIs and advanced intermediates, including clenbuterol hydrochloride, fluorinated pyrrolidines, and other specialty small molecules. The production facility is located in the Krkonose Mountains area at Mostek.

Seda Pharma Development Services Ltd

United Kingdom

Seda Pharma Development Services Ltd is a UK-based pharmaceutical development consultancy and clinical manufacturing services provider. Through its subsidiary Seda Clinical Manufacturing Services (MHRA-licensed), the company provides formulation development, clinical pharmacology, DMPK, modelling, and GMP manufacturing of clinical trial materials. The company focuses on product design, performance prediction, and clinical supply.

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.

Softigel (by Procaps Group)

Brazil

Softigel, a subsidiary of Procaps Group, is a CDMO headquartered in Brazil specializing in the development and manufacturing of soft gelatin capsules (softgels). With over 4 decades of experience, 7 manufacturing plants across the Americas, and 8+ patented softgel technologies, the company has developed 500+ products and has presence in 50+ countries.

DUPLICATE ENTRY: This is the same company as Sri Krishna Pharmaceuticals Ltd (companyId: 12028a28). SKPL was established in 1974 and specializes in bulk manufacture of APIs, DC granules, and finished dosage forms. See primary entry for full profile.

DUPLICATE ENTRY: This is the same company as Sri Krishna Pharmaceuticals Ltd (companyId: 12028a28). SKPL was established in 1974 and specializes in bulk manufacture of APIs, DC granules, and finished dosage forms. See primary entry for full profile.

DUPLICATE ENTRY: This is the same company as Standard Chem. & Pharm. Co. Ltd (companyId: 6a650983). See primary entry for full profile. Standard Chem. & Pharm. Co., Ltd. (SCP) is a Taiwanese CDMO established in 1967.

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.

Stason Pharmaceuticals, Inc. is a US-based pharmaceutical company headquartered in Irvine, California, with CDMO services provided through its affiliate Western PharmSci. The company operates in both branded/generic pharmaceuticals and contract services. Their CDMO capabilities include turn-key drug development and manufacturing for oral solid dosage forms with particular expertise in high containment products (OEL down to 0.1 ug/m3) for oncology, CNS, and other potent compounds. Services span from pre-formulation characterization and API synthesis through commercial production (up to 600 kg), including analytical method development/validation, formulation development, clinical trial materials, and serialization. They hold 30+ ANDAs and have operations in 13 locations across 9 countries. Note: FDA issued a warning letter on July 8, 2020, citing significant CGMP violations for finished pharmaceuticals.

Sterling Italy (Sterling S.p.A.) is a long-established Italian manufacturer specializing in the development, optimization, and manufacturing of steroidal APIs including corticosteroids, hormones, anabolics, estrogens, and progestinics. The company operates GMP production plants in Perugia, Italy and exports APIs to over five continents.

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.

Swiss American CDMO is a contract development and manufacturing organization headquartered in Carrollton, Texas, specializing in topical skin care, sun care, and wound care products. The company operates a 134,200 sq. ft. cGMP facility and a second 131,070 sq. ft. facility in the Dallas Metroplex. With over 35 years of experience, they develop, manufacture, package, and commercialize topical drug, skincare, wound care, and medical device formulations.

Synthesia a.s.

Czechia

Synthesia a.s. is a major Czech chemical manufacturer with over 100 years of history, headquartered in Pardubice. The Organics division produces pharmaceutical intermediates and APIs including Vitamin D derivatives. Key chemical technologies include nitration, hydrogenation, and phosgenation. FDA-registered with FEI number, with 5 FDA inspections (all VAI). The company supplies APIs and intermediates to the global pharmaceutical industry but positions itself primarily as a chemical/API manufacturer rather than a full-service CDMO.

Taiwanese CDMO specializing in transdermal drug delivery systems (TDDS), topical patches, and oral films. Over 30 years of experience in hydrogel patch, NSAID patch, and cosmetic patch development and manufacturing. Covers over 70% of OTC patches on the Taiwan market and exports to Asia, Europe, and North America. Also offers CMO and CRO services for transdermal patch development.

US-based topical and transdermal pharmaceutical CDMO, now merged with MedPharm (Durham, NC). Provides end-to-end services from formulation development through commercial manufacturing for topical, transmucosal, and transdermal drug products. Specializes in semi-solids, aerosols, liquids, injections, and transdermal patches. Offers in-vitro permeation testing (IVPT), in-vitro release testing (IVRT), disease activity models, tissue protein binding, and continuous flow technologies. GMP-certified manufacturing for generics, OTC, and prescription products.

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.

Chinese pharmaceutical manufacturer specializing in corticosteroid, hormone, and steroid API production. Subsidiary of Shanghai Pharmaceuticals (Shanghai Xinyi Pharmaceutical Factory). Founded in 1992, located in Tianjin with approximately 170,000 sq meters across two factory areas and 507 employees. Main products include hydrocortisone, spironolactone, hydrocortisone acetate, clobetasol propionate, and related corticosteroid APIs. Also produces tablet formulations (9 approved products). Has 11 API production licenses and 9 tablet production licenses. FDA-registered with 3 FEI numbers, 13 inspections (4 NAI, 8 VAI, 1 OAI), and 2 FDA-approved finished dosage form products.

TopChem Pharmaceuticals

Ireland

TopChem Pharmaceuticals Limited is an Irish GMP manufacturer of niche, low-volume active pharmaceutical ingredients (APIs), excipients, and other cGMP materials for the global generic and specialty pharmaceutical sector. Established in 2006, the company targets difficult-to-source products where volumes are low or special high grades are required. TopChem holds EU cGMP certification and has been FDA-inspected, operating from sites in Ballymote and Collooney, County Sligo, Ireland.

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.

Velesco Pharma (Pace Life Sciences)

United States

Velesco Pharmaceutical Services, now part of Pace Life Sciences (acquired by Pace Analytical), is a U.S.-based pharmaceutical CDMO specializing in drug development services. Per search results and industry listings, they provide analytical drug development, drug formulation, and pharmaceutical CDMO services. The acquisition by Pace Life Sciences expanded their capabilities in drug development services. The website (velescopharma.com) was blocked by Cloudflare security at scrape time, so detailed capability information is limited. They are listed on PharmaSource and CMOCRO as a CDMO.

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.

Wanbang Biopharmaceuticals is a Chinese pharmaceutical manufacturer based in Xuzhou, Jiangsu province, specializing in the development, manufacture, and sale of pharmaceutical products. The company has FDA registration and produces products including capsules and APIs such as Febuxostat and Apixaban.

Yuhan CDMO (Yuhan Chemical)

South Korea

Yuhan Chemical Inc. is a South Korean company and the API CDMO arm of Yuhan Corporation, focused on custom development and manufacturing of active pharmaceutical ingredients, intermediates, and regulated starting materials. Founded in 1980, it operates the largest API production capacity in Korea (~500,000L reactor volume) across Ansan and Hwaseong plants.

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.

Zhejiang Hisoar Pharmaceutical Co., Ltd. (stock code 002099, Shenzhen Exchange), founded in 1966 and headquartered in Taizhou, Zhejiang, China, is a diversified pharmaceutical and chemical company with ~3,000 employees and 426 R&D personnel. Their pharmaceutical division produces specialty APIs, intermediates, formulations, and fine chemicals -- specifically antibiotics (penem/carbapenem series, clindamycin series), cardiovascular agents, and anti-diabetic APIs. Over 70% of products are exported. They also have a major dye/pigment business segment (~70% global market share in Reactive Blue KN-R). The company has 3 FDA-registered FEI numbers for API manufacture, 7 FDA inspections (4 NAI, 3 VAI, 0 OAI), 2 FDA-approved products (capsule, tablet), 40+ invention patents, and partnerships with Boehringer Ingelheim, Merck, Sanofi, Novartis, GSK, and others. Classified as API manufacturer because the core pharma business is own-brand API and intermediate production with limited CDMO positioning, though PharmaSource lists them under CMO/CDMO.

2bind GmbH

Germany

2bind GmbH is a biophysics CRO based in Regensburg, Germany, specializing in biophysical analytical services for drug discovery. They support pharmaceutical and biotech clients with fragment-based drug discovery, covalent drug discovery, PROTAC characterization, antibody lead selection, and biologics characterization using technologies like GCI, MST, nanoDSF, DLS, ITC, and SEC-MALS.

360biolabs (a BioAgilytix company)

Australia

360biolabs, a BioAgilytix company, is Australia's most comprehensive bioanalytical laboratory offering pharmacokinetic, pharmacodynamic, immunogenicity, biomarker, and vaccine/infectious disease assay services. They support early-phase clinical studies with GLP-compliant testing across 6 global locations.

Acebright Group (Shanghai Acebright Pharmaceuticals) is a Chinese pharmaceutical company providing CDMO services through NMPA, FDA, EMA, and WHO-approved sites. They specialize in API manufacturing with over 20 years of technology development, and have a joint venture with Cipla for respiratory products in China.

Amarex Clinical Research, LLC

United States

Amarex Clinical Research, LLC is a full-service global Contract Research Organization (CRO) co-founded in 1998 and acquired by NSF International. The company provides clinical trial management, regulatory affairs, biostatistics, data management, pharmacovigilance, and medical writing services across all phases of drug development.

Anacura

Belgium

Anacura is a Belgian group of analytical service companies with 25+ years of experience in end-to-end analytical and laboratory services. The group includes AnaBioTec and Labo Nuytinck, plus OHMX.bio for multi-omics. Anacura provides analytical testing, quality control, and laboratory services for pharmaceutical and life science clients with FDA-registered operations.

Aurisco Pharmaceutical Co., Ltd. is a CRDMO (contract research, development and manufacturing organization) headquartered in Taizhou, Zhejiang, China, specializing in generic and complex APIs and finished dosage forms. The company focuses on small-molecule drugs, peptide therapeutics, and oligonucleotide pharmaceuticals. Aurisco operates 4 manufacturing sites and 5 R&D centers in China with 1,500+ staff, has passed 5 cGMP inspections in 2023 (USFDA, EUGMP, PMDA, NMPA, KFDA), and is expanding peptide manufacturing capacity. Their steroid product portfolio includes abiraterone acetate and complex hormone formulations.

AZIDUS LABORATORIES LIMITED

India

Azidus Laboratories Limited is a full-service clinical research organization (CRO) based in Chennai, India, supporting the pharmaceutical and biotechnology industries. Their services include bioavailability/bioequivalence (BA/BE) studies, Phase I-IV clinical trials management, regulatory submissions (CTD preparation), bioanalytical services (LC-MS/MS), clinical data management, statistical analysis, pharmacovigilance, and medical writing. They maintain a volunteer pool of over 45,000 participants. Azidus adheres to GCP, GLP, and international regulatory standards across therapeutic areas including oncology, cardiology, nephrology, urology, and diabetology. They are a CRO, not a drug manufacturer.

Berko Pharmaceuticals is a Turkish pharmaceutical company involved in the development, manufacturing, and marketing of pharmaceutical products including solid dosage forms and suppositories. Listed on CPHI as a CDMO specializing in development and manufacturing, with FDA-registered facilities and a long track record of FDA-inspected production (2 NAI inspections). Also has 27 FDA recalls on record, indicating substantial US market supply history.

BioIVT

United States

BioIVT is a global provider of biological research products and services, specializing in biospecimen solutions, ADME-Tox in vitro models, control matrices, and diagnostic solutions for drug and diagnostic development. They have opened a GMP-compliant facility for cell and gene therapy R&D materials but are primarily a biospecimen/research services company, not a drug manufacturer.

Bioneer A/S

Denmark

Bioneer A/S is a Danish not-for-profit Contract Research Organisation and subsidiary of the Technical University of Denmark (DTU). They specialize in in vitro modeling, drug formulation, and recombinant protein R&D services and manufacturing. While they offer CDMO services for recombinant protein production, their primary identity is as a CRO providing customized research services. Based in Horsholm, Denmark.