Stability Studies CDMOs

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.

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.

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.

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.

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.

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.

Raybow PharmaScience

China

Raybow PharmaScience (Raybow USA), a subsidiary of Jiuzhou Pharma, is a chemical CDMO specializing in custom synthesis, process development, analytical services, and cGMP production for small molecule APIs, specialty chemicals, and polymers. They offer services from benchtop R&D to commercial-scale production with facilities in North America, Europe, and Asia. FDA-registered for API manufacture and analysis.

Regis Custom Pharma (Regis Technologies, Inc.)

United States

Regis Technologies (now part of ESTEVE CDMO/Esteve Quimica) is a US-based API CDMO specializing in small molecule custom API synthesis, process development, analytical development, and cGMP manufacturing. They combine expertise in organic synthesis with chromatography separations (including chiral separations) to provide customized solutions from discovery to commercial delivery. They also manufacture chromatography products. FDA-registered for API manufacture with clean inspection history.

Seda Pharma Development Services Ltd

United Kingdom

Seda Pharma Development Services Ltd is a UK-based pharmaceutical development consultancy and clinical manufacturing services provider. Through its subsidiary Seda Clinical Manufacturing Services (MHRA-licensed), the company provides formulation development, clinical pharmacology, DMPK, modelling, and GMP manufacturing of clinical trial materials. The company focuses on product design, performance prediction, and clinical supply.

STA Pharmaceutical Co., Ltd. (WuXi STA) is a subsidiary of WuXi AppTec and one of the world's leading CDMOs, specializing in integrated CMC services for small molecule APIs and drug products (oral and injectable/sterile) from preclinical to commercial scale. They also have capabilities in oligonucleotides, peptides, and bioconjugates. WuXi STA operates 9-14 global manufacturing sites across Asia, North America, and Europe with uniform quality/EHS standards approved by major regulators. They have supported 50+ first-time drug approvals since 2017 across 105 countries. The company has 5,100+ scientists, claims 100% PPQ success rate, and serves 1,200+ customers. Their Changzhou site has passed US FDA inspection and they have a continuous manufacturing line for oral solid dose.

Stason Pharmaceuticals, Inc. is a US-based pharmaceutical company headquartered in Irvine, California, with CDMO services provided through its affiliate Western PharmSci. The company operates in both branded/generic pharmaceuticals and contract services. Their CDMO capabilities include turn-key drug development and manufacturing for oral solid dosage forms with particular expertise in high containment products (OEL down to 0.1 ug/m3) for oncology, CNS, and other potent compounds. Services span from pre-formulation characterization and API synthesis through commercial production (up to 600 kg), including analytical method development/validation, formulation development, clinical trial materials, and serialization. They hold 30+ ANDAs and have operations in 13 locations across 9 countries. Note: FDA issued a warning letter on July 8, 2020, citing significant CGMP violations for finished pharmaceuticals.

ST Pharm is a South Korean global API CDMO company founded in 1983, specializing in small molecule APIs, oligonucleotide therapeutics (ASO, siRNA, aptamers), and mRNA-LNP manufacturing. The company operates cGMP manufacturing facilities in South Korea and has a CRO subsidiary (AnaPath) in Switzerland and Spain for preclinical pathology services.

Sunny Pharmtech Inc. is a Taiwan-headquartered integrated specialty pharmaceutical CDMO specializing in high-potency APIs and drugs, including small molecules, peptides, and ADC linker-payloads. The company develops complex, high-barrier, niche drugs including ANDAs and 505(b)(2) filings, with state-of-the-art facilities offering OEB 5 containment and capabilities from early-stage formulation development to commercial manufacturing.

Symbiotec Pharmalab is a leading Indian manufacturer of corticosteroid and steroidal-hormone APIs with a global leadership position. With over 30 years of experience, the company has evolved from lab-scale manufacturing to industrial-scale production, operating two FDA-approved facilities (Rau and Pithampur, Indore). The company offers integrated CDMO solutions across organic chemistry, biotechnology/fermentation, and complex injectable platforms. It holds a 50%+ global market share in key steroid API molecules and serves 200+ customers in 40+ countries.

TBD Pharmatech

Estonia

TBD Pharmatech (formerly TBD-Biodiscovery) is an EU-based small-molecule API CDMO headquartered in Tartu, Estonia. They are a dual-site, EU-GMP-certified organization specializing in small-molecule API development and niche-to-mid-volume commercial manufacturing. Services include end-to-end CDMO (route scouting to commercial supply), technology transfer, clinical and commercial batch production under cGMP, analytical method development, QP (Qualified Person) release, CMC regulatory support, and API distribution/sourcing under GDP. EU-GMP certified since 2008, ISO 9001 certified, FDA-registered for API manufacture and analysis. They operate two GMP facilities (Tiigi and Valja sites) in Tartu.

Taiwanese CDMO specializing in transdermal drug delivery systems (TDDS), topical patches, and oral films. Over 30 years of experience in hydrogel patch, NSAID patch, and cosmetic patch development and manufacturing. Covers over 70% of OTC patches on the Taiwan market and exports to Asia, Europe, and North America. Also offers CMO and CRO services for transdermal patch development.

US-based topical and transdermal pharmaceutical CDMO, now merged with MedPharm (Durham, NC). Provides end-to-end services from formulation development through commercial manufacturing for topical, transmucosal, and transdermal drug products. Specializes in semi-solids, aerosols, liquids, injections, and transdermal patches. Offers in-vitro permeation testing (IVPT), in-vitro release testing (IVRT), disease activity models, tissue protein binding, and continuous flow technologies. GMP-certified manufacturing for generics, OTC, and prescription products.

Unither Pharmaceuticals is a global CDMO specializing in sterile and non-sterile liquid pharmaceutical forms, and the world leader in Blow-Fill-Seal (BFS) technology with annual production capacity exceeding 5 billion doses. Founded in 1993 in France, they operate 9 production sites across Europe, North America, South America, and China with 2,500+ employees. They offer contract manufacturing (clinical and commercial), formulation/analytical development, out-licensing of turnkey products, co-development partnerships, and regulatory support including CTD/eCTD submissions. Products include BFS single-doses, multi-doses, vials, sprays, stick packs, and ophthalmic solutions.

Velesco Pharma (Pace Life Sciences)

United States

Velesco Pharmaceutical Services, now part of Pace Life Sciences (acquired by Pace Analytical), is a U.S.-based pharmaceutical CDMO specializing in drug development services. Per search results and industry listings, they provide analytical drug development, drug formulation, and pharmaceutical CDMO services. The acquisition by Pace Life Sciences expanded their capabilities in drug development services. The website (velescopharma.com) was blocked by Cloudflare security at scrape time, so detailed capability information is limited. They are listed on PharmaSource and CMOCRO as a CDMO.

Duplicate entry for VGXI Inc (see companyId 58cac364). Same company -- leading plasmid DNA CDMO in Texas. Same website URL (vgxii.com). Same capabilities, facilities, and services.

Vibalogics is a specialized global CDMO for virotherapy manufacturing, now operating as Recipharm Advanced Bio after acquisition by Recipharm AB. The company offers process and analytical development, GMP manufacturing of viral vectors, oncolytic viruses, and advanced therapies. Capabilities include xRNA therapies, viral vectors (AAV, lentivirus), microbial/live biotherapeutic products, recombinant proteins, plasmid DNA, and lipid nanoparticles. Major $50M expansion of Cuxhaven facility (500L manufacturing line) completed. 118,000 sq ft GMP facility in Massachusetts (US) also completed.

360biolabs (a BioAgilytix company)

Australia

360biolabs, a BioAgilytix company, is Australia's most comprehensive bioanalytical laboratory offering pharmacokinetic, pharmacodynamic, immunogenicity, biomarker, and vaccine/infectious disease assay services. They support early-phase clinical studies with GLP-compliant testing across 6 global locations.

Accugen Laboratories, Inc.

United States

Accugen Laboratories is a contract microbiological quality control, research, and testing services laboratory based in Willowbrook, Illinois. They specialize in pharmaceutical microbiology testing, cosmetics and personal care microbiology testing, and environmental monitoring. Note: the website at accugen.com belongs to ACUGEN Software (a test generation software company), not Accugen Laboratories.

Anacura

Belgium

Anacura is a Belgian group of analytical service companies with 25+ years of experience in end-to-end analytical and laboratory services. The group includes AnaBioTec and Labo Nuytinck, plus OHMX.bio for multi-omics. Anacura provides analytical testing, quality control, and laboratory services for pharmaceutical and life science clients with FDA-registered operations.

ARL Bio Pharma

United States

ARL Bio Pharma is a U.S.-based contract testing laboratory headquartered in Oklahoma City, providing analytical and microbiological testing services for the pharmaceutical industry. They serve compounding pharmacies, outsourcing facilities, and pharmaceutical manufacturers with comprehensive laboratory quality testing including analytical testing, microbiology testing, raw material testing, forensics testing, and bioanalytical testing. They are FDA-registered for analytical operations.

Asha Pharma LLC

United States

Asha Pharma LLC is a contract research organization specializing in solid form screening, polymorph screening, salt screening, cocrystal screening, and crystallization process development. They focus on solid-state characterization and crystallization optimization for small molecule drugs, including DEA-scheduled substances. They do not manufacture drug product at commercial scale.

AZIDUS LABORATORIES LIMITED

India

Azidus Laboratories Limited is a full-service clinical research organization (CRO) based in Chennai, India, supporting the pharmaceutical and biotechnology industries. Their services include bioavailability/bioequivalence (BA/BE) studies, Phase I-IV clinical trials management, regulatory submissions (CTD preparation), bioanalytical services (LC-MS/MS), clinical data management, statistical analysis, pharmacovigilance, and medical writing. They maintain a volunteer pool of over 45,000 participants. Azidus adheres to GCP, GLP, and international regulatory standards across therapeutic areas including oncology, cardiology, nephrology, urology, and diabetology. They are a CRO, not a drug manufacturer.

Berko Pharmaceuticals is a Turkish pharmaceutical company involved in the development, manufacturing, and marketing of pharmaceutical products including solid dosage forms and suppositories. Listed on CPHI as a CDMO specializing in development and manufacturing, with FDA-registered facilities and a long track record of FDA-inspected production (2 NAI inspections). Also has 27 FDA recalls on record, indicating substantial US market supply history.

Bioneer A/S

Denmark

Bioneer A/S is a Danish not-for-profit Contract Research Organisation and subsidiary of the Technical University of Denmark (DTU). They specialize in in vitro modeling, drug formulation, and recombinant protein R&D services and manufacturing. While they offer CDMO services for recombinant protein production, their primary identity is as a CRO providing customized research services. Based in Horsholm, Denmark.

Biotrial

France

Biotrial is a leading full-service CRO (Contract Research Organization) founded in 1989, specializing in drug development with expertise in preclinical pharmacology, clinical development (Phase I with healthy volunteers and special populations), bioanalysis, biometrics, ECG, CNS, and imaging core lab. The company operates from locations in France, the US (Newark, NJ), and Canada (Laval, QC), performing hundreds of studies each year.

Charles River Laboratories

Australia

Charles River Laboratories is a global contract research organization (CRO) providing drug discovery, safety assessment, and preclinical services across the drug development lifecycle. The company recently divested its CDMO business, indicating it is focused on research services rather than contract manufacturing. It has extensive FDA-registered facilities worldwide.

Chongqing Carelife Pharmaceutical Co., Ltd. (Kailin Pharmaceutical) is a Chinese pharmaceutical company offering CDMO services for API manufacturing. The company has 2 FDA-registered facilities with 10 FDA inspections on record, producing APIs including clindamycin and amenamevir for domestic and international markets.

Conscio Group

Austria

Conscio Group is a European scientific service provider headquartered in Munich, Germany, offering laboratory services across pharmaceuticals, food, and environmental sustainability. The pharma division provides formulation development, analytical R&D, bioanalytical testing, clinical trials, IMP manufacturing, batch release testing, biologics and biosimilars testing, microbiology, and pharma analysis. Conscio operates GMP/GCP/GLP and FDA-certified laboratories in Germany, Czech Republic, Austria, and Slovakia.

Dawn Scientific Inc

United States

Dawn Scientific Inc is a US-based supplier of laboratory consumables, chemicals, reagents, and equipment for the pharmaceutical industry. The company sells ACS-grade chemicals, high-purity solvents, reference standards, and provides stability storage and CMC consulting services. Dawn Scientific is a distributor and supplier, not a contract drug manufacturer.

Doppel Farmaceutici

Italy

Doppel Farmaceutici Srl is an Italian CDMO operating since 1994, specializing in contract manufacturing and packaging of finished dosage forms for pharmaceutical companies. The company offers formulation development, R&D, manufacturing of soft and hard gelatin capsules, tablets, oral liquids, and semi-solids, along with full packaging services.

Dottikon Exclusive Synthesis AG

Switzerland

Dottikon Exclusive Synthesis AG is a Swiss CDMO that manufactures high-quality performance chemicals, intermediates, and exclusive active pharmaceutical ingredients (APIs) for the global chemical, biotech, and pharmaceutical industry. The company has over 110 years of experience in hazardous chemical reactions and operates an FDA and Swissmedic approved cGMP manufacturing site.

Formosa Laboratories is a Taiwan-based CDMO specializing in custom synthesis and contract manufacturing of active pharmaceutical ingredients (APIs) for the global pharmaceutical industry. The company provides services from process development through commercial-scale API manufacturing, with FDA-registered facilities.

FreeThink Technologies

United States

FreeThink Technologies is a U.S.-based contract research organization specializing in accelerated stability testing, shelf life prediction, formulation development, and analytical services for pharmaceutical compounds. The company develops ASAP prime software for stability modeling and provides integrated services from molecule to clinic for small molecule drug development.

Fuji Chemical Industries Co., Ltd. is a Japanese pharmaceutical company specializing in API synthesis, spray drying contract manufacturing, drug product manufacturing, and excipient production. Founded in 1946 in Toyama, the company has been an FDA-inspected API manufacturer since 1981, and holds proprietary spray drying technology as well as excipient brands including Neusilin, Fujicalin, and F-melt.

FUJIFILM Biotechnologies (formerly FUJIFILM Diosynth Biotechnologies) is a global biologics CDMO operating 10 facilities across the US, UK, Denmark, and Japan with over 4,800 employees. The company provides end-to-end cGMP manufacturing services for biologics, advanced therapies, and vaccines, from preclinical through commercialization, with $8.6 billion invested in recent years and 20+ commercial licenses.

Genetic S.P.A.

Italy

Genetic S.p.A. is an Italian pharmaceutical company dedicated to the research, development, manufacturing, and marketing of therapeutic solutions, including manufacturing on behalf of third parties. The company operates from facilities in Fisciano (Salerno) and Anagni (Frosinone), with liquids and oral solids manufacturing departments. Genetic is present in over 30 European and extra-EU countries and offers third-party manufacturing and out-licensing services.

Global Pharma CM S.A. (Poland)

Poland

Global Pharma CM S.A. is a Polish pharmaceutical contract manufacturing company. Limited information is available from the website, but search results reference it as a GMP manufacturing and pharmaceutical contract manufacturing organization based in Poland.