Method Development & Validation CDMOs

Grace Fine Chemical Manufacturing Services is the pharmaceutical CDMO arm of W.R. Grace & Co., providing contract drug substance manufacturing including custom APIs, registered starting materials, and generic APIs. This entity appears to represent the China-based operations of Grace's pharmaceutical fine chemicals division, operating alongside the US facilities in South Haven and Tyrone.

J‑STAR Research, Inc.

United States

J-STAR Research is a contract process R&D and cGMP manufacturing organization (subsidiary of Porton Pharma Solutions) serving the pharmaceutical and biotech industry. Founded 1996, focused on small molecule drug substance and drug product development. Offers process chemistry R&D, crystallization R&D, high potent compound handling, controlled substances, analytical R&D, QC, and drug product formulation. Two NJ-based R&D centers totaling 129,000 SF. FDA registered with API MANUFACTURE operations.

Key Organics Limited is a UK-based custom synthesis and contract chemistry company, home of the BIONET screening compound collection of 344,000+ products. They offer fee-for-service synthetic organic chemistry, process development and scale-up (gram to kilogram scale), analytical services, fragment-based screening libraries, compound procurement, and consultancy. They operate at non-GMP kilo-scale for intermediates and do process development for GMP manufacture, but are primarily a research chemistry services company rather than a full cGMP API manufacturer. They work with clients in pharma, biotech, academia, and agrochemicals.

M2i Life Sciences

France

M2i Life Sciences is a French industrial group founded in 2012, specializing in the design, formulation, and production of complex molecules. Their CDMO division focuses on research, development, and production of active pharmaceutical ingredients (APIs), synthesis intermediates, specialty molecules, and pheromones. They operate across human health, animal health (veterinary formulation and microencapsulation), and biocontrol segments. They produce approximately 1,000 tonnes per year of reference products in pain relief, fever control, and cardiology for France and North Africa.

Mac-Chem Products (India) Pvt. Ltd.

India

Mac-Chem Products (India) Pvt. Ltd., part of the NMM Group (Naprod), is a pharmaceutical API manufacturer specializing in Oncology, General APIs, and Bulk Sterile products. They have manufacturing plants in four locations employing around 800 professionals. Naprod (parent) is a pioneer in lyophilization with an ultra-modern manufacturing facility. They hold multiple international regulatory approvals including USFDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, and WHO-GMP/ISO certifications.

Macrocyclics, Inc.

United States

Macrocyclics, Inc., founded in 1995 and headquartered in Plano, Texas, is a specialist CDMO for chelating agents used in radiopharmaceuticals. Their products support drug development programs worldwide by providing the chelators that attach radioactive isotopes to targeting vectors for cancer treatment. They offer GMP manufacturing with an advanced quality system for translating new molecules into clinical research, as well as research collaborations.

Morgen Pharmaceutical Services (MPhS), operating as Stason Pharmaceuticals, is a US-based CDMO offering end-to-end drug development and manufacturing services. Located in Irvine, California, the facility can produce over 2 billion oral doses per year with batch sizes from 0.5 kg to 600 kg. The company offers API synthesis (through offshore affiliates), formulation development, pre-formulation studies, solid dosage manufacturing (tablets and capsules), high-containment operations for highly potent compounds (OEL < 1 µg/m³), and injectable/liquid manufacturing through a partner facility in Tainan, Taiwan. FDA-registered with 2 FEI numbers and 11 FDA inspections (8 NAI, 3 VAI).

Indian pharmaceutical CDMO specializing in pre-finished formulation intermediates (PFI) and finished dosage forms (FDF). Manufactures oral solids, oral liquids, injectables, ophthalmics, topicals, and inhalation products. Strong focus on pellet technology and nanotechnology-based drug delivery systems. CRAMS (Contract Research and Manufacturing Services) provider.

Nanomol Technologies S.A.

Spain

Spanish company specializing in particle design, nanoformulation, and cGMP particle characterization services. Uses proprietary DELOS platform technology for nanoformulation and drug delivery. Provides advanced solutions for healthcare and pharmaceutical products through particle engineering. Also offers contract analysis services for particle characterization. FDA registered (FEI for ANALYSIS operations). Active in European nanopharmaceutical development consortia (PHOENIX-OITB).

Navin Molecular (Navin Fluorine CDMO)

India

CDMO division of Navin Fluorine International Limited, one of India's leading fluorochemical companies. Specializes in custom synthesis and contract manufacturing of fluorinated APIs, advanced intermediates, and specialty chemicals for pharmaceutical companies. Leverages deep expertise in fluorine chemistry for complex molecule synthesis. Offers services from process development through commercial-scale manufacturing.

NCK A/S (Niels Clauson-Kaas)

Denmark

Danish CDMO founded in 1956 specializing in process development and API manufacturing for biotech and pharma companies taking new chemical entities (NCEs) from discovery to commercialization. Operates a multi-purpose GMP pilot plant with glass/glass-lined reactors (40-280L) including cryogenic capability (-80 degrees C). Services include process development, analytical development, reference samples, supply of API for toxicology and clinical studies, API release, ICH stability studies, and GMP documentation. QC lab equipped with HPLC (DAD/CAD), IC, GC-MS, and LC-MS/MS (QTOF).

Olon Ricerca Bioscience is a US-based CRO/CMO subsidiary of Olon SpA, specializing in chemical development and API manufacturing for preclinical and clinical phases. Founded in 1986 and acquired by Olon SpA in 2017, the company provides integrated services from synthetic chemistry and process development through to cGMP kilo-lab manufacturing at its Concord, Ohio facility.

Olon SpA is a global leader in the development and production of Active Pharmaceutical Ingredients (APIs) for CDMO and generic markets, integrating chemical synthesis and microbial biomanufacturing. The company operates 14 GMP facilities primarily in Italy, with additional sites in France (via GTP Bioways acquisition), the US, Germany, and China, with 450+ DMFs and 35+ years of regulatory experience.

Peptides International, founded in 1983, is a US-based custom peptide synthesis company now part of Biosynth's peptide division. The company operates from a 12,000 sq ft ISO 9001:2015 certified facility in Louisville, Kentucky, providing custom peptide synthesis and catalog peptide products. Previously merged with New England Peptide, the combined entity offers GMP peptide manufacturing capabilities as part of the broader Biosynth organization.

Praveen Laboratories Pvt Ltd is an Indian manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates for the pharmaceutical industry. Based in Surat, Gujarat, they export to 50+ countries. FDA-registered with FEI number 3005751252 for API manufacture and analysis. Listed on PharmaSource and CPHI Online as a leading API manufacturer with products including lamotrigine. They are not a contract CDMO but rather a dedicated API supplier.

Rodon Biologics is a Portuguese biotech CRO/CDMO with over 20 years of experience in biologics development and GMP manufacturing. The company specializes in recombinant protein production, antibody development, and biopharmaceutical product development for third parties. Rodon Biologics provides services from discovery research through GMP manufacturing of biopharmaceutical products.

Sinopep-Allsino Biopharmaceutical Co., Ltd. (Stock Code: 688076) is a Chinese innovation-driven company specializing in the development and manufacturing of peptide and oligonucleotide APIs and drug products. Listed on the Shanghai Stock Exchange, they operate as a full-service CDMO for complex peptide and oligonucleotide therapeutics. Their subsidiary Apextide Co., Ltd. is expanding with a large-scale manufacturing facility. The company has FDA-registered facilities with inspection history showing mostly compliant results.

USV Peptides is the peptide synthesis division of USV Private Limited, a 61-year-old Indian healthcare company originally founded as a joint venture with USV & P Inc. USA (Revlon subsidiary). They specialize in custom peptide synthesis and GMP-grade peptide manufacturing from their dedicated facility at Chiplun, Maharashtra. Capabilities include solid-phase and solution-phase peptide synthesis, peptidomimetics, conjugation, PEGylation, HPLC purification to >99% purity in multi-kg quantities, and full characterization (Mass, LC-MS, AAA, Ion Chromatography). They serve pharmaceutical, research, and cosmetic peptide markets globally.

Zach System is the chemical division of Zambon Company SpA, specializing in Active Pharmaceutical Ingredient (API) manufacturing, quality intermediates, and custom synthesis services for the pharmaceutical industry. Located in Avrille, France, with multipurpose equipment and reactors ranging from 50L to 10,000L.

Advanced Analytical Testing Laboratories (AATL / AATS) is an FDA-registered contract testing laboratory located in New Jersey and Rancho Cucamonga, California. They provide analytical testing, method development and validation, stability studies, microbiology testing, and R&D services for pharmaceutical, nutraceutical, and dietary supplement products. They comply with cGMP, USP, and ISO 17025 standards.

Aliri Bioanalysis is a bioanalytical services company. No website content was available for detailed extraction, but the company name suggests contract research/bioanalytical testing services rather than drug manufacturing.

Coriolis Pharma is a Germany-based contract research and development organization (CRDO) specializing in biopharmaceutical drug product development, analytical services, and formulation for liquid and lyophilized biologics. The company is headquartered in Martinsried near Munich with a new campus and a $10M R&D laboratory in Morrisville, North Carolina.

Coriolis Pharma Research GmbH is the legal entity of Coriolis Pharma, a global contract research and development organization (CRDO) headquartered in Martinsried, Germany. The company is the premier partner for drug product development, analytical services, and manufacturing services for biological therapeutics, with a focus on liquid and lyophilized drug products under both R&D and GMP conditions.

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.

F.I.S. (Fabbrica Italiana Sintetici) is a privately owned Italian CDMO operating since 1957, specializing in the development and production of APIs and cGMP intermediates for the global pharmaceutical industry. The company offers contract development and manufacturing services including HPAPI production up to OEB3 containment from multiple production plants.

Invivotek (InVivotek, LLC) is a preclinical CRO operating as part of Genesis Drug Discovery & Development (GD3), a fully integrated CRO supporting drug discovery from target discovery through IND filing and clinical trials. The company specializes in translational studies, in vivo pharmacology, disease modeling (with 150+ PDX models), PK/PD studies, and toxicology in an AAALAC-accredited facility.

Just - Evotec Biologics (wholly owned by Evotec) is a biologics CDMO specializing in monoclonal antibodies, next-generation biologics, and biosimilar products. Differentiated by proprietary integrated end-to-end continuous manufacturing platform (J.POD) which uses perfusion cell culture with continuous purification, achieving higher output in smaller footprint than traditional batch manufacturing. Two manufacturing sites in Seattle and Redmond, WA. Offers cell line development, analytical services, process development, and early clinical through commercial cGMP manufacturing. Uses AI/ML technologies in development.

KCAS Bio

Australia

KCAS Bio is a leading bioanalytical contract research organization (CRO) with 45+ years of experience. Supported 315+ approved drugs on market, developed 6,200+ assays. Services include bioanalytical development, biomarker analysis, immunogenicity testing, cellular and molecular assays, clinical kitting and sample management. Specializes in advanced modalities (cell therapy, gene therapy). Globally harmonized Cytek spectral flow cytometry across US, EU, and Australia sites. 20+ FDA audits with no major findings.

Lyophilization Technology, Inc. (LTI)

United States

Lyophilization Technology, Inc. (LTI) is a US-based CDMO focused on lyophilization (freeze-drying) development and sterile clinical supply manufacturing. They offer development sciences (formulation development, thermal analysis, cycle design, product characterization, pilot plant scale-up), clinical manufacturing (Phase I, II, and toxicology), and technical services. They have specialized capabilities in dual chamber cartridges and syringes, and isolation/containment for potent compounds.

Macsen Laboratories

India

Macsen Laboratories (N.K Agrawal Group), a chemical manufacturing organization with origins dating back to 1952, manufactures niche Active Pharmaceutical Ingredients, pharmaceutical application dyes, and specialty chemicals. They are the world's only cGMP manufacturer of a complete range of pharma application and injectable dyes. They specialize in cGMP manufacturing of niche, atypical, and rare-to-find APIs and also offer custom synthesis/contract research services. FDA-registered with FEI for API manufacturing. They are building a new API manufacturing facility to expand CDMO capabilities.

Mycenax Biotech is a Taiwan-based biologics CDMO specializing in the development and manufacturing of biosimilars, monoclonal antibodies, bispecific antibodies, ADCs, and cell & gene therapy-related products. The company provides integrated services spanning cell line development, process development, analytical services, GMP manufacturing, and regulatory support for global biotech and pharmaceutical partners. With expertise in mammalian cell culture and biologics manufacturing, Mycenax supports clients from early-stage development through commercial-scale production. The company has established GMP facilities in Taiwan and focuses on delivering flexible, high-quality manufacturing solutions for complex biologics and next-generation therapeutics.

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.

PPD, now part of Thermo Fisher Scientific, is one of the world's largest contract research organizations (CROs). While the URL references 'integrated CRO and CDMO solutions' under the Thermo Fisher umbrella (Accelerator Drug Development program combining Patheon CDMO and PPD CRO), PPD itself is fundamentally a CRO providing clinical research services: clinical trial management, laboratory services, biostatistics, regulatory affairs, and pharmacovigilance. The CDMO capabilities belong to Thermo Fisher's Patheon division, not PPD. PPD as a standalone entity is a CRO.

Selvita is a Poland-based integrated drug discovery and development service provider (CRO) with expanding CDMO capabilities following its 2024 acquisition of PozLab. The company offers comprehensive services spanning drug discovery (medicinal chemistry, pharmacology, DMPK, protein sciences), drug development (analytical, formulation, clinical trial batch manufacturing), and contract testing under GMP/GLP. Selvita has operations in Krakow, Poznan, and Wroclaw (Poland) and Zagreb (Croatia).

Triclinic Labs is a US-based contract research organization specializing in solid-state chemical development and materials characterization. Founded in 2009, they are an FDA-registered and inspected laboratory (2024) with a DEA Controlled Substance License (Class I-V). They provide physical and analytical chemistry services including solid-form screening, polymorph analysis, and intellectual property support. They do NOT manufacture drugs.

Juzen Chemical (Japanese: ten-zen kagaku) is a Japanese CDMO/CMC company specializing in active pharmaceutical ingredient and intermediate manufacturing. GMP-compliant quality standards with diverse synthesis technologies. Offers both small molecule and oligonucleotide API synthesis/manufacturing. Toyama-based manufacturing. This is the Japanese-language entry for the same company as Juzen Chemical Corp (English site). FDA registered with 1 FEI number for API manufacture.

Juzen Chemical Corporation (English name for the same entity as Juzen Chemical) is a Japanese CDMO providing contract manufacturing of APIs and intermediates plus CMC solution services. GMP-compliant with diverse synthesis technologies. Offers oligonucleotide pharmaceutical services (synthesis, development, GMP manufacturing) and small molecule contract manufacturing. Multiple manufacturing plants (JPP-I, JPP-II, JPP-III, JHP) and pilot plant. FDA registered with 2 FEI numbers, 7 inspections (3 NAI, 4 VAI, 0 OAI).

LucasPye BIO (LPB) is a US-based CDMO focused on accelerating biotherapeutic innovation. They offer comprehensive biopharmaceutical development and manufacturing solutions including cell line development, upstream/downstream process development, and cGMP manufacturing of biologics. They aim to bring down CDMO costs through strategic vendor partnerships to make biotherapeutics more affordable.

Luina Bio, now rebranded as AcuraBio after acquisition by Dr. Glenn Haifer and Ampersand Capital Partners, is an Australian-origin biologics CDMO. They specialize in plasmid DNA CDMO services and have expanded cGMP capabilities using Cytiva purification technology to support mRNA and cell & gene therapies. Merged with RoslinCT to create a combined cell therapy CDMO.

Louston International Inc. is a technology-driven organization with facilities in Philadelphia (USA), Beijing, Tianjin, and Shijiazhuang (China). They specialize in developing, manufacturing, and marketing fine chemical intermediates and APIs through two commercial sites in China. FDA-registered with FEI for API manufacturing and analysis.