Analytical Services CDMOs

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.

Jubilant Ingrevia Ltd

India

Jubilant Ingrevia is a global leader in life science ingredients and specialty chemicals, listed as a Jubilant Bhartia Group company. Core businesses: specialty chemicals (pyridine, picolines, fine chemicals, agrochemicals), nutrition & health solutions, and chemical intermediates (acetyls, specialty ethanol). They have a CDMO division (currently non-GMP per investor presentation) for custom synthesis and contract manufacturing of intermediates and fine chemicals. Website explicitly mentions CDMO services but the CRISIL report notes it is 'CDMO (Non-GMP)'. Primarily a chemical intermediates and ingredients manufacturer with a nascent pharma CDMO arm.

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.

Lucent Biotech Limited

India

Lucent Biotech Limited is an Indian third-party pharmaceutical manufacturer founded in 2006 in Roorkee (Haridwar). They manufacture a wide spectrum of pharmaceutical formulations and serve as suppliers for multiple Indian and multinational pharmaceutical companies. They are a contract manufacturer (third-party manufacturer) of pharmaceutical finished dosage forms.

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.

Manac Incorporated is a Japanese chemical manufacturer established in 1948, recognized as the top manufacturer of bromine and iodine compounds in Japan. The company supplies pharmaceutical intermediates and fine chemicals to the pharma industry, exhibiting at CPHI and Chemspec trade shows. Manac provides chemical building blocks used in API synthesis but does not itself manufacture pharmaceutical APIs or finished drug products on a contract basis.

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.

Prayog Life Sciences (also referred to as NSJ Prayog Life Sciences Pvt Ltd) is an Indian company established in 2018, listed on PharmaSource as providing contract manufacturing (CMO/CDMO), packaging, formulation development, process development, and analytical services. On CPHI Online they describe providing services for process optimisation and development of APIs along with their intermediates. Limited web presence with no website content available.

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.