Stability Studies CDMOs

NorthX Biologics

Sweden

NorthX Biologics is a Swedish CDMO specializing in advanced biologics and ATMPs (Advanced Therapy Medicinal Products). The company offers end-to-end services from process development to GMP manufacturing for recombinant proteins, viral vectors, plasmid DNA, cell therapy, extracellular vesicles, and mRNA. Recognized by the Swedish Government as an international competence center and innovation hub in 2021, NorthX has 30+ years of GMP manufacturing experience.

Ofichem Group

Netherlands

Ofichem Group is a family-owned European CDMO and pharmaceutical supplier founded in 1975, headquartered in Ter Apel, Netherlands. The company provides end-to-end services from drug substance (API) development through finished drug product manufacturing, including sourcing and distribution. Ofichem has recently expanded through acquisitions of Meribel Pharma Solutions' Uppsala site (early-phase development, ADCs, oligonucleotides, PROTACs) and Avivia (formulation development).

O.F.I. Officina Farmaceutica Italiana

Italy

O.F.I. Officina Farmaceutica Italiana is an Italian contract development and manufacturing company established in 1946, specializing in food supplements, medical devices, and dermo-cosmetic products. The company provides full-service contract manufacturing from idea generation to production, with capabilities in tablets, capsules, creams, gels, probiotics, and sterile processes. OFI holds ISO certifications including ISO 13485 (medical devices) and is FDA approved and Halal certified.

OneSource Specialty Pharma Limited

India

OneSource Specialty Pharma Limited (formerly Stelis Biopharma Limited) is India's first specialty pharma pure-play CDMO, offering multimodal end-to-end capabilities across drug-device combinations, complex sterile injectables, biologics, and soft gelatin capsules. The company operates five state-of-the-art facilities in Bengaluru with 35 approved ANDAs and 19 commercialized drug products in the US market.

Orchev Pharma Pvt Ltd

India

Orchev Pharma Pvt. Ltd., established in 1989 in Gujarat, India, is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates specializing in Ranitidine HCl, Famotidine, Telmisartan, and Levetiracetam. The facility is US-FDA, EU-GMP (AEMPS), WHO-GMP, KFDA, and COFEPRIS certified. USFDA inspection in 2018 was cleared with zero 483 observations.

Oxford Biomedica (OXB)

United Kingdom

Oxford Biomedica (OXB) is a global, quality- and innovation-led CDMO specializing in viral vector development and manufacturing for cell and gene therapy. With 25+ years of experience, OXB is the first and currently only FDA-approved CDMO for commercial production of lentiviral vectors for CAR-T therapy. The company operates GMP suites across three countries with extensive end-to-end capabilities in lentivirus, AAV, and adenovirus vectors.

Pagari PharmaTech, INC.

India

Pagari PharmaTech, INC. is a U.S.-based CDMO offering concept-to-commercialization services including Research and Development, Analytical Services, Technology Transfer, and Manufacturing Services for Solid and Liquid Oral Dosage Forms as well as OTC and Prescription (Rx) Drug Products. The company adheres to FDA, EMA, and ICH guidelines with support for IND, NDA, ANDA, and 505(b)(2) submissions. Small company (2-10 employees per LinkedIn), based in India with U.S. manufacturing services.

piCHEM (The Peptide Company)

Austria

piCHEM is a privately owned Austrian company with over three decades of experience in the manufacturing of synthetic peptides and peptide-related molecules. Provides full GMP service for peptides used as active pharmaceutical ingredients (APIs), including process scale-up, process validation, analytical services, stability studies, and regulatory support. Also manufactures peptide precursors for radiopharmaceuticals/nuclear medicine. Offers aseptic fill & finish services in-house or through qualified partners. EU-GMP/cGMP certified, FDA registered for API manufacture.

Quality Chemical Laboratories (QCL)

United States

Quality Chemical Laboratories (QCL) is a US-based CDMO located in Wilmington, North Carolina, specializing in comprehensive analytical testing, formulation development, and GMP clinical manufacturing. The company offers API synthesis, method development, taste masking, enteric coating, tablet film coating, and controlled/immediate release formulation development. QCL is FDA-registered for analysis, API manufacture, drug product manufacturing, and packaging.

Quotient Sciences

United Kingdom

Quotient Sciences is a UK-headquartered pharmaceutical CRDMO (contract research, development, and manufacturing organization) specializing in small molecule and synthetic peptide drug product development and manufacturing. They offer integrated formulation development, clinical manufacturing, and commercial production, with their proprietary Translational Pharmaceutics approach integrating clinical activities with real-time cGMP manufacturing. They have facilities in the US and UK, with capabilities including HPAPI manufacturing, sterile fill/finish, and oral solid dose.

Recipharm AB

Sweden

Rechon Life Science AB is a subsidiary/entity within the Recipharm group, the global CDMO headquartered in Stockholm, Sweden. This entry represents the same Recipharm organization (same website: recipharm.com) with its extensive global manufacturing footprint of 15+ FDA-registered FEI numbers and 52 FDA inspections. The Perplexity research confirms Recipharm's specialization in oral solid dose, inhalation, sterile manufacturing, and HPAPI capabilities. Rechon may represent a specific Recipharm site or legacy entity. Duplicate of Recipharm AB entry -- capabilities are identical.

Renejix Pharma Solutions

United States

Renejix Pharma Solutions (operating as HyCON Labs) is a US-based CDMO specializing in small molecule oral dosage form development and multi-modality manufacturing. The company offers end-to-end services from preformulation through commercial manufacturing, with 14+ technologies, 300+ pieces of equipment, 350+ employees, and 2+ facilities. They serve as a single-partner CDMO across all development stages.

Rezon Bio

Poland

Rezon Bio is a European biologics CDMO headquartered in Poland, specializing in mammalian drug substance development and GMP manufacturing. The company operates two FDA-approved facilities with mirrored capabilities, employs approximately 1,300 people (10% PhDs), and has 16 years of biologics development experience. Rezon Bio offers end-to-end services from cell line development through commercial manufacturing with 2,000L bioreactors.

Scientific Protein Laboratories (SPL)

United States

Scientific Protein Laboratories (SPL) is a CDMO specializing in cGMP biopharmaceutical manufacturing of APIs from biological sources, with over 30 years of experience. Core products include heparin derivatives (Heparin Sodium USP) and pancreatic enzymes (Pancreatin USP, Pancrelipase USP). The company also provides custom development services including fermentation, natural product extractions, and recovery/purification of therapeutic proteins from preclinical through commercial scale.

SCN BestCo

United States

SCN BestCo is a contract manufacturer of innovative pharmaceutical dosage forms for OTC drugs, vitamins, and dietary supplements. It specializes in gummy, soft chew, coated chew, and lozenge dosage forms and operates as a contract manufacturer of consumer healthcare products since 1976.

Senn Chemicals AG

Switzerland

Senn Chemicals AG is a Swiss CDMO specializing in peptide APIs, peptide fragments, amino acid derivatives, and small molecules. Founded in 1963 in Dielsdorf near Zurich, the company provides cGMP custom manufacturing services from early research to commercial phase. Senn Chemicals has been inspected multiple times by the US FDA and was acquired by Granules India in 2025 to expand peptide therapeutics and CDMO capabilities.

Serán BioScience

United States

Seran BioScience is a US-based CDMO headquartered in Bend, Oregon, recognized as a world leader in drug delivery and formulation development. The company provides comprehensive drug development and clinical/commercial manufacturing services, specializing in spray drying and particle engineering, preformulation, dosage form development, and cGMP manufacturing. Seran recently secured $200M+ from Bain Capital to build a new 100,000 sqft commercial manufacturing facility for non-sterile oral solid dose pharmaceuticals.

SERATEC

Germany

SERATEC is a French-German CDMO specializing in the development and production of active pharmaceutical ingredients (APIs) for rare and orphan diseases as well as high-value small molecules. Founded in 1970, the company provides end-to-end API solutions from molecule design through development, registration with leading regulatory agencies, and cGMP commercial production. SERATEC is FDA-registered and has been FDA-inspected for API manufacturing.

SGS

Brazil

SGS Integrated CDMO Solutions is the contract development and manufacturing division of the global testing and inspection company SGS SA. Established in 2002 with a specialized UK-based CDMO site (MHRA and FDA inspected), SGS provides formulation development, API manufacturing, sterile fill/finish, lyophilization, and analytical services. A new 55,000 sq ft cGMP facility in Hudson, NH expands their North American capabilities across Phase I-III clinical trials and commercial supply.

Sharp Sterile Manufacturing

United States

Berkshire Sterile Manufacturing (now Sharp Sterile Manufacturing, acquired by Sharp in 2023) is a specialist CDMO providing sterile injectable development and manufacturing services from its isolator-based facility in Lee, Massachusetts. All fills are 100% isolator-based using Colanar fillers, supporting clinical through small-to-mid-scale commercial production of vials, syringes, and cartridges. FDA-inspected with 8 inspections (7 NAI, 1 VAI), demonstrating strong regulatory compliance.

SIDEFARMA

Portugal

SIDEFARMA is a Portuguese CMO with over 45 years of experience, specialized in the manufacture of small and medium-size batches of solid dosage forms (coated tablets, tablets, capsules), semi-solids (creams, gels, ointments), and liquid pharmaceuticals. The company provides contract manufacturing, contract packaging, and contract development services following European quality standards, while also commercializing its own branded pharmaceutical products.

Siegfried Group

China

Siegfried Group is a leading global CDMO with 150+ years of pharmaceutical and chemical heritage, operating 13 production sites across Switzerland, Germany, Spain, France, Malta, the USA, and China. The company provides integrated services from early-phase API development through commercial-scale drug substance and drug product manufacturing, including exclusive synthesis, generic APIs, controlled substances, HPAPI handling, sterile formulations, and viral vector manufacturing through subsidiary DINAMIQS. In January 2026, Siegfried announced acquisition of additional US-based small molecule drug substance capacity.

SmaBio Labs

United States

SmaBio Labs is a USA-based CDMO located in Research Triangle Park, North Carolina, delivering end-to-end drug development solutions from molecule discovery to market launch. They specialize in Chemistry Manufacturing and Control (CMC) services for small molecules, peptides, biologics, and complex APIs. Their capabilities include analytical services (IND/ANDA support, method development and validation, ICH stability testing, HPLC/UPLC, LC-MS, ICP-MS, NMR, XRPD), drug discovery and process development, API manufacturing (kg-scale cGMP), product development (formulation for oral solid dose, injectables, lyophilized products), and clinical trial material manufacturing (Phase I-III). FDA registered for analytical services. They support HPAPI compounds up to OEB 5.

STC Biologics

United States

STC Biologics, Inc. is a boutique turn-key biologics CDMO located in Newton, Massachusetts, USA, founded in 2009. The company provides full CMC services and consulting to enable partners to advance biologic products from discovery to commercialization. Their team brings expertise from Genentech, Novartis, Shire, EMD Serono, Lonza, Alexion, and Merrimack. STC offers a Speed-To-Clinic Platform for monoclonal antibodies that can go from royalty-free cell line development directly to cGMP manufacturing and released drug substance within 12 months. They opened a single-use mammalian GMP facility in 2019 and have filed 8+ BLAs, dozens of INDs, and 20+ comparability protocols. They also developed their own biosimilar product, STC101.

Sterling Pharma Solutions

Ireland

Sterling Pharma Solutions is a global CDMO with over 50 years of experience providing API development and manufacturing services to pharmaceutical and biotech companies. The company specializes in high potency APIs, hazardous chemistry, controlled substances, peptides, flow chemistry, biocatalysis, and ADC bioconjugation across six facilities in the UK, Ireland, and US.

SuanFarma

Italy

SuanFarma is an Italian-headquartered CDMO providing comprehensive API and intermediate manufacturing services combining fermentation, purification, and chemical synthesis. The company operates GMP facilities in Europe (Italy and Portugal) with over 2,000 m3 fermentation capacity and 800 m3 reaction capacity, serving 400+ customers in 70+ countries.

Symphony Pharma Life Sciences Pvt Ltd

India

Symphony Pharma Life Sciences is a CRO and CDMO based in Hyderabad, India, founded in 2008 by research-driven scientists. The company operates a 25,000+ sq. ft. research facility in Genome Valley, providing contract research, custom synthesis, and contract development and manufacturing services. Symphony has executed 40+ NCE intermediate projects for global innovator companies, developed 8 new APIs (including Lacosamide with USFDA-approved DMF), and synthesized 250+ API impurities for global MNCs.

Tedor Pharma Inc

United States

Tedor Pharma is a US-based CDMO with 20+ years of experience specializing in solid oral dosage forms. Located in Cumberland, Rhode Island, they provide end-to-end outsourcing from IND/NDA/ANDA through commercial manufacture. Services include formulation development, clinical trial manufacturing (including placebo), commercial GMP manufacturing at various scales, analytical services (characterization, testing, development, QA), and clinical supply chain management. FDA-registered and inspected (5 inspections, all VAI), DEA-licensed for controlled substances Schedules II-V. They have 2 FDA-approved products (tablets, oral route). The company announced a recapitalization and new management.

Tekro Lab

Czechia

Czech pharmaceutical CRO and CDMO specializing in veterinary pharmaceuticals and animal health. Offers GMP-certified contract manufacturing of solid dosage forms (premixes, pellets, tablets) with various active substances including penicillins, tetracyclines, and potentiated sulphonamides. Also provides contract research (preclinical studies), pharmacovigilance services, and regulatory affairs for veterinary medicinal products. Over 30 years of experience in the pharma industry.

UniD Manufacturing

Belgium

UniD Manufacturing is a Belgian CDMO fully dedicated to polymer-based long-acting formulations for sustained release and local delivery of drugs. They offer end-to-end services from proof of concept to commercialization, specializing in non-biodegradable (up to 9 years release), biodegradable (3-18 months), and resorbable (1 day to 3 months) polymer technology platforms. Applications include vaginal rings, ophthalmic implants, inserts, and other implantable dosage forms. They have 20+ years of expertise and GMP-approved cleanrooms accredited for multi-product manufacturing, with required facilities for high-potent APIs (hormones, peptides).

Valpharma Group

San Marino

Valpharma Group is a pharmaceutical and nutraceutical CDMO based in San Marino with 40+ years of experience. The group consists of Valpharma San Marino S.p.A. and Valpharma International S.p.A. (two CDMO pharmaceutical companies) plus Erba Vita Group S.p.A. (nutraceuticals). They specialize in modified-release products in capsules and tablets, including narcotic and psychotropic substances. Services include contract manufacturing, tech transfer, regulatory and e-CTD management, pharmaceutical development, stability studies, and IMP (investigational medicinal product) batch production. They operate three production plants and are routinely audited by Italian Health Authorities for GMP compliance. Products sold in 70+ countries.

Vianex S.A.

Greece

Vianex S.A. is a prominent Greek pharmaceutical company listed on PharmaSource as a CDMO. The company is described as specializing in contract development and manufacturing. While the website content is primarily in Greek and could not be fully parsed, PharmaSource confirms CDMO services. The company appears to have multiple manufacturing facilities (Factory A, B, C, D mentioned in navigation) and covers a broad range of dosage forms. Founded by Paul J. Giannacopoulos.

Vihita Chem (P) Ltd

India

Vihita Chem Private Limited is an Indian API and intermediates manufacturer established in 1990 in Ankleshwar, Gujarat. The company manufactures APIs (Donepezil, Valsartan, Losartan, Atorvastatin, Pinaverium Bromide), API intermediates, fragrance intermediates, specialty chemicals, and customized products. Three manufacturing facilities in Ankleshwar GIDC, with additional land acquired at Dahej and Jhagadia for Units 3 and 4. ISO 9001:2015, ISO 14001:2015, ISO 45001:2018 certified. FEI number 3004562353. R&D recognized by DSIR, Ministry of Science and Technology, Government of India. 200+ employees, 100+ products. Building EU-GMP facility in Unit-2.

Xedev

Belgium

Xedev is a flexible CDMO based in Belgium, specialized in formulation and process development for oral solid dosage forms. They offer early-phase development services including spray drying, hot melt extrusion, amorphous solid dispersions, and GMP clinical manufacturing for Phase I and Phase II batches.

3PBiovian

Finland

3P Biovian is a global biologics CDMO providing end-to-end services from early-stage development to commercialization. They specialize in proteins, viral vectors, plasmid DNA, and cell therapy products with cGMP manufacturing facilities in Turku, Finland, and Pamplona-Noain, Spain. The company has invested over 50 million euros in facility expansion.

53 Biologics

Spain

53 Biologics is a Spanish CDMO specializing in biologics production from plasmid DNA to proteins. They provide services from preclinical development to cGMP manufacturing, with over 4,500 sqm of facilities including microbial and mammalian manufacturing lines. They hold ISO 9001, ISO 13485, ISO 14001 certifications and operate under GMP.

ABC Farmaceutici, an ICE Pharma company, is an Italian CDMO established in 1925 specializing in oral solid and liquid formulation manufacturing. Their 76,000 sqm facility in Ivrea (near Turin) is fully GMP certified and regularly inspected by AIFA and FDA. As part of ICE Pharma, they manage the entire drug supply chain from API through finished dosage form manufacturing.

Advaxia Biologics is a CDMO near Rome, Italy, specializing in adenovirus vaccine development and cGMP manufacturing. With over 10 years of biologics expertise and a 100% batch approval rate, Advaxia provides fully integrated services from expression systems and process development to analytical development and GMP manufacturing, and is EMA, FDA, and AIFA compliant.

Amapharm Group

Germany

Amapharm Group is a contract manufacturer specializing in gummy vitamins, jelly beans, chews, and innovative dosage forms for dietary supplements and nutraceuticals. Founded in 1977, the company pioneered the world's first vitamin gummy in 1996. They manufacture custom formulations for private label clients but do not manufacture pharmaceutical drugs.

AMPAC Analytical is part of SK pharmteco, a major integrated CDMO providing custom small molecule API development and manufacturing, viral vector and gene therapy CDMO services, and comprehensive analytical testing. SK pharmteco operates FDA/EMA/PMDA-inspected facilities across the US, Korea, Ireland, and France with capabilities spanning from clinical trials through commercial scale manufacturing.

AMSA S.p.A. (CFM Group)

Italy

AMSA S.p.A. is part of CFM Group, a custom API synthesis and contract manufacturing organization with three production plants in Italy and Ireland. The group specializes in small-medium volume API manufacturing for both generics and custom synthesis, operating under full cGMP compliance with a strong FDA inspection track record.

Archimica S.p.A.

Italy

Archimica S.p.A. is an Italian CDMO specializing in active pharmaceutical ingredients (APIs) and advanced intermediates. Based in Lodi, Italy, they are known for experience with the most challenging reagents, reactions, and substance classes in chemical synthesis. The company was acquired by PI Health Sciences in 2023. They hold FDA registration with operations in analysis and API manufacture, and have a strong track record of CEP/DMF filings for their products.

Arevipharma GmbH

Germany

Arevipharma GmbH is a German CDMO based in Radebeul with nearly 150 years of corporate history in synthetic API manufacturing. They produce active pharmaceutical ingredients from gram scale up to several hundred tons per year under cGMP standards across five production scales. They serve small, medium, and large pharmaceutical customers worldwide with API manufacturing, registration, and marketing services. They are FDA-registered for API manufacture.

Arran Chemical Company (Almac Group)

Ireland

Arran Chemical Company, now part of the Almac Group, is an Irish chemical manufacturer with over 40 years of experience specializing in custom synthesis of pharmaceutical intermediates, APIs, and registered starting materials (RSMs). Based in Athlone, Ireland, they offer specialized reaction technology including organometallic synthesis, catalytic transfer hydrogenation, and biocatalysis/chemocatalysis capabilities from kilo lab/pilot plant (10L to 1400L) through multi-tonne commercial scale.

Arxada (CDMO)

Australia

Arxada (formerly part of Lonza Specialty Ingredients) is a CDMO with over 40 years of experience in custom development and manufacturing of advanced intermediates and active ingredients. They operate from sites in Visp (Switzerland) and Kourim (Czech Republic), offering both chemical synthesis and biotechnology/fermentation routes from gram to multi-metric-ton commercial scale. Their backward-integrated site with on-site waste and energy management provides a comprehensive CDMO offering spanning process development, analytical development, formulation, and regulatory support.

BBT Biotech GmbH

Germany

BBT Biotech GmbH is a German CDMO specializing in pharmaceutical active ingredients of biological origin. Based in Baesweiler near Aachen, they focus on fermentation (upstream processing) and protein purification (downstream processing) for the development, manufacture, and international distribution of biopharmaceuticals. They have had 1 FDA inspection with an OAI outcome.

BianoScience GmbH

Germany

BianoScience GmbH (rebranded to XNApharma GmbH in 2024) is a specialist CDMO focused on oligonucleotide synthesis and manufacturing, from R&D scale through GMP production. Based in Gera, Germany, the company provides custom oligonucleotide synthesis, modifications, analytics, and large-scale/GMP oligonucleotide manufacturing for clinical and commercial use.

Bionex Pharmaceuticals LLC is a US-based pharmaceutical development CRMO (Contract Research and Manufacturing Organization) specializing in novel topical, transdermal/transmucosal, and implant drug delivery systems. They offer pre-formulation through clinical supply manufacturing, with many R&D projects funded by NIH and NSF grants. Located at the New Jersey Bioscience Center. They have had 3 FDA recalls (1 Class I, 2 Class II).