Analytical Services CDMOs

Helix Biotech, Inc.

United States

Helix Biotech, Inc. is a U.S.-based CDMO specializing in GMP formulation and RNA manufacturing, including DNA, RNA, and LNP (lipid nanoparticle) formulations. The company offers end-to-end services from RNA construct design through its StrandSolve platform to GMP manufacturing via its NOVA IJM nanoparticle formulation platform.

Help S.A. (HELP Pharmaceuticals)

Greece

HELP Pharmaceuticals is a Greek pharmaceutical company founded in 1971, operating an EU-GMP certified production facility in Ioannina, Greece. The company manufactures pharmaceuticals, medical devices, nutraceuticals, and cosmeceuticals across sterile and non-sterile lines, including solid, liquid, and semi-solid dosage forms. HELP serves partners in more than 50 countries and provides clinical manufacturing and packaging services.

Helvetic BioPharma SA

Switzerland

Helvetic BioPharma SA is a Swiss biopharmaceutical company based in Mezzovico, Ticino, specialized in the manufacturing of biological high-value products and active compounds. The company offers CMO bioprocessing services including mammalian cell culture and microbial fermentation. Its product portfolio includes recombinant proteins, hormones, and peptides, with PEGylation capabilities for long-acting molecules.

Heraeus Precious Metals GmbH & Co. KG

Germany

Heraeus Precious Metals GmbH & Co. KG is the pharmaceutical ingredients division of the Heraeus Group, specializing in the production of generic highly potent active pharmaceutical ingredients (HPAPIs) for cancer treatment. The company is the global market leader for platinum-based active ingredients including cisplatin, carboplatin, and oxaliplatin. In 2021, Heraeus made a multi-million euro investment expanding HPAPI manufacturing capacity in Hanau, Germany.

HERMES PHARMA

Austria

HERMES PHARMA is an Austrian CDMO and the leading expert in developing and manufacturing user-friendly oral dosage forms. A sister company of HERMES Arzneimittel (100+ years of pharmaceutical excellence), HERMES PHARMA offers a one-stop-shop from product design through GMP manufacturing. The company recently announced a 25 million euro investment to expand oral drug production capabilities. Their dosage form portfolio includes effervescent tablets, chewable tablets, orally disintegrating granules, instant drinks, and lozenges.

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.

Hongene Biotech

China

Hongene Biotech is a China-based CDMO specializing in oligonucleotide and mRNA manufacturing services. The company provides custom DNA/RNA synthesis and large-scale oligonucleotide production for pharmaceutical and biotech customers globally.

Hovid Bhd

Malaysia

Hovid Bhd is a Malaysia-based pharmaceutical company with over 80 years of history, operating as both a branded generic producer and contract manufacturer. The company offers a portfolio of over 400 products including generic drugs, OTC supplements, disinfectant solutions, medical devices, and consumer products, with distribution in more than 50 countries.

Hovione

China

Hovione is a specialist integrated CDMO dedicated to helping pharmaceutical customers bring new and off-patent drugs to market. Founded in 1959, the company provides API development and manufacturing, drug product development, and particle engineering services across four GMP manufacturing sites worldwide.

HTL Biotechnology

France

HTL Biotechnology is a French biotech company and world leader in the development and responsible biomanufacturing of pharmaceutical-grade biopolymers, primarily hyaluronic acid (sodium hyaluronate) and polynucleotides (PDRN/PN). The company produces these as raw materials/APIs for pharmaceutical, medical device, and cosmetic applications via fermentation technology.

Iberfar – Industria Farmaceutica, S.A.

Portugal

Iberfar, Industria Farmaceutica, S.A. is a privately owned Portuguese pharmaceutical contract manufacturer founded in 1924. The company specializes in contract manufacturing of solid forms and non-sterile liquid products, including controlled drugs, at its EU cGMP-certified facility near Lisbon.

Icosagen

Estonia

Icosagen is a private, science-driven biologics CRDMO headquartered in Estonia, combining CRO and CDMO capabilities under one roof. With 25 years of expertise, the company provides integrated services spanning antibody discovery, protein production, cell line development, ADC conjugation, process development, and GMP manufacturing for mammalian protein drug candidates.

ICROM S.p.A.

Italy

ICROM S.p.A. is an Italian custom API development and manufacturing company based in Concorezzo (MB), specializing in custom development, custom manufacturing, and APIs for specialty drugs. The company operates under cGMP with inspections by AIFA, USFDA, PMDA, and KFDA, and holds Drug Master Files in all major regulatory markets. ICROM recently acquired Holodiag and has a subsidiary Proxis.

INCOG Biopharma Services

United States

INCOG BioPharma Services is a US-based CDMO headquartered in Fishers, Indiana, providing end-to-end solutions for sterile injectable drug products from clinical through commercial phase. The company operates a purpose-built, FDA-approved and Annex 1-compliant facility with state-of-the-art fill/finish capabilities and is undergoing a $200 million expansion to boost production capacity.

Indena

France

Indena is an Italian company with over 100 years of botanical and pharmaceutical expertise, headquartered in Milan. It provides CDMO services specializing in complex API manufacturing including semisynthesis, fermentation, and high-containment processing for HPAPIs with OEL as low as 1 ng/m3. Indena is AIFA-approved and FDA-registered, with particular focus on oncology-related ADC components and complex chemical synthesis.

Integrated DNA Technologies (IDT)

Belgium

Integrated DNA Technologies (IDT), a Danaher company, is a global genomics leader with nearly 40 years of experience in oligonucleotide synthesis. IDT opened its first therapeutic oligonucleotide cGMP manufacturing facility in Coralville, Iowa in 2023, producing cell and gene therapy reagents, CRISPR guide RNAs, and therapeutic oligonucleotides under cGMP conditions. The company also provides custom GMP oligos, primers, and probes.

Ion Labs, Inc.

United States

Ion Labs, Inc. is a US-based contract manufacturer of dietary supplements and nutritional products, part of HBI Health & Beauty Innovations (now Ourvita Group). With 40+ years of experience, 300+ employees, and 300,000 sq ft facilities in Largo, Florida, Ion Labs manufactures capsules, gummy vitamins, liquid capsules, cap-in-cap, powders, and tablets. The company recently completed a $30 million gummy production expansion increasing capacity to 50 million gummies per month.

Kemwell Biopharma Private Limited

India

Kemwell Biopharma is one of India's largest biologics CDMOs, providing integrated drug substance and drug product development and manufacturing services from a single site in Bangalore. Established with technological support from a leading German biopharmaceutical company, Kemwell serves global pharma and biotech organizations with capabilities spanning monoclonal antibodies, complex fusion proteins, recombinant proteins, and bispecific antibodies. The company has received U.S. FDA approval for commercial drug product manufacturing and operates hybrid biomanufacturing with both stainless steel and single-use bioreactor systems.

Kincell Bio

United States

Kincell Bio is a specialized cell therapy CDMO based in the United States, dedicated exclusively to advancing autologous and allogeneic cell therapies from early clinical supply through pivotal and commercial launch. They provide process development, analytical development, and cGMP manufacturing services. The company operates manufacturing facilities in Research Triangle Park, North Carolina (32,800 sq ft acquired in 2024) and Gainesville, Florida. They have a strategic collaboration with Duke University School for cell and gene therapy innovation, and a partnership with RegCell to advance Treg cell therapies for autoimmune diseases.

Kindeva Drug Delivery

United Kingdom

Kindeva Drug Delivery is a leading global drug-device combination CDMO specializing in sterile injectables, pulmonary and nasal inhalation, and dermal/transdermal drug delivery platforms. The company has a history spanning back to 1956 when it invented the pressurized metered-dose inhaler (pMDI). Kindeva operates a global network of 10 manufacturing and R&D sites including a 155,000+ sq ft dedicated aseptic operations facility in Bridgeton. They hold 12 FDA-approved products across aerosol, metered-dose, film, and extended release dosage forms. Their FDA record shows 38 inspections (9 NAI, 22 VAI, 7 OAI) and 6 FEI-registered facilities covering analysis, manufacture, and sterilization.

KinOmega Biopharm Inc.

China

KinOmega Biopharm Inc. is a leading Chinese manufacturer of Omega-3 fish oil EPA/DHA, producing both pharmaceutical-grade (API) and nutraceutical-grade products. They hold 9 DMFs, 4 GMP approvals (US FDA, Korean FDA, Japan PMDA), and CEP/COS certification for pharmaceutical-grade purity. Their FDA-registered facility (FEI 3009754809) has been inspected with 0 observations. KinOmega uses proprietary 3-times molecular distillation purification with 11-stage SPD technology. They also operate a softgel production line (4 million capsules/day). This is an API and ingredient manufacturer, not a contract drug product CDMO. Their products meet Ph. Eur. and USP standards.

LABIANA

Spain

LABIANA is a Spanish pharmaceutical group founded in 1958 with over 60 years of history, now listed on BME Growth. They operate as a CDMO serving both human and veterinary pharmaceutical sectors. LABIANA has three EU-GMP manufacturing plants: Labiana Pharmaceuticals in Corbera de Llobregat (Barcelona) for human pharma with sterile liquids, non-sterile liquids, and non-sterile solids; and Labiana Life Sciences in Terrassa (Barcelona) plus Veterinarski Zavod Subotica in Serbia for veterinary products including biologicals (viral, bacterial, and autogenous vaccines). The company is a benchmark in contract manufacturing for sterile forms and also manufactures/distributes Fosfomycin Trometamol under its own brand. Their subsidiary Zoleant Pharmaceuticals handles global marketing of niche alternative brand medicines.

Landmark Bio

United States

Landmark Bio is a cell and gene therapy CDMO based in Watertown, MA, focused on the development and manufacturing of advanced therapies. Offers end-to-end services including process and analytical development, formulation development, cGMP manufacturing, fill/finish, quality control testing, CMC consulting, and IND-enabling services. Acquired by Artis BioSolutions (a new genetic medicines CDMO) to form a comprehensive advanced therapy manufacturing platform. Facility is a 44,000 sq ft full-spectrum manufacturing site.

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.

LGC Biosearch Technologies

United Kingdom

LGC Biosearch Technologies is a CDMO and part of the global LGC life sciences group, specializing in custom oligonucleotide synthesis and nucleic acid therapeutics manufacturing. The company manufactures siRNA, antisense oligos, and other nucleic acid-based therapeutic APIs under GMP conditions, alongside genomics reagents and instruments for research use.

Lifecore Biomedical

United States

Lifecore Biomedical (Nasdaq: LFCR) is a fully integrated CDMO headquartered in Chaska, Minnesota, specializing in sterile injectable drug product development and manufacturing. The company has over 40 years of experience in aseptic fill/finish, with particular expertise in highly viscous formulations. Lifecore is also a premium producer of non-animal-sourced sodium hyaluronate.

Linnea SA

Switzerland

Linnea SA is a Swiss pharmaceutical manufacturer with a 40-year legacy specializing in the production of active pharmaceutical ingredients of botanical origin. The company operates from a GMP-certified facility in Switzerland and is known for producing APIs such as scopolamine butylbromide, vinpocetine, vincamine, 5-HTP, and botanical extracts (ginkgo biloba, red clover, bilberry). Linnea complies with GACP guidelines for raw material sourcing.

List Biological Laboratories Inc

United States

List Biological Laboratories Inc (List Labs) is a US-based CDMO with over 45 years of experience specializing in microbial-derived biologics and live biotherapeutic products (LBPs). The company provides cGMP manufacturing services for bacterial fermentation, harvest, purification, lyophilization, and encapsulation of therapeutic and vaccine products including polysaccharides, toxins, toxoids, and recombinant proteins. List Labs also manufactures nearly 100 research reagents.

Losan Pharma GmbH

Germany

Losan Pharma GmbH is a German full-service CDMO with 30 years of experience in the development and manufacturing of medicinal products, including solids, semi-solids, and liquids. The company's products are distributed in over 70 countries. Losan Pharma has been successfully inspected by the US FDA, ANVISA (Brazil), Saudi FDA, and Turkish authorities. The company specializes in improving API performance through enhanced bioavailability, stability, and customized release profiles.

Made Scientific

United States

Made Scientific is a US-based cell therapy CDMO specializing in development and GMP manufacturing of cell-based therapies including T cells, NK cells, HSCs, MSCs, iPSCs, and TILs. The company provides services from pre-clinical support through Phase I-III clinical trials and commercial enablement, including process and analytical development, GMP cell banking, drug product manufacture, aseptic fill and finish, and QC lot release and stability testing. FDA-registered with FEI number and operations including API manufacture, analysis, labeling, manufacturing, and packaging.

Magle Chemoswed AB

Sweden

Magle Chemoswed AB is a Swedish CDMO serving pharmaceutical and medical device companies with comprehensive services from development through manufacturing on a contract basis. The company operates a full cGMP and ISO 13485 production site in Malmo with five dedicated manufacturing suites. Services include analytical development, process development, solid state characterization, freeze drying (lyophilization), small-scale vial fill and finish, and inhalation drug product development. FDA inspected (3 inspections: 1 NAI, 2 VAI).

Maharshi Pharma Chem Pvt Ltd

India

Maharshi Pharma Chem Pvt Ltd is an Indian API manufacturer specializing in corticosteroid APIs since 2014. The company manufactures APIs to cGMP standards with expertise in developing corticosteroids for pharmaceutical companies producing topical, inhaled, and injectable formulations. Products include Betamethasone, Dutasteride, and other corticosteroid intermediates. The company operates from Ahmedabad, India.

Malladi Drugs & Pharmaceuticals Ltd

India

Malladi Drugs & Pharmaceuticals Ltd is a leading Indian API manufacturer founded in 1980, specializing in Ephedrine and Pseudoephedrine salts. The company exports APIs to over 60 countries and operates three FDA-registered facilities (3 FEI numbers). FDA inspection history shows 11 inspections (2 NAI, 8 VAI, 1 OAI) with latest in 2025. The company manufactures controlled substance APIs under strict regulatory oversight.

Matica Biotechnology

United States

Matica Biotechnology is a US-based viral vector and gene therapy CDMO that leverages advanced technologies at its purpose-built cGMP facility. The company specializes in viral vector manufacturing from development to commercialization with expertise in process development, assay development, and cGMP manufacturing. Matica Bio operates across five sites worldwide and offers proprietary technologies including MatiMax cell lines, in-line process monitoring, and single-use technologies for AAV, lentivirus, and other viral vector platforms.

Matrix Pharma Corp. Private Ltd. (CDMO BU)

India

Matrix Pharma Corp. Private Ltd. (CDMO BU) is a leading Indian integrated API manufacturer and CDMO specializing in active pharmaceutical ingredients with particular expertise in complex molecules, high-potency drugs, and APIs across therapeutic areas including antiretrovirals, antivirals, antihypertensives, cardiovascular, and CNS therapies. The company operates six state-of-the-art manufacturing facilities with over 3,850 kL installed capacity, including dedicated units for ARVs, peptides, and iron complexes. FDA-registered with 5 FEI numbers and extensive inspection history (25 inspections: 9 NAI, 15 VAI, 1 OAI). Recently inaugurated an oncology manufacturing facility in Vizag.

medac GmbH (medac CDMO)

Germany

medac GmbH operates a dedicated CDMO division (medac CDMO) offering end-to-end sterile injectable manufacturing services from clinical supply through large-scale commercial production. Based in Germany with facilities in Wedel and Dessau (Germany) and Brno (Czech Republic), medac specializes in small molecules, biologics (mAbs, proteins, peptides, oligonucleotides), and ADCs. They handle aseptic filling, terminal sterilization, lyophilization, and high-potent API processing down to OEL = 10 ng/m3. Manufacturing scales range from 1-50 L (small) to 50-1,500 L (large) with campaigns up to 11,000 L. They partner with Cerbios under the PROVEO brand for integrated ADC services. Over 40 years of regulatory expertise with approvals from multiple international health authorities.

MedPharm

United Kingdom

MedPharm is a UK-headquartered CDMO specializing in topical, transdermal, and transepithelial drug product development and manufacturing. Founded in 1999, MedPharm offers end-to-end services from early-stage formulation development through clinical supply to commercial manufacturing. Their 110,000 sq ft purpose-built facility in Durham, NC has successfully passed US FDA inspection for commercial manufacture. Services include formulation development, analytical and bioanalytical method development, clinical trial manufacturing, registration batches (PPQ & validation), commercial manufacturing, high potency product manufacturing, filling/packaging/serialization, and specialized in-vitro testing (IVPT, IVRT, skin permeation, nail permeation, RHE testing). MedPharm covers routes of delivery including dermal, gastrointestinal, mucosal, ophthalmic, otic, respiratory, ungual, and vaginal.

Medreich Limited

India

Medreich Limited is a fully integrated pharmaceutical company and CMO/CDMO headquartered in Bengaluru, India, with global presence including UK (Medreich PLC) and Australia. The company operates seven state-of-the-art manufacturing facilities and specializes in contract manufacturing of pharmaceutical preparations in various dosage forms for global regulated markets. Medreich offers services including proof of concept, formulation development, analytical services, clinical manufacturing, commercial manufacturing, and packaging design & development. The company has developed formulations as patent non-infringing and niche generics in differentiated dosage forms. Medreich is a subsidiary of Meiji Holdings Co., Ltd. Major clients include Sanofi, Berlin Pharma (Thailand), and others.

Melody Healthcare

India

Melody Healthcare Pvt Ltd is an Indian pharmaceutical company and part of The Singhania Group, specializing in the manufacturing of active pharmaceutical ingredients (APIs). The company focuses on niche, complex chemistry-driven APIs with expertise in respiratory and antibiotic therapeutic areas. Melody Healthcare has DMFs designed for global registrations and supplies APIs to over 105 countries. Key differentiators include micronization capability (particle size engineering from early-stage through commercial scale), backward integration from basic building blocks, and quality-by-design approach adhering to ICH guidelines. The company holds certifications from US-FDA, EDQM (ANSM France), TGA Australia, MFDS Korea, WHO-GMP, CDSCO, and ISO 9001/14001.

Meribel Pharma Solutions

France

Meribel Pharma Solutions is a mid-sized European end-to-end CDMO launched with 13 sites across France, Spain, and other European locations. The company specializes in sterile multidose products, sterile and non-sterile lyophilized products, API, sachets and stick packs, along with oral solid dose, liquid and semi-solid dosage forms. Meribel provides comprehensive services from development through commercialization including regulatory affairs, analytical development, process development, tech transfer, packaging, and manufacturing.

metabion

Germany

metabion is a German company and global leader in high-throughput custom oligonucleotide manufacturing, headquartered in Kirchheim near Munich. The company produces custom DNA and RNA products for scientific research, diagnostics, and therapeutic applications. metabion has expanded into therapeutic oligonucleotide manufacturing and partnered with BioSpring for CDMO services. The company is conducting a multi-million euro capacity expansion for both diagnostic and therapeutic oligonucleotides.

Metrochem API Pvt Ltd

India

Metrochem API Pvt Ltd is a vertically integrated Indian pharmaceutical API manufacturer based in Hyderabad, approved by USFDA (EIR), WHO-GMP, COEFPRIS, KFDA, and ISO 9001. The company has over 300 API and pellet registrations across various countries. Their manufacturing facility spans 50,000 sqm with 700kl reaction volume. Metrochem has received China NMPA approval for Teneligliptin hydrobromide and manufactures APIs such as Rabeprazole Sodium and Efinaconazole.

Microbiosci (Creative Biogene)

United States

Microbiosci (Creative Biogene) is a US-based biotech CDMO specializing in microbial fermentation-based production of commercial biological substances. The company provides GMP manufacturing services for recombinant proteins, recombinant pharmaceutical proteins, monoclonal antibodies, nucleic acid drugs, APIs, peptides, microbial metabolites, and enzymes. Their integrated platform includes strain development, fermentation process development, upstream/downstream processing, and fill-finish services.

Micro-Sphere SA

Switzerland

Micro-Sphere SA is a Swiss pharmaceutical CDMO based in Ticino, Switzerland, specializing in spray drying, capsule filling, and a wide range of R&D services. The company has a 100% regulatory track record, has served over 200 clients from all continents, and worked with over 500 drug substances and drug products. Micro-Sphere operates ISO 8 clean rooms and is FDA-registered for manufacturing. The company has a partnership with Sferalp and provides spray drying of both aqueous and organic solutions.

Midas Pharma GmbH

Germany

Midas Pharma GmbH is a German pharmaceutical company headquartered in Ingelheim, providing end-to-end services across the pharmaceutical value chain including contract development, contract manufacturing, supply chain management, regulatory affairs, quality and compliance, IP services, and reference product sourcing. The company has a particular specialization in Hot Melt Extrusion (HME) technology for high potent drugs with over 10 years of hands-on experience. Midas has FDA and EU GMP-certified manufacturing sites and offers contract manufacturing of finished dosage forms, intermediates, and drug substances. They also have a biosimilar pipeline including Ranibizumab.

Mikart, LLC

United States

Duplicate entry for Mikart, LLC -- same company as entries 16 and 17 (companyId a06bcecd and a06f4f1f). This is the same CDMO specializing in oral solid and non-sterile oral liquid dosage forms, headquartered in Atlanta, Georgia with 50+ years of experience, an FDA-registered facility, 82 approved products, and specialization in pediatric, geriatric, and controlled-substance formulations.

Miltenyi Bioindustries (Miltenyi Biotec)

Germany

Miltenyi Bioindustries (part of the Miltenyi Biotec group) is a German CDMO specializing in cell and gene therapy manufacturing. The company offers comprehensive CGT services including cell therapy process development, cell and gene therapy manufacturing, lentiviral vector production, and manufacturing technology platforms. Miltenyi has pioneered partnerships in cell and gene therapies for over 30 years and operates a global manufacturing network. The company has 2 FDA inspections on record and has conducted clinical trials in immunology and oncology.

Minakem (Minafin Group)

Belgium

Minakem, part of the Minafin Group, is a pharmaceutical CDMO with over 60 years of legacy in API development and manufacturing, headquartered in Belgium with production facilities in France, Belgium, and Canada. The company specializes in custom small molecule API and HPAPI development and manufacturing, with over 500m3 total reactor capacity. Minakem has 5 FDA-registered facilities performing API manufacture and analysis, has completed 19 FDA inspections (7 NAI, 12 VAI, 0 OAI), and recently expanded its API portfolio with 5 additional DMF holdings. The company also offers human and animal health APIs including Estradiol, Trenbolone, Fluvastatin, and Fulvestrant with an innovative Gen2 process reducing CO2 footprint.