Microbiology Testing CDMOs

Wacker Biotech

Germany

Wacker Biotech is the CDMO division of Wacker Chemie AG, specializing in advanced biologics manufacturing including proteins, plasmid DNA, mRNA, LNP formulations, live microbial products, and vaccines. With over 30 years of experience and five GMP-compliant facilities in Germany, the Netherlands, and the United States, Wacker Biotech offers process development through commercial-scale manufacturing with E. coli-based technology platforms.

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.

Wheeler Bio

United States

Wheeler Bio is a biologics CDMO based in Oklahoma City, specializing in accelerating antibody-based therapeutics from discovery to cGMP clinical supply. The company uses its proprietary Modular CMC approach to reduce risk and accelerate timelines for drug developers. Wheeler Bio offers cell line development, process development, analytics, and manufacturing services for monoclonal antibodies, bispecific antibodies, and fusion proteins.

Afton Scientific

United States

Afton Scientific is a pharmaceutical CDMO with over 20 years of expertise in aseptic manufacturing for biologics and small molecules. The company operates FDA-inspected facilities with a 99.9% on-time delivery rate and is investing in multi-year expansion of sterile fill-finish capabilities, including new technologies for improved efficiency and increased production capacity.

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.

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.

Altasciences

Canada

Altasciences is a North American CRO/CDMO offering integrated early-phase drug development services. The company provides preclinical safety testing, clinical pharmacology (Phase I-II), bioanalysis, and manufacturing/analytical services including formulation development, drug product manufacturing (tablets, capsules, suspensions, creams, terminally sterilized injectables), and ICH stability testing, with DEA licensing for Schedule I-V substances.

Andelyn Biosciences

United States

Andelyn Biosciences is a gene therapy and viral vector CDMO with deep expertise in the development and production of viral vectors. The company has produced 450+ cGMP clinical batches, supported 75+ INDs, and operates 225,000+ sq ft of facility space. Andelyn offers viral vector manufacturing, plasmid manufacturing, process development, and laboratory services, with a proprietary AAV Curator platform.

Applied Laboratories, Inc.

United States

Applied Laboratories, Inc. is a cGMP contract manufacturer headquartered in Columbus, Indiana, specializing in liquids, semi-solids (creams, ointments, gels), and topical pharmaceutical products. Originally founded in 1984 as an FDA regulatory consulting firm, it evolved into a full-service contract manufacturer with 200,000 sq-ft of cGMP facilities registered for both drug and medical device production. They provide formulation development through commercial-scale manufacturing, filling, labeling, and packaging for OTC pharmaceuticals and healthcare products.

Argenta (Animal Health CRO/CDMO)

Germany

Argenta is the world's only global animal health contract research, development, and manufacturing organization (CRO/CDMO). They provide end-to-end support for veterinary medicinal products including immunologicals/vaccines, biological non-immunologicals, pharmaceuticals, and novel therapies. They offer contract manufacturing for both sterile and non-sterile animal health products, with FDA-registered facilities across multiple sites globally. Note: they serve the animal health market, not human pharmaceuticals.

Argonaut Manufacturing Services

United States

Argonaut Manufacturing Services is a U.S.-based CMO headquartered in Carlsbad, California, specializing in aseptic fill and finish, lyophilization (LyoDose beads, LyoDots, powders, and cakes), in-vitro diagnostics (IVD) and life science kit manufacturing, and drug-device combination products (DDCP). They recently secured $45M in financing to expand their aseptic fill/finish capabilities. They serve pharmaceutical, life science, IVD, and applied markets from small N-of-1 fills to high-scale commercial products.

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.

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.

BioCina

Australia

BioCina is a global end-to-end biologics CDMO and the only biologics CDMO in Australia approved by the US FDA. Following the merger with NovaCina, the company provides comprehensive biologics CDMO services spanning cell line development, process development, analytical development, GMP manufacturing of biologics drug substance and drug product, and mRNA manufacturing. Operates facilities in Adelaide, Australia with GMP manufacturing capacity up to 1,000L bioreactors.

BioConnection

Netherlands

BioConnection is a contract manufacturing organization (CMO) based in Oss, The Netherlands, specializing in aseptic fill and finish services for sterile drug products. The company offers flexible development and GMP-compliant manufacturing for both innovative and generic biopharmaceutical companies, with capabilities in vials, syringes, and lyophilized products. Partnered with AGC Biologics for drug product services. FDA-registered with 17 inspections (6 NAI, 11 VAI), demonstrating extensive regulatory history.

Biofortuna

United Kingdom

Biofortuna is a specialist contract development and manufacturing organization (CDMO) focused on diagnostic and life science applications. Based in the UK, the company provides assay development, lyophilization (particularly lyophilized reagent beads), dispensing, kitting, labeling, packaging, stability storage, and DNA extraction services. Biofortuna serves life science innovators with end-to-end outsourcing for diagnostics manufacturing. FDA-inspected (1 VAI). Recently tripled lyo bead output with bespoke robotic manufacturing.

Biologics Manufacturing Centre (BMC) Inc.

Canada

Biologics Manufacturing Centre (BMC) Inc. is a Canadian end-to-end GMP biomanufacturing facility with a public good mandate, established to secure domestic biologics supply. Licensed by Health Canada (DEL 3-002766-A and 3-002818-A) to manufacture and test biological products and vaccines. The facility is BSL-2 accredited and supports orphan drug development for rare and genetic diseases. Subsidiary of the National Research Council Canada.

Biopharma Group CDMO

United Kingdom

Biopharma Group is a UK-headquartered CDMO specializing in lyophilized (freeze-dried) and liquid pharmaceutical formulations for clinical manufacturing. They offer services from R&D through technical transfer, engineering batches, and clinical manufacturing to Annex 1 GMP standards. The company can handle substances classified up to OEB 6 and also manufactures non-sterile diagnostic formulations. They operate three Category D cleanrooms and a dedicated lyophilization center.

Bioprox SA (Bioprox Cultures / Bioprox Healthcare)

France

Bioprox SA operates two divisions: Bioprox Cultures (lactic acid starter culture production -- lyophilized ferments for dairy industry) and Bioprox Healthcare (probiotics and postbiotics toll manufacturing). With 50+ years of experience, 800+ clients, 120+ employees, and exports to 40+ countries. They offer custom culture development, toll manufacturing of proprietary probiotics/postbiotics, and R&D services. ISO 9001 and FSSC 22000 certified, with Halal and Kosher certifications. They are NOT a pharmaceutical manufacturer -- they produce live microbial cultures and probiotics.

Birgi Mefar Group (BMG)

Turkey

Birgi Mefar Group (BMG) is one of Turkey's leading producers of sterile injectable products, recently acquired by Abu Dhabi-based ADQ. The company provides contract manufacturing services for sterile injectables with manufacturing sites in Turkey. BMG is listed on pharmaceutical CDMO directories and provides fill-finish and sterile manufacturing services.

Bliss GVS Pharma Ltd.

India

Bliss GVS Pharma Ltd. is an Indian pharmaceutical company and the world's largest manufacturer of suppositories and pessaries, operating in 60+ international markets. The company operates six manufacturing units in Maharashtra and Daman with WHO-GMP and EU-GMP (PIC/S) approvals, producing suppositories, pessaries, tablets, dry syrups, dry powder injectables, ointments, creams, and gels. Bliss GVS offers contract manufacturing (CMO/CDMO) services alongside its own product portfolio.

Bluepharma

Portugal

Bluepharma is a Portuguese CRDMO with over 55 years of experience, offering an integrated approach from R&D through to commercial manufacturing of medicines. The company produces 2 billion units of oral solid pharmaceutical forms and has an industrial plant for high potency products. Bluepharma's facilities are EMA/Infarmed and FDA approved, and the company has expanded into advanced therapies beyond small molecules.

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.

Custom Pharma Services

United Kingdom

Custom Pharma Services is a UK-based CDMO founded in 1979 in Brighton, specializing in oral solid dose manufacturing and packaging for clinical and commercial use. The company is MHRA-approved and FDA-inspected, with capacity exceeding 1.5 billion tablets and 250 million capsules annually. Custom Pharma handles controlled drugs, hormonal products, and has launched Centrix Pharma Solutions for early-stage development.

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.

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.

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.

Fraunhofer Institute for Cell Therapy and Immunology (IZI)

Germany

The Fraunhofer Institute for Cell Therapy and Immunology (IZI) in Leipzig is a contract research and GMP manufacturing institute specializing in cell and gene therapy, vaccines, and biologics. The institute provides GMP-compliant manufacturing of clinical trial materials (ATMPs and biologicals), process development for pharmaceutical manufacturing, and regulatory support for manufacturing authorizations and approvals.

Global Pharma HealthCare (India)

India

Global Pharma HealthCare is an Indian pharmaceutical CDMO offering contract development and manufacturing services for sterile and non-sterile dosage forms. The company provides end-to-end services from formulation development through commercial manufacturing, including oral solids, liquids, sterile injectables, and lyophilized products. It serves regulated markets including the US, EU, and other global markets.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Minaris Advanced Therapies

United States

Minaris Advanced Therapies (formerly Hitachi Chemical Advanced Therapeutics Solutions) is a global cell and gene therapy CDMO with 25+ years of autologous expertise. The company provides end-to-end GMP manufacturing and advanced testing services for gene-edited autologous (CAR-T, TCR-T), allogeneic (NK, HSC, iPSC), non-edited cell therapies, and vaccines. FDA-registered manufacturing site with FEI number.

NextPharma

Finland

NextPharma is a European pharmaceutical CDMO headquartered in Finland with 10 manufacturing sites across Europe. The company provides pharmaceutical development, clinical trial supply, commercial manufacturing, packaging, and analytical services across a wide range of dosage forms including solids, semi-solids, liquids, softgel capsules, ophthalmics, modified release products, and specialist areas such as hormones, cephalosporins, penicillins, and narcotics.

QuVA Pharma

United States

QuVA Pharma is a US-based FDA-registered 503B outsourcing facility specializing in sterile compounding of ready-to-administer injectable medicines for hospitals. They serve over 3,000 US hospitals and operate multiple manufacturing and forward distribution centers. They also offer AI-powered analytics (Quva BrightStream) for health-system pharmacy data insights. Notable regulatory history includes multiple OAI inspections and Class I/II recalls.

Recipharm AB

Sweden

Rechon Life Science AB is a subsidiary/entity within the Recipharm group, the global CDMO headquartered in Stockholm, Sweden. This entry represents the same Recipharm organization (same website: recipharm.com) with its extensive global manufacturing footprint of 15+ FDA-registered FEI numbers and 52 FDA inspections. The Perplexity research confirms Recipharm's specialization in oral solid dose, inhalation, sterile manufacturing, and HPAPI capabilities. Rechon may represent a specific Recipharm site or legacy entity. Duplicate of Recipharm AB entry -- capabilities are identical.