Microbiology Testing CDMOs

SGS

Brazil

SGS Integrated CDMO Solutions is the contract development and manufacturing division of the global testing and inspection company SGS SA. Established in 2002 with a specialized UK-based CDMO site (MHRA and FDA inspected), SGS provides formulation development, API manufacturing, sterile fill/finish, lyophilization, and analytical services. A new 55,000 sq ft cGMP facility in Hudson, NH expands their North American capabilities across Phase I-III clinical trials and commercial supply.

Sharp Sterile Manufacturing

United States

Berkshire Sterile Manufacturing (now Sharp Sterile Manufacturing, acquired by Sharp in 2023) is a specialist CDMO providing sterile injectable development and manufacturing services from its isolator-based facility in Lee, Massachusetts. All fills are 100% isolator-based using Colanar fillers, supporting clinical through small-to-mid-scale commercial production of vials, syringes, and cartridges. FDA-inspected with 8 inspections (7 NAI, 1 VAI), demonstrating strong regulatory compliance.

Siegfried Group

China

Siegfried Group is a leading global CDMO with 150+ years of pharmaceutical and chemical heritage, operating 13 production sites across Switzerland, Germany, Spain, France, Malta, the USA, and China. The company provides integrated services from early-phase API development through commercial-scale drug substance and drug product manufacturing, including exclusive synthesis, generic APIs, controlled substances, HPAPI handling, sterile formulations, and viral vector manufacturing through subsidiary DINAMIQS. In January 2026, Siegfried announced acquisition of additional US-based small molecule drug substance capacity.

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.

ABC Farmaceutici, an ICE Pharma company, is an Italian CDMO established in 1925 specializing in oral solid and liquid formulation manufacturing. Their 76,000 sqm facility in Ivrea (near Turin) is fully GMP certified and regularly inspected by AIFA and FDA. As part of ICE Pharma, they manage the entire drug supply chain from API through finished dosage form manufacturing.

Advaxia Biologics is a CDMO near Rome, Italy, specializing in adenovirus vaccine development and cGMP manufacturing. With over 10 years of biologics expertise and a 100% batch approval rate, Advaxia provides fully integrated services from expression systems and process development to analytical development and GMP manufacturing, and is EMA, FDA, and AIFA compliant.

AMPAC Analytical is part of SK pharmteco, a major integrated CDMO providing custom small molecule API development and manufacturing, viral vector and gene therapy CDMO services, and comprehensive analytical testing. SK pharmteco operates FDA/EMA/PMDA-inspected facilities across the US, Korea, Ireland, and France with capabilities spanning from clinical trials through commercial scale manufacturing.

Arevipharma GmbH

Germany

Arevipharma GmbH is a German CDMO based in Radebeul with nearly 150 years of corporate history in synthetic API manufacturing. They produce active pharmaceutical ingredients from gram scale up to several hundred tons per year under cGMP standards across five production scales. They serve small, medium, and large pharmaceutical customers worldwide with API manufacturing, registration, and marketing services. They are FDA-registered for API manufacture.

BBT Biotech GmbH

Germany

BBT Biotech GmbH is a German CDMO specializing in pharmaceutical active ingredients of biological origin. Based in Baesweiler near Aachen, they focus on fermentation (upstream processing) and protein purification (downstream processing) for the development, manufacture, and international distribution of biopharmaceuticals. They have had 1 FDA inspection with an OAI outcome.

BDI biotech

Spain

BDI biotech is a Spain-based biotech services company specializing in strain and bioprocess development, scale-up, and batch production. They serve three main fields: live biotherapeutic products (LBPs), cosmetics (biotechnological ingredients like enzymes and probiotics), and nutraceuticals (dietary enzymes, FOS, pre/probiotics). They operate as an outsourced R&D department for biotech development.

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.

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.

DPT Laboratories, LTD.

United States

DPT Laboratories, Ltd., a Mylan company with over 80 years of experience, is a leading CDMO specializing in semi-solid and liquid dosage forms including creams, gels, ointments, lotions, solutions, suspensions, emulsions, and aerosol formulations. The company provides integrated services from pre-formulation through commercial-scale cGMP manufacturing and packaging.

Formulated Solutions

United States

Formulated Solutions is a U.S.-based CDMO providing formulation development, analytical development, manufacturing, regulatory affairs, and packaging services for pharmaceutical and consumer health products. The company offers flexible manufacturing from small-scale clinical batches to large-scale commercial production across multiple dosage forms.

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.

Gaelic Laboratories Limited

Ireland

Gaelic Laboratories Limited is an Irish contract manufacturer specializing in Beta-Lactam (penicillin) products in tablet, capsule, and powder for suspension form. Established in 2022 on a site with 40 years of FDA-approved Beta-Lactam manufacturing history, the company serves EU, UK, and MENA markets. The facility spans 8,000 sqm across two GMP manufacturing plants on an 11-acre site, with HPRA licensing.

GMP Laboratories of America, Inc.

United States

GMP Laboratories of America, Inc. is a US-based CDMO providing contract development and manufacturing services for oral solid dosage forms, liquids, semi-solids, and topical products. The company offers formulation development, analytical testing, stability studies, and commercial-scale manufacturing from its FDA-registered facility. It serves pharmaceutical and dietary supplement markets.

Groupe PARIMA

Canada

Groupe PARIMA is a Canadian CDMO founded in 1994 specializing in the development and manufacturing of non-sterile liquids, suspensions, and semi-solid drug products. Operating from a 67,000 sq ft facility in Montreal, the company provides turnkey services from formulation development through commercial production, supplying drug products to over 30 global markets.

Grupo Medinfar

Portugal

Grupo Medinfar is a Portuguese pharmaceutical company founded in 1970, with an industrial unit that has provided contract manufacturing services for over 20 years. The company manufactures non-sterile solid, semi-solid, and liquid pharmaceutical products for third-party clients, offering turnkey and custom services including bulk manufacturing, packaging, analytical release, and scale-up support.

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).

Labcorp (incl. Labcorp Drug Development/Covance)

United States

Labcorp (including Labcorp Drug Development, formerly Covance) is one of the world's largest contract research organizations (CROs). They provide comprehensive drug development services including nonclinical development (toxicology, pharmacology, metabolism), central laboratory services (bioanalytical, biomarkers, genomics, companion diagnostics), and commercialization services. Labcorp supported 76% of all FDA-approved drugs in 2024. They operate across 100+ countries with services spanning from drug discovery to post-approval. While they offer CMC consulting services, their core business is contract research, not contract drug manufacturing.

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.

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.

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.

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.

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.

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.

Chongqing Carelife Pharmaceutical Co., Ltd. (Kailin Pharmaceutical) is a Chinese pharmaceutical company offering CDMO services for API manufacturing. The company has 2 FDA-registered facilities with 10 FDA inspections on record, producing APIs including clindamycin and amenamevir for domestic and international markets.

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.

FUJIFILM Biotechnologies (formerly FUJIFILM Diosynth Biotechnologies) is a global biologics CDMO operating 10 facilities across the US, UK, Denmark, and Japan with over 4,800 employees. The company provides end-to-end cGMP manufacturing services for biologics, advanced therapies, and vaccines, from preclinical through commercialization, with $8.6 billion invested in recent years and 20+ commercial licenses.

Goodwin Biotechnology (GBI) is a full-service biopharmaceutical CDMO based in Florida, specializing in biologics development and manufacturing. Named Manufacturer of the Year by BioFlorida, GBI offers its Single-Source Solution for monoclonal antibodies, ADCs, recombinant proteins, and other complex biologics from cell line development through cGMP commercial manufacturing. The company provides mammalian cell culture manufacturing using CHO and other expression systems.

Intertek

Canada

Intertek is a global quality assurance provider operating over 1,000 locations in 100+ countries, with specialized pharmaceutical services including GLP/GCP/GMP contract laboratory expertise, CMC analytical services, method development and validation, stability testing, and formulation development. The company has over 30 years of pharma experience with particular expertise in inhaled and nasal drug delivery systems and biopharmaceutical characterization.

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.

KBI Biopharma

Switzerland

KBI Biopharma is a global biologics CDMO (part of JSR Life Sciences) providing mammalian and microbial-based biopharmaceutical development and manufacturing services. Offers cell line development (SUREtechnology Platform powered by Selexis for CHO, PUREplatform for E. coli), process development, analytical development, formulation development, characterization, clinical and commercial GMP manufacturing. FDA registered (FEI 3004638264) with ANALYSIS, API MANUFACTURE, and MANUFACTURE operations. Positioned as a 'next-generation CDMO' with standalone services portal for analytical testing.

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).

Life Edit Therapeutics

United States

Life Edit Therapeutics is a gene editing R&D company and business unit of ElevateBio, focused on discovering and developing novel gene editing tools and technologies. The company collaborates with pharmaceutical companies like Novo Nordisk and Moderna on gene editing research. Life Edit is not a contract manufacturer; it is an internal R&D platform within ElevateBio.

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.

MabPlex International

China

MabPlex International is a China-headquartered CDMO providing comprehensive biomanufacturing services for the global biopharmaceutical and biotechnology industry. They offer innovative CRO and CMO services for biologics, with facilities in China and the USA (MabPlex USA). They are expanding CDMO services and manufacturing capacity to meet global biologics demand, with multiple manufacturing sites.

mAbxience

Spain

mAbxience, a Fresenius entity, is a global CDMO with 14+ years of experience in the development and manufacture of biopharmaceuticals, specializing in biosimilars and monoclonal antibodies. They are FDA-registered with two FEI numbers for analysis and API manufacture. They have partnered with HP to develop AI solutions for optimizing monoclonal antibody and biosimilar production. Their CDMO platform offers tailored solutions with quality, agility, and flexibility in manufacturing.

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.

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).

QPS (QPS Holdings)

Austria

QPS (QPS Holdings) is a global contract research organization (CRO) headquartered in Austria, providing bioanalysis, preclinical, and clinical research services. The company offers toxicology, pharmacology, DMPK, bioanalysis (800+ assays), PBMCs, central lab services, clinical trial units, and full clinical research support services across multiple therapeutic areas. QPS emphasizes agility, speed, and quality in drug development research but does not manufacture drugs.

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.

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.

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.

Stabicon Life Sciences Pvt.

India

Stabicon Life Sciences Pvt Ltd is an Indian Contract Research Organization (CRO) established in 2010, based in India. PharmaSource explicitly classifies them as a CRO. They provide support throughout all phases of product development including stability testing, formulation R&D, analytical R&D, microbial analysis, and technology transfer for OTC, nutraceutical, natural, and pharmaceutical products. Their services include analytical method development and validation, reverse engineering, stability programs (ICH), and formulation development using QbD principles. They work with pharma and FMCG companies worldwide. They also have a nutraceutical/dietary supplement and patented augmented absorption technology division. A related entity, Lyrus Life Sciences, is described as a CDMO, but Stabicon itself is primarily a CRO.

Texcell Group

China

Global CRO specializing in biosafety services for the pharmaceutical industry. Founded in 1987 at the Pasteur Institute in Paris to address HIV safety testing. Provides viral safety, biosafety testing, viral clearance studies, bioassays (in vitro and in vivo), and cell banking services for biologics, cell and gene therapies, and medical devices. Employs 140 people across offices and laboratories in France, US, Germany, China, Taiwan, and Japan. Also recently added BioManufacturing services, though the core business is contract testing/research, not drug manufacturing.

Veeda Lifesciences

India

Veeda Lifesciences (formerly Veeda Clinical Research) is a tech-driven global CRO headquartered in Ahmedabad, India with presence in 9 countries and sites across 26 geographies. They rebranded in January 2025 and now operate through four Strategic Business Units: Clinical Trials, Healthy Volunteer Services, Biopharma Services, and a fourth unit. Services include pre-clinical research, bioanalytical testing, clinical development for generics/innovators/biotherapeutics, real-world evidence, regulatory affairs, medical writing, pharmacovigilance, and data science. They have 2,100+ employees and are transitioning to a CRO-CDMO model per recent announcements, though their current core business remains contract research. Specializations include hemato-oncology, monoclonal/bispecific/trispecific antibody development, and multiple myeloma trials.