Method Development & Validation CDMOs

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.

Gofarm Sp. z o.o. Sp.k

Poland

Gofarm Sp. z o.o. Sp.k is a Polish CDMO providing contract development and manufacturing services for pharmaceutical products, dietary supplements, and cosmetics. The company offers formulation development, analytical testing, stability studies, and commercial manufacturing for oral solid dosage forms, liquids, and semi-solid products. It operates from EU GMP-compliant facilities in Poland.

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.

Groupe SYNERLAB CDMO

France

Groupe SYNERLAB (now operating as Meribel Pharma Solutions) is a mid-size European CDMO with an integrated network of manufacturing sites across Europe, providing end-to-end services from API manufacturing through finished dosage forms. The company specializes in sterile multidoses, sterile and non-sterile lyophilized products, sachets, stick packs, oral solid dose, liquids, and semi-solids.

GTP Bioways

France

Duplicate entry of GTP Bioways (company ID 1f8658ec). GTP Bioways, acquired by Olon Group in 2024, is a French biologics CDMO specializing in process development and GMP manufacturing of monoclonal antibodies, recombinant proteins, bispecifics, ADCs, and nanodrugs across four sites in France.

Guangzhou RiboBio Co., Ltd.

China

Guangzhou RiboBio Co., Ltd. operates a CDMO/CMO platform (RiboPharm) that is Asia's largest GMP oligonucleotide API manufacturer, with over 20,000 sqm of planned production area. The company provides comprehensive oligonucleotide drug discovery, process and analytical development, CMC services, API production, and aseptic fill-finish, serving global pharmaceutical companies in bringing nucleic acid drugs from development to market.

Hapila GmbH

Germany

Hapila GmbH is an independent chemical-pharmaceutical CDMO based in Gera, Thuringia, Germany, specializing in the development and GMP manufacturing of active pharmaceutical ingredients, including high-potency APIs. The company provides services from early development through to market supply for approved medicinal products.

HAS Healthcare Advanced Synthesis SA

Switzerland

HAS Healthcare Advanced Synthesis SA, based in Biasca, Switzerland, is a full-service CDMO with over 40 years of experience in pharmaceutical development and manufacturing. The company recently acquired Cerbios-Pharma SA to create a leading international CDMO group, backed by 65 Equity Partners.

HealthTech BioActives (HTBA)

Spain

HealthTech BioActives (HTBA) is a Spanish company and global leader in citrus flavonoids and Vitamin B12 active forms, with over 45 years of experience. The company specializes in the clean production of naturally sourced active pharmaceutical ingredients and nutraceutical ingredients from its manufacturing facilities in Murcia, Spain.

High Force Research Ltd

United Kingdom

High Force Research Ltd (HFR) is an independent UK-based CRO and CDMO established in 1988, located in Durham. The company provides specialist chemistry-led research, development, and cGMP manufacturing services for the pharmaceutical, materials science, and fine chemicals industries. HFR bridges expertise from early-stage R&D through to commercial manufacturing with a chemistry-first approach.

HIKAL

India

HIKAL is an Indian CDMO established in 1988, headquartered in Mumbai, partnering with global pharmaceutical, biotech, agrochemical, and specialty chemical companies. The company provides contract research, process development, and commercial-scale API manufacturing. HIKAL operates five manufacturing facilities and recently inaugurated a new High Potency API (HPAPI) laboratory at its Pune Innovation Centre to expand CDMO capabilities.

Histocell

Spain

Histocell is a Spanish clinical-stage biopharmaceutical company and CDMO specializing in regenerative medicine and advanced therapy medicinal products (ATMPs). Based in the Basque Country, the company develops and manufactures cell therapy products from iPSCs, MSCs, secretomes, and exosomes. Histocell recently achieved GMP certification from AEMPS for iPSC manufacturing in partnership with REPROCELL, and has produced over 350 GMP batches treating approximately 300 patients from its 800 m2 EMA-registered facility.

Hokko Chemical Industry Co., Ltd.

Japan

Hokko Chemical Industry Co., Ltd. is a Japanese fine chemical company with over 70 years of expertise in organometallic chemistry, particularly Grignard reactions. The company provides CDMO services for pharmaceutical APIs and intermediates, as well as agrochemical intermediates. Hokko Chemical operates FDA-registered manufacturing facilities and holds DMF/CEP filings for API products.

Honour Lab Limited

India

Honour Lab Limited is an India-based CDMO providing end-to-end development and manufacturing of drug substance (APIs). The company offers services from route scouting and process development through preclinical and clinical supply to commercial API manufacturing, including specialty chemicals and GMP production.

Shenzhen Hybio Pharmaceutical Co., Ltd. (Hybio) is a Chinese pharmaceutical company founded in 1998, specializing in peptide drug R&D, manufacturing, and commercialization with a CRDMO division. The company focuses on peptide APIs (including semaglutide) and sterile injectable formulations, with products sold in 30+ countries. Hybio has 7 FDA-registered facilities and a strategic partnership with Dr. Reddy's for peptide API supply, and recently partnered with Huawei for AI-driven drug development.

ICON plc

Australia

ICON plc is a leading global clinical research organization (CRO) providing end-to-end drug development services. The company offers bioanalytical laboratory services, specialty laboratory solutions, clinical supplies management, regulatory consulting, and early clinical development across all phases of drug development. ICON operates globally with GMP-trained experts.

Ingenza Ltd

United Kingdom

Ingenza Ltd is a UK-based full-service protein CRDMO (Contract Research, Development and Manufacturing Organisation) headquartered in Edinburgh, Scotland. With over 20 years of experience, the company specializes in engineering biology for biologics and small molecule pharmaceuticals, offering services from drug discovery through pre-clinical manufacturing. Ingenza has a 100% success rate producing customer targets and has produced over 7,000 strains/cell-lines and proteins. GMP capability is coming online in Q2 2026.

Innovassynth Technologies (I) Ltd.

India

Innovassynth Technologies is a specialty chemicals and pharmaceutical intermediates manufacturer based in Khopoli, India. The company is a pioneer in offering commercial-scale nucleosides from India, and provides custom research, development, and contract manufacturing services across pharma intermediates, nucleosides, phosphoramidites, ADC linkers, organometallics, and specialty chemicals.

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).

Kingchem Life Science LLC

China

Kingchem Life Science LLC is a global small molecule CDMO specializing in the end-to-end development and manufacturing of APIs, intermediates, RSMs (regulated starting materials), excipients, and specialty chemicals. Their vertically integrated model spans from R&D through commercial production with facilities in St. Francis, Wisconsin (FDA-registered cGMP) and Fuxin, Liaoning, China, plus R&D in Dalian, China. They handle complex chemistry challenges, and their FDA facility (FEI 2129414) has had 9 inspections (1 NAI, 8 VAI, 0 OAI).

KINSY, S.L.

Spain

KINSY, S.L. is an independent Spanish CDMO with over 30 years of experience, located in Alhama de Murcia, specializing in the development, scale-up, and commercial production of pharmaceutical APIs and key intermediates under cGMP. They operate from a single site offering end-to-end services from early clinical stages through commercial manufacturing. KINSY is FDA-registered (FEI 3013310589) and holds ISO certification. They serve the fine chemical and pharmaceutical industry, working in close collaboration with partners on custom API synthesis.

KLEVA PHARMA (M.J. Kleva SA)

Greece

KLEVA Pharmaceuticals S.A. is a Greek pharmaceutical company established in 1974, specializing in contract manufacturing and technology transfer services. They operate two manufacturing sites in Greece, including a sterile area with filling capability expanded in 2019. KLEVA holds ISO 9001:2015 and EU GMP certification. Their R&D department develops generic pharmaceutical dossiers in CTD format, from patent search and API sourcing through formulation development, pilot-scale batches, stability studies, and dossier compilation. They have 190 marketing authorizations across Europe, Asia, Oceania, and Africa, serving over 50 customers in 30+ countries since 2012.

Kolon Biotech

South Korea

Kolon Biotech Inc. is a South Korean cell and gene therapy CDMO, part of the Kolon Group. They operate 17,000 sqm of facilities designed for both development and GMP manufacturing of cell and gene therapy products. Their B1 plant supports multiple simultaneous products and development projects, while B2 is optimized for mass production targeting global markets with flexible customization. Kolon Biotech is FDA-registered (FEI 3019016602) for analysis, API manufacture, labeling, manufacturing, and packaging. They offer end-to-end CDMO services aimed at shortening time-to-market, including a 2D Automated Closed Platform for large-scale adherent cell manufacturing.

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.

Latitude Pharmaceuticals Inc

United States

Latitude Pharmaceuticals Inc is a San Diego, CA-based CRO/CMO (CRDMO) providing innovative drug formulation development and GMP manufacturing services. Founded in 2003, the company has completed over 900 pharmaceutical formulation development projects for 250+ client companies. Specializes in solving complex drug formulation challenges, particularly for insoluble APIs using their proprietary CLEARSOL platform. Provides GLP- and GMP-compliant manufacturing and analytical testing services for IND-enabling studies and Phase 1-2 clinical trial materials, including sterile injectables, fill/finish, lyophilization, vials, pre-filled syringes, and IV bags.

LFB Biomanufacturing

France

LFB Biomanufacturing is a French CDMO specializing in end-to-end development and GMP manufacturing of therapeutic antibodies and recombinant proteins. Part of the LFB Group, the company provides services from cell line development through GMP drug substance manufacturing at its facility in Ales, France. The facility is FDA- and ANSM-inspected and approved.

Lupin Limited (Lupin Manufacturing Solutions)

Brazil

Lupin Manufacturing Solutions (LMS) is the CDMO arm of Lupin Limited, one of India's largest pharmaceutical companies. LMS offers integrated CDMO services spanning API manufacturing, formulation development, and finished dosage form production. They operate 16 FDA-registered facilities with 512 FDA-approved products. They have recently expanded into oncology with a dedicated block at Vizag, India, and formed a strategic alliance with PolyPeptide for peptide supply chain scaling. Their extensive regulatory track record includes FDA, WHO, and multiple international approvals.

MFC Co., Ltd.

South Korea

MFC Co., Ltd. is a South Korean company established in 2008 specializing in the manufacture of APIs and key pharmaceutical intermediates. The company is GMP certified by KMFDS (Korea Ministry of Food and Drug Safety). MFC focuses on both original and generic API development, from new drug candidate research to commercial-scale production. The company has also established an AI-based formulation research center and is involved in developing essential medicines including acetaminophen APIs.

Microsize, LLC

United States

Microsize LLC is a US-based pharmaceutical CDMO with over 30 years of specialized experience in micronization and particle size reduction, operating from three FDA-inspected facilities totaling over 100,000 square feet. The company helps drug developers improve dissolution and bioavailability for poorly soluble and highly potent APIs. Microsize has processed hundreds of APIs in thousands of production campaigns and recently signed an agreement to acquire Lonza's Micro-Macinazione assets. The company also licensed The Solubility Company's SPA platform for advanced particle engineering.

Mipharm S.p.A

Italy

Mipharm S.p.A. is a Milan-based pharmaceutical CDMO and one of the largest pharma CDMO sites in Italy. The company specializes in contract development and manufacturing of pharmaceutical products including production, packaging, R&D, and clinical trial logistics. 20% of staff is dedicated to quality. FDA-inspected (6 inspections, 1 NAI, 5 VAI).

Murli Krishna Pharma Pvt Ltd

India

Duplicate entry for Murli Krishna Pharma Private Ltd. (mkppl.com) - same company, same website domain. Indian pharmaceutical CDMO specializing in PFI and FDF products with CRAMS services.

Neuland Laboratories Ltd.

India

Neuland Laboratories is a global pure-play API CDMO headquartered in Hyderabad, India, established in 1984. The company specializes in the development and manufacturing of complex small molecule APIs and peptides, serving over 500 customers in 80+ countries. Neuland provides end-to-end services from pre-IND through commercial manufacturing with multi-product facilities.

Nippon Fine Chemical Co., Ltd.

Japan

Nippon Fine Chemical Co., Ltd. is a Japanese company providing CDMO services for lipid nanoparticles (LNP) and liposomes, along with manufacturing high-purity phospholipids, cholesterol, and functional lipids. The company established a new Shonan Lab at the Shonan Health Innovation Park for open innovation in pharmaceuticals. Nippon Fine Chemical's GMP system complies with ICH guidelines and has been inspected by US FDA and European EMA.

Nitto Avecia (incl. Nitto Avecia Pharma Services)

United States

Nitto Avecia (part of Nitto Denko Corporation) is a US-based CDMO specializing in oligonucleotide drug substance manufacturing with over 25 years of experience. The company provides comprehensive services from preclinical manufacturing (OliGrow service) through commercial scale, including analytical development, process development, drug substance manufacturing, process performance qualification (PPQ), quality control, and stability testing. It achieved ANVISA GMP certification in 2025.

NORCHIM (Norchim SAS)

France

Norchim SAS is a French fine chemical and API manufacturer, part of the Moehs Group. The company specializes in custom synthesis of pharmaceutical intermediates and active ingredients under GMP conditions, focusing on process R&D and pilot-scale production for clinical lots. Norchim has successfully passed FDA and French regulatory inspections and holds Japanese export accreditation.

Oligo Factory

United States

Oligo Factory is a Massachusetts-based custom DNA and RNA oligonucleotide CDMO providing GMP and RUO custom oligo solutions for therapeutics, diagnostics, and life sciences. The company has increased its synthesis capability 12-fold through a new 13,000 sq ft facility in Holliston, MA, producing from micrograms to hundreds of grams. Oligo Factory supports applications including ASOs, siRNA, CRISPR guide RNA, aptamers, and PCR/NGS diagnostics.

Oncotec Pharma Produktion GmbH is a German CDMO specializing in the development and aseptic manufacturing of cytostatic (anticancer) drugs. Founded in 1997, the company provides full-service contract manufacturing from lab-scale development through commercial production, with approximately 2,300 m2 of cleanroom space and isolator-protected production lines at its Dessau-Rosslau facility.

Onyx Scientific

United Kingdom

Onyx Scientific (now Onyx Atomica) is a small molecule CDMO specializing in process chemistry, solid state chemistry, and API manufacturing. The company provides integrated CMC services from process R&D and non-GMP scale-up through to GMP manufacture, operating from two facilities in Sunderland, UK with additional US presence.

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.

Panvo Organics Pvt Ltd

India

Panvo Organics Pvt Ltd is an Indian manufacturer of Active Pharmaceutical Ingredients (APIs), Nutraceutical Ingredients, novel formulations, and sustainable agriculture inputs. The company's manufacturing facility is US FDA inspected and WHO-GMP certified, spread over 100,000 sq ft in Gummidipoondi (near Chennai), Tamil Nadu. Products include pharmaceutical APIs, drug intermediates, and nutraceutical ingredients. The company holds a patent for novel Chitosan applications and has DSIR-recognized in-house R&D. Also listed as a top CMO for small molecule API manufacturing.

Parexel International (MA) Corporation

Argentina

Parexel is a global contract research organization (CRO) providing clinical trial management, regulatory consulting, and biopharmaceutical development services. With over 24,000 professionals and 50+ clinical sites across five continents, the company offers Phase I-IV clinical trial services, CMC regulatory strategy, and real-world evidence generation. Parexel is primarily a CRO, not a drug manufacturer.

Peptide Institute Inc.

Japan

Peptide Institute, Inc. has been contributing to the advancement of life sciences since 1977, serving over 10,000 scientists. The company provides both catalog peptide products for research and GMP peptide API manufacturing services from R&D through commercial scale. Peptide Institute offers custom peptide synthesis (including long peptides, modified peptides, cyclic peptides, glycopeptides), carbohydrate synthesis, and peptide drug production under GMP conditions.

Pharmaffiliates Private Limited

India

Pharmaffiliates Private Limited is an India-based CRDMO and impurity standard manufacturer that has been USFDA-inspected. The company provides pharmaceutical reference standards, impurities, metabolites, stable isotopes, API synthesis, analytical services, regulatory support (DMF/ANDA submissions), and GMP/GLP training. It serves pharmaceutical, biotech, API manufacturers, and CRO clients globally.

PharmaResources (Kaiyuan) Co., Ltd.

China

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

Pharmatory Ltd

Finland

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

PharmIdea is a Latvian CDMO located in Olaine, Latvia, specializing in sterile drug development, commercial production, and worldwide supply of pharmaceutical products. The company focuses on sterile drugs in vials, offering contract manufacturing services including product development. PharmIdea has completed CTDs for out-licensing and provides contract manufacturing of sterile injectables such as Levosimendan concentrate for solution for infusion (small batch), Caspofungin, and Carbetocin. The company has partnered with Lidds for manufacturing NZ-TLR9 formulation against solid tumors.

Piramal Pharma Solutions (PPS) is a global CDMO under Piramal Pharma Limited, offering end-to-end development and manufacturing solutions across the drug lifecycle. Operates through a globally integrated network of 17 development and manufacturing facilities across North America, Europe, and Asia, with distribution in 100+ countries. Services include drug discovery, process/pharmaceutical development, clinical trial supplies, and commercial supply of APIs and finished dosage forms. Specialized in highly potent APIs, antibody-drug conjugations, sterile fill/finish, and peptide products. Multiple CDMO Leadership Award winner.

Polpharma API

Poland

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