Microbiology Testing CDMOs

UPM Pharmaceuticals

United States

UPM Pharmaceuticals is a U.S.-based CDMO specializing in late-stage commercial manufacturing of semi-solid and oral solid dose products. Operating from a 475,000 sq ft cGMP FDA-registered facility in Bristol, Tennessee, UPM is a family-owned company with 30+ years of experience. They handle DEA-controlled substances and provide services from technology transfer and scale-up through commercial manufacturing. Capabilities include formulation development, analytical development, coated tablet manufacturing, pharmaceutical serialization, aggregation, and full packaging and warehousing.

Bespak

United Kingdom

Bespak is a specialist CDMO focused exclusively on inhaled and nasal drug delivery devices (pressurized metered-dose inhalers, dry powder inhalers, nasal sprays). Built on decades of experience designing, developing, and manufacturing inhaled drug delivery devices and drug products. FDA-registered with 6 inspections (2 NAI, 4 VAI). Operates from Holmes Chapel, UK facility with extensive device development and manufacturing capabilities.

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.

Charles River Laboratories

Australia

Charles River Laboratories is a global contract research organization (CRO) providing drug discovery, safety assessment, and preclinical services across the drug development lifecycle. The company recently divested its CDMO business, indicating it is focused on research services rather than contract manufacturing. It has extensive FDA-registered facilities worldwide.

keyhan daroo

United Kingdom

Keyhan Daroo is an agile and innovation-driven pharmaceutical technical services and consulting enterprise dedicated to delivering high-quality development, formulation, and quality compliance solutions. We specialize in transforming laboratory-scale chemical synthesis into robust, commercial-ready pharmaceutical products, with a core focus on solid dosage forms (tablets and capsules) and Active Pharmaceutical Ingredients (APIs). Operating with a strong commitment to international standards, Keyhan Daroo provides comprehensive support in establishing and optimizing Quality Assurance (QA) and Quality Control (QC) systems. Our technical capabilities include advanced in-vitro dissolution profiling, process engineering utilizing modern mini-reactor systems, and executing smooth technology transfers. Driven by a team of experienced pharmacists and chemical engineers, we help our global partners navigate complex CMC requirements, upgrade manufacturing facilities to meet strict PIC/S and EU GMP guidelines, and ensure total regulatory readiness. At Keyhan Daroo, we bridge technical precision with scalable pharmaceutical excellence.

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.

Helba İlaç İç ve Dış San. Tic. A.Ş.

Turkey

Helba Pharma is a Turkish pharmaceutical manufacturer established in 2008, with roots in Welfar Pharma founded in Azerbaijan in 1995. The company produces solid and semi-solid form medicines at its GMP-certified production facility with 50 million box manufacturing capacity, and actively exports to CIS countries, Balkans, and Middle Eastern markets.

KD Pharma Group

Germany

KD Pharma Group is a pure-play, technology-driven CDMO with unique expertise in lipids (omega-3 APIs from fish and algae) and specialized small molecule products. Offers vertically integrated services: API manufacturing (lipid-based and small molecule), finished dosage forms (softgels, liquid bottling, packaging). Pharma division (KD Pharma) provides pharmaceutical APIs and custom synthesis. Nutra division (KD Nutra) serves nutritional supplement companies. KD Biopharma runs Phase 3 clinical trials for lipid-based therapeutics (FAP, UC, COVID-19). Recently expanded manufacturing site in Seal Sands, UK. FDA registered with 2 FEI numbers, 3 inspections (3 VAI).

Forge Biologics (Ajinomoto Group)

United States

Forge Biologics, acquired by Ajinomoto Group in 2023 for $554-620 million, is a gene therapy CDMO specializing in high-purity adeno-associated virus (AAV) vector and plasmid manufacturing. The company operates a 200,000 sq ft Hearth facility in Columbus, Ohio with 20 cGMP suites and 20,000L bioreactor capacity, providing end-to-end services from preclinical process development through commercial manufacturing.

Curida

Norway

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

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.

BioReliance (Merck KGaA, MilliporeSigma)

Scotland

BioReliance is the contract testing services division of Merck KGaA (MilliporeSigma), providing GMP-compliant biosafety testing, product characterization, and quality control testing for biologics, vaccines, and cell/gene therapies. With 25 FDA-registered FEI numbers and 102 FDA inspections across global sites, they are one of the largest contract testing organizations. They provide end-to-end testing solutions but do NOT manufacture drug substances or drug products -- they are a testing CRO.

MassBiologics, a division of UMass Chan Medical School, is a US-based biologics CDMO with over 100 years of history driving discoveries to products. The organization develops novel biologics for diseases of public health importance and offers CMO services including bulk drug manufacture of monoclonal antibodies, vectored therapeutics (gene therapy), and aseptic fill finish. The facility includes approximately 25,000 sq ft of cGMP manufacturing space with dedicated aseptic fill finish and bulk drug substance areas. FDA-registered with 3 FEI numbers. Produces the FDA-licensed Td vaccine and has partnerships for gene therapy manufacturing (SparingVision, PTC Therapeutics).

ARL Bio Pharma

United States

ARL Bio Pharma is a U.S.-based contract testing laboratory headquartered in Oklahoma City, providing analytical and microbiological testing services for the pharmaceutical industry. They serve compounding pharmacies, outsourcing facilities, and pharmaceutical manufacturers with comprehensive laboratory quality testing including analytical testing, microbiology testing, raw material testing, forensics testing, and bioanalytical testing. They are FDA-registered for analytical operations.

Biose Industrie

France

Biose Industrie is a French CDMO specialized in microbiome therapeutics, established in 1951. They focus on manufacturing Live Biotherapeutic Products (LBPs) and Next-Generation Probiotics (NGPs) for pharmaceutical and consumer health markets. They combine aerobic and anaerobic microbiology expertise with industrial-scale GMP manufacturing. Investing EUR 80 million to expand capacity from 8,000L to 32,000L fermentation volume at their Aurillac site. They offer full CDMO services from process development to GMP drug product manufacturing.

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.

ReciBioPharm (now Recipharm Advanced Bio) is the advanced therapies division of Recipharm, a global CDMO devoted to process development and GMP manufacturing for advanced therapeutics including xRNA therapies, viral vectors, microbial/live biotherapeutic products, and recombinant proteins. They offer end-to-end services from preclinical development to commercial manufacturing, with operations on two continents. They have partnerships with the University of Oxford, NewBiologix (AAV cell lines), LenioBio, and Hongene Biotech.

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.

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.

Accugen Laboratories, Inc.

United States

Accugen Laboratories is a contract microbiological quality control, research, and testing services laboratory based in Willowbrook, Illinois. They specialize in pharmaceutical microbiology testing, cosmetics and personal care microbiology testing, and environmental monitoring. Note: the website at accugen.com belongs to ACUGEN Software (a test generation software company), not Accugen Laboratories.

Fortrea

United States

Fortrea is a leading global contract research organization (CRO) spun off from Labcorp in 2023, providing Phase I through IV clinical trial management, clinical pharmacology, and market access solutions for biopharma and MedTech companies. While Fortrea has some onsite Phase I manufacturing capability for small molecule clinical supplies, its core business is clinical trial services, not contract drug manufacturing.

AB Biotechnology Ltd

United Kingdom

AB Biotechnology Ltd is a UK-based biologics CDMO located at Pentlands Science Park near Edinburgh. They specialize in development and GMP manufacturing of high-purity biopharmaceutical products including proteins, peptides, and polyclonal antibodies. Their MHRA-licensed facility includes cleanroom suites for purification, viral inactivation/reduction, fill/finish, and lyophilization for injectables.

Kaneka Eurogentec (part of Kaneka Group, Japan) is a Belgian CDMO established in 1985, FDA inspected, GMP accredited. Manufactures starting materials and APIs for clinical and commercial phases. Core products: GMP plasmid DNA (gram to kg scale), GMP recombinant proteins and antibody fragments, GMP mRNA (50g per batch, commercial-ready facility accredited June 2025), GMP oligonucleotides (pre-clinical and Phase 1/2), GMP conjugates. Also supplies research-grade oligonucleotides and diagnostic tools. 475 employees. FDA registered with 2 FEI numbers, 7 inspections (1 NAI, 6 VAI). Plasmid DNA serves as starting material for viral vector and mRNA production.

Centre c3i

Canada

C3i Center Inc is the first CDMO in Canada to receive approval for a Drug Establishment License to commercially produce cell therapy drug products. Based in Montreal, the company provides tailored cell and gene therapy CDMO services from development through commercial manufacturing.

Conscio Group

Austria

Conscio Group is a European scientific service provider headquartered in Munich, Germany, offering laboratory services across pharmaceuticals, food, and environmental sustainability. The pharma division provides formulation development, analytical R&D, bioanalytical testing, clinical trials, IMP manufacturing, batch release testing, biologics and biosimilars testing, microbiology, and pharma analysis. Conscio operates GMP/GCP/GLP and FDA-certified laboratories in Germany, Czech Republic, Austria, and Slovakia.

Aizant Drug Research Solutions

India

Aizant Drug Research Solutions Pvt. Ltd., founded in 2008, is a trusted global CDMO offering comprehensive API and Formulation R&D, CDMO, CMO, and CRO services across multiple therapeutic areas and dosage forms. The company operates USFDA and EU-accredited facilities with capabilities in hot melt extrusion, spray drying, and complex generics, providing end-to-end pharmaceutical development and manufacturing solutions.

53 Biologics

Spain

53 Biologics is a Spanish CDMO specializing in biologics production from plasmid DNA to proteins. They provide services from preclinical development to cGMP manufacturing, with over 4,500 sqm of facilities including microbial and mammalian manufacturing lines. They hold ISO 9001, ISO 13485, ISO 14001 certifications and operate under GMP.

Bilim Pharmaceuticals

Turkey

Bilim Pharmaceuticals is a major Turkish pharmaceutical company with comprehensive manufacturing capabilities across three production facilities in Gebze and Cerkezkoy. Provides contract manufacturing services alongside its own branded portfolio. Facilities produce a wide range of dosage forms including solid oral doses, liquids, semi-solids, sterile injectables, and inhalation products. Subject to international regulatory inspections and has clinical trials experience.

I Peace Inc. is a Palo Alto, California-based biotech CDMO specializing in cGMP manufacturing of iPSC (induced pluripotent stem cells) and iPSC-derived cell products for cell and gene therapy development. The company provides custom GMP cell manufacturing, process development, cell banking (MCB/WCB), gene editing, differentiation services, and regulatory support compliant with FDA, PMDA, and EudraLex standards. I Peace has manufactured 100+ GMP iPS cell lines and tripled its CDMO facility capacity.

CARBOGEN AMCIS

CHina

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

Solvias

Germany

Solvias is a global cGMP contract research organization (CRO) founded in 1999 with 800+ employees across 5 locations worldwide. The company provides comprehensive analytical services for small molecules, biologics, and cell and gene therapies, including release testing, stability studies, extractables/leachables testing, and biosafety testing. Solvias also offers API development and manufacturing services for small molecules up to Phase III.

Fresenius Kabi iPSUM S.r.l.

Italy

Fresenius Kabi iPSUM S.r.l. is the Italian subsidiary of Fresenius Kabi, a global healthcare company with significant CDMO operations specializing in lifesaving medicines for critically and chronically ill patients. The company has extensive FDA-registered manufacturing facilities with 405 FDA-approved products, and provides contract development and manufacturing services for injectable, infusion, and other sterile pharmaceutical products.

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.

Akron Biotech

United States

Akron Biotech is a leading contract manufacturing organization (CMO/CDMO) providing cGMP-compliant solutions for cell and gene therapy. The company manufactures cytokines, growth factors, media, buffers, and transfection/transduction reagents, and recently expanded to a second 60,000 sq ft biologics manufacturing facility in Sarasota, Florida, to support growing demand for ancillary materials in cell and gene therapy.

BMI Korea

South Korea

BMI Korea is a South Korean CDMO offering contract development and manufacturing services spanning small molecule APIs, oral solid dosage forms, biologics, vaccines, and mRNA products. The company provides integrated services from formulation development through commercial-scale manufacturing with cGMP-compliant facilities.

Emil Pharmaceutical Industries Pvt Ltd

India

Emil Pharmaceutical Industries Pvt. Ltd. is an Indian CDMO founded in 1989, headquartered in Mumbai with three manufacturing units in MIDC Tarapur, Maharashtra. The company manufactures pharmaceuticals, nutraceuticals, and OTC formulations including tablets, capsules, powders, liquids, creams, and ointments. Emil has partnered as a CDMO with global companies including Abbott, Mylan, Pfizer, GSK, USV, and MSD, and exports to over 25 countries with certifications from WHO, ISO 9001, NAFDAC Nigeria, and FDA Ghana.

Alcami

United States

Alcami is a US-based CDMO with 45+ years of experience providing integrated drug product manufacturing, laboratory services, and cGMP pharmaceutical storage. The company specializes in sterile fill-finish manufacturing (liquid and lyophilized injectables, prefilled syringes) and oral solid dose, with DEA licensing for controlled substances and EU/Annex 1 compliance.

LOTTE BIOLOGICS

South Korea

LOTTE BIOLOGICS is a global biologics CDMO headquartered in South Korea, offering end-to-end development and cGMP manufacturing services for biological Drug Substance. Operates the Syracuse Bio Campus (New York, USA) with 40,000L capacity and the Songdo Bio Campus (Incheon, South Korea) planned for 120,000L by 2027. Also operates a $100M ADC manufacturing facility.

Reig Jofre (Laboratorio Reig Jofre, S.A.) is a Spanish pharmaceutical company founded in 1929 that operates both as a pharmaceutical company with its own products and as a CDMO. They have four development and production centres in Europe (two in Toledo, one in Barcelona, one in Sweden) with over 1,100 employees. Their CDMO capabilities include sterile lyophilizates, sterile liquids, non-sterile liquids, and beta-lactam manufacturing. Known for excellence in freeze-drying technology and advanced sterile manufacturing. FDA-registered with manufacturing and analysis operations, though regulatory history shows 3 OAI inspections.

Benuvia Operations, LLC

United States

Benuvia Operations, LLC is a US-based specialized CDMO and API supplier focused on controlled substances. They pioneer work with cannabinoids, psychedelics, and traditional pharmaceuticals, offering a unified services platform from IND-enabling through commercial manufacturing. They hold DEA registrations and are FDA-registered for API manufacture, analysis, labeling, manufacturing, and packing. Their SYNDROS (Dronabinol) CII product demonstrates their controlled substance expertise.

Dalton Pharma Services

Canada

Dalton Pharma Services is a Canadian CDMO and subsidiary of Seikagaku Corporation Japan, providing integrated drug discovery, development, and manufacturing services. The company is FDA-inspected and Health Canada-approved with over 35 years of experience, specializing in custom chemical synthesis, cGMP API manufacturing, sterile vial filling, and formulation development including liposomal formulations. Dalton recently announced major expansion of its commercial sterile manufacturing capacity.

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.

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.

Artesan Pharma

Germany

Artesan Pharma is a German full-service CDMO based in Luechow, specializing in pharmaceutical contract development and manufacturing with 501-1,000 employees. They provide services spanning formulation development to commercial manufacturing across multiple dosage forms including oral solid doses (tablets, capsules, pellets), sterile prefilled syringes with innovative production processes, and liquids. They also offer serialization, final packaging (blister), and terminal steam sterilization capabilities.

PPD (Pharmaceutical Product Development) is a leading global contract research organization (CRO) providing clinical research solutions across 20+ therapeutic areas. The company offers end-to-end drug development services including clinical trial management, bioanalytical laboratory services, biostatistics, regulatory consulting, and functional service provider solutions. PPD does not manufacture drugs.

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.

MSN Laboratories

India

MSN Laboratories is a Hyderabad-based major pharmaceutical CDMO with $1.2 billion in revenue. The company operates 15 API facilities and 6 finished dosage form (FDF) facilities across India and the USA (Novadoz Pharmaceuticals). MSN offers CRAMS (Contract Research and Manufacturing Services) with 200+ first-to-market generics and 400+ formulations. Specialized capabilities include cytotoxics, high-potency APIs, peptides, prostaglandins, and biosimilars. FDA-registered with 14 FEI numbers, 31 FDA inspections (16 NAI, 15 VAI — strong track record), and 119 FDA-approved products. Has established an advanced E&L (Extractables and Leachables) Laboratory.