Regulatory Support CDMOs

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.

RNP Pharmachem is an Indian pharmaceutical company providing CDMO/CMO services and site transfer project activities. The company operates a Singapore EU-GMP approved manufacturing facility and has 51-200 employees. Limited information is available about the company's specific capabilities and therapeutic focus beyond its general CDMO/CMO service offering.

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.

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.

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.

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.

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.

Mithra Biotechnology Inc. is Taiwan's first Contract Research Organization (CRO), established in 1988. The company offers integrated multi-dimensional CRO services including biologics analysis, biospecimen analysis, regulatory strategy and consultation, early clinical trials, drug analysis services, and subject recruitment. FDA-registered for analysis operations with 1 FDA inspection (VAI).

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.

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.