Regulatory Support CDMOs

With more than 30 years of CDMO experience, Ferndale Labs CDMO supports pharmaceutical and healthcare companies developing and manufacturing liquid and semi-solid drug products. Our FDA-registered facility specializes in semi-solid and liquid formulations, including creams, gels, lotions, ointments, suspensions and solutions for Rx, OTC, and medical device applications. Built on agility, flexibility, and versatility, Ferndale helps partners advance programs from development through clinical supply and commercial manufacturing.

BioSpring GmbH

Germany

BioSpring GmbH is a Frankfurt-based oligonucleotide CDMO and global leader in nucleic acid manufacturing and analysis since 1997. The company specializes in manufacturing mRNA, siRNA, guide RNA, ASO, and other oligonucleotides across all clinical phases to commercial scale. BioSpring has invested over 100 million euros in a new large-scale production facility for nucleic acid-based therapeutics.

ResolveMass Laboratories Inc. is a Canadian pharmaceutical CRO and CDMO providing analytical testing, characterization, and drug development support for pharmaceutical, biotechnology, and medical device companies worldwide. Our expertise spans small molecules, peptides, biologics, biosimilars, oligonucleotides, polymers, and complex drug products. We offer specialized services including mass spectrometry (LC-MS/MS, LC-HRMS), peptide characterization, impurity identification, nitrosamine analysis, extractables and leachables (E&L) studies, bioanalytical testing, stability studies, method development, and regulatory support. Our multidisciplinary scientific team helps clients address complex analytical challenges and generate high-quality data to support research, development, manufacturing, and regulatory submissions. ResolveMass Laboratories operates from Canada and serves clients across North America, Europe, and Asia. The company maintains an ISO 9001:2015 certified Quality Management System, is FDA-registered, and holds a Health Canada Drug Establishment Licence for GMP-compliant operations. We are committed to delivering scientifically rigorous, reliable, and timely solutions that accelerate drug development and support regulatory success.

Curapath

Spain

Curapath is a European CDMO specialized in polymer- and lipid-based non-viral drug delivery systems, supporting programs from preclinical through commercial manufacturing. The company has expertise in lipid nanoparticle (LNP) formulations, polymer excipients, and nanoparticle formulations for cell and gene therapy applications. Curapath operates manufacturing facilities in Valencia, Spain and has offices in Cambridge, Massachusetts.

Aarti Pharmalabs Limited

India

Aarti Pharmalabs Limited is a leading Indian small-molecule CDMO specializing in API and drug substance development and manufacturing. They operate six manufacturing plants with two R&D centers, accredited by USFDA, EU GMP, EDQM, and KFDA. They provide services from process R&D through stability studies, scale-up, process validation, and commercial manufacturing, including high-potent/cytotoxic molecules and flow chemistry.

AB Biotechnology Ltd

United Kingdom

AB Biotechnology Ltd is a UK-based biologics CDMO located at Pentlands Science Park near Edinburgh. They specialize in development and GMP manufacturing of high-purity biopharmaceutical products including proteins, peptides, and polyclonal antibodies. Their MHRA-licensed facility includes cleanroom suites for purification, viral inactivation/reduction, fill/finish, and lyophilization for injectables.

AbbVie Contract Manufacturing (AbbVie CMO)

Italy

AbbVie Contract Manufacturing is an embedded CMO within AbbVie, providing third-party contract manufacturing services for over 40 years across 12 locations in the US and Europe. They offer services spanning antibody drug conjugates, aseptic fill/finish, biologics (mAbs and derivatives), custom API, eye care, hot melt extrusion, HPAPI, and oral solid dose manufacturing.

Abiogen Pharma S.p.A.

Italy

Abiogen Pharma S.p.A. is an Italian pharmaceutical company established in 1997 with a century-long heritage, performing CMO and CDMO activities alongside its own product portfolio. They offer formulation development, analytical testing, scale-up, and commercial production from their cutting-edge manufacturing plant in Pisa. They specialize in bone metabolism, hypovitaminosis D, pain, dermatology, respiratory, and gastroenterology.

ABL (ABL, Inc. / ABL Europe)

France

ABL Inc. (also operating as Ascend Advanced Therapies - ABL Inc.) is a biologics CDMO focused on viral vector GMP manufacturing for gene therapies, vaccines, oncolytic viruses, and immunotherapies. They operate facilities in Rockville, MD (USA) and Strasbourg and Lyon (France), with 35+ years of experience. This is the same entity as ABL (ABL, Inc. / ABL Europe), appearing as a duplicate record in the database.

Abzena

United States

Abzena is a leading complex biologics and bioconjugates CDMO+CRO headquartered in the UK with 20+ years of experience. They provide fully integrated services from antibody discovery through commercial GMP manufacturing, specializing in ADCs, AOCs, RDCs, mAbs, fusion proteins, and bispecifics. With over 1,400 lead candidates discovered, 100+ production cell lines developed, and 2,000+ bioconjugates produced, they operate state-of-the-art facilities in San Diego, Bristol (PA), and Cambridge (UK).

ACIC Pharmaceuticals Inc

Canada

ACIC Pharmaceuticals Inc is a CDMO headquartered in Coral Springs, Florida, providing integrated pharmaceutical solutions from molecule to market. They offer API manufacturing, CDMO services for complex injectables including long-acting and cytotoxic injectables, regulatory support, and pharmaceutical equipment solutions. They have 249 FDA-approved products across a wide range of dosage forms.

Acino International AG

Switzerland

Acino International AG is a Swiss pharmaceutical company headquartered in Zurich, operating as a CDMO specializing in oral solid dosage forms. With over 50 years of manufacturing experience, they operate facilities in five countries with annual capacity of billions of tablets and millions of capsules. They specialize in advanced drug delivery systems including multi-unit pellet systems (MUPS), minitablets, and complex modified-release formulations.

ACS DOBFAR S.p.A.

Italy

ACS DOBFAR S.p.A. is an Italian pharmaceutical company established in 1973, specializing in anti-infective APIs (Cephalosporins, Carbapenems, Penicillins) and finished dosage forms. With 23 production facilities across four continents and over 3,000 employees, they operate as both an API manufacturer and a CMO for multinational pharmaceutical companies. They are approved by AIFA, FDA, ANVISA, and Health Canada.

Adamed Pharma S.A.

Poland

Adamed Pharma S.A. is a European pharmaceutical and biotechnology company headquartered in Poland, established in 1986. They manufacture approximately 94 million units of medicine packs annually across 19 therapeutic areas, with products available in dozens of markets. They hold GMP and GDP API certifications, and operate as both a manufacturer of their own products and a licensee, with 256 pharmaceutical patents and approximately 900 SKUs.

Addii Biotech Pvt Ltd

India

Addii Biotech Pvt Ltd is an Indian pharmaceutical company established in 2010, initially as a marketing company that expanded into manufacturing in 2017. They manufacture tablets, capsules, ointments, dry syrups, and other preparations at their WHO-GMP certified facility in Baddi, Himachal Pradesh. They hold ISO 9001:2015, WHO-GMP, and FDA-Ghana certifications and supply to government institutions and hospitals.

Adelco SA

Greece

Adelco S.A. is one of the oldest pharmaceutical and cosmetics manufacturers in Greece, established in 1934. They operate as both a CMO/CDMO and a branded pharmaceutical and cosmetics manufacturer. Their EU-GMP certified production facility manufactures a range of pharmaceutical products including tablets, capsules, liquids, creams, and ointments. They are an independent manufacturer extending activities beyond Greek national borders.

Afric Phar

Morocco

Afric-Phar is a Moroccan pharmaceutical company offering contract manufacturing services with a complete value chain including regulatory affairs, quality assurance, quality control, production, logistics, and promotion. The company operates from a 1,300 m2 industrial site and provides global contract services for pharmaceutical partners entering the North African market.

AGC (AGC Biologics & AGC Pharma Chemicals)

United States

AGC Biologics is a leading global CDMO providing contract development and manufacturing services for biologics, cell and gene therapies, and advanced modalities. With facilities in Seattle, Copenhagen, Heidelberg, Milan, Chiba, and Yokohama, AGC operates mammalian and microbial expression systems and offers end-to-end services from process development through commercial-scale manufacturing.

Aggrega Pharma, LLC

France

Aggrega Pharma LLC is a U.S.-based pharmaceutical company created in 2019 by four European-based pharmaceutical companies (Bluepharma, Rafarm, Substipharm, Welding) focused on developing, manufacturing, and marketing generic drug products. The company leverages its shareholders' development and commercial manufacturing facilities, including FDA-inspected sites in Portugal and Greece, with capabilities in oral solids, sterile injectables, and complex ophthalmics.

Agilent Advanced Therapeutics

United States

BioVectra is a Canadian full-service CDMO specializing in biologics, small molecules, nucleic acids, and fill/finish, now a part of Agilent Technologies. With over 50 years of pharmaceutical manufacturing experience, the company leverages microbial fermentation expertise and complex chemistry to support partners from clinical to commercial stage. BioVectra operates multiple manufacturing facilities in Canada and recently opened a 36,000 sq ft mRNA facility as part of a $90M expansion in Charlottetown.

Agno Pharmaceuticals

United States

Agno Pharmaceuticals is a U.S.-headquartered global end-to-end CDMO providing comprehensive solutions from API development and intermediates through complex drug product formulation to cGMP manufacturing for both clinical trials and commercial production. The company supports both innovative and generic pharmaceutical sectors with capabilities in small molecule APIs, highly potent APIs (HPAPIs), sterile APIs, and drug products.

Aizant Drug Research Solutions

India

Aizant Drug Research Solutions Pvt. Ltd., founded in 2008, is a trusted global CDMO offering comprehensive API and Formulation R&D, CDMO, CMO, and CRO services across multiple therapeutic areas and dosage forms. The company operates USFDA and EU-accredited facilities with capabilities in hot melt extrusion, spray drying, and complex generics, providing end-to-end pharmaceutical development and manufacturing solutions.

Ajinomoto Bio-Pharma Services

Belgium

Ajinomoto Bio-Pharma Services (Aji Bio-Pharma) is a fully integrated global CDMO providing comprehensive development and cGMP manufacturing services for both small and large molecule pharmaceuticals. With facilities in Belgium, the United States, Japan, and India, the company offers platform technologies including oligonucleotide manufacturing, ADC conjugation, small molecule API synthesis, and aseptic fill-finish services. The Althea fill-finish site was acquired by PCI Pharma Services.

Akriti Pharmaceuticals Pvt. Ltd.

India

Akriti Pharmaceuticals Pvt. Ltd. is an Indian pharmaceutical manufacturer with EU GMP and TGA approved manufacturing facilities. The company delivers affordable quality medicines across the world with efficient manufacturing services backed by a qualified technical team, operating as a contract manufacturer for global healthcare partners.

Akums Drugs & Pharmaceuticals Ltd

India

Akums Drugs & Pharmaceuticals Ltd. is India's largest CDMO with 30% domestic market share, operating 15+ state-of-the-art manufacturing facilities with over 4,100 commercialized formulations across 60+ dosage forms. The company serves 1,500+ pharmaceutical companies and provides end-to-end services including API manufacturing (737 MT annual capacity across 3 facilities), formulation development, clinical trial materials, and commercial-scale production of tablets, capsules, injectables, soft gels, syrups, topicals, and nutraceuticals.

Almac Group

Ireland

Almac Group is a major global CDMO with 55+ years of experience, 7,800+ employees, and 18 facilities worldwide. The company provides end-to-end pharmaceutical services including API manufacture, formulation development, clinical trial supplies, commercial-scale manufacturing, packaging, serialization, and distribution, with additional capabilities in precision medicine diagnostics and drug discovery. Almac has contributed to approximately 50% of approved NMEs in the last 6 years.

Alpex Pharma SA

Switzerland

Alpex Pharma is a Swiss research-based pharmaceutical company and CDMO with 37+ years of experience, offering end-to-end drug development from API to finished pharmaceutical product. The company specializes in oral dissolving tablets (ODTs) with 100+ patents and has commercialized 150+ products with 200+ million units sold annually. Facilities are FDA, Swissmedic, EU-GMP, and BRC-FOOD approved.

Altruist Biologics

China

Altruist Biologics is a China-based biologics CDMO backed by Innovent Biologics, offering end-to-end development and GMP manufacturing for monoclonal antibodies, bispecific/multispecific antibodies, fusion proteins, recombinant proteins, and antibody-drug conjugates (ADCs). The company operates large-scale facilities in Suzhou (60,000L) and Hangzhou (172,000L) with bioreactors from 1,000L to 20,000L, achieving a 99.8% batch success rate and 180+ global regulatory approvals.

Alvotech

Czech Republic

Alvotech is a vertically integrated biosimilar company specializing in the development and manufacturing of high-quality biosimilar biologic medicines. The company operates from cell line development through fill and finish manufacturing, with FDA-registered facilities and operations spanning API manufacture, labeling, manufacturing, and packaging.

Amaran Biotechnology Inc.

Taiwan

Amaran Biotechnology Inc. is a Taiwan-based CDMO established in 2010, providing drug process development, manufacturing, and analytical services. The company specializes in drug substance manufacturing including bio-conjugation, purification, and lyophilization, as well as aseptic drug product filling with robotic systems in a PIC/S GMP-certified facility.

AMN Life Science Pvt Ltd

India

AMN Life Science Pvt Ltd is an Indian pharmaceutical company headquartered in Mumbai, engaged in pharmaceutical product development and manufacturing of formulations for international markets. The company manufactures a range of oral solid dosage and oral liquid products across therapeutic areas including gastrointestinal, antibiotics, and nutraceuticals, with EU GMP and WHO cGMP certifications.

Antibiotice S.A.

Romania

Antibiotice S.A. is a Romanian pharmaceutical company with over 70 years of experience, specializing in the manufacturing of antibiotics (injectable and oral), APIs, and nystatin. They hold FDA approval for injectable ampicillin, nafcillin, and nystatin API, and operate eight GMP-certified manufacturing lines. They provide contract manufacturing services for APIs and finished products.

APL (Apotek Produktion & Laboratorier AB)

Sweden

APL (Apotek Produktion & Laboratorier AB) is a Swedish state-owned pharmaceutical company and one of Europe's leading companies in development, analysis, and manufacturing of extemporaneous and stock preparations. They also operate as an established CDMO for the life science industry, offering formulation development, analytical method development, stability studies, and sterile manufacturing. They have invested in 3D printing technology for automated drug dispensing.

Apotex (incl. Apotex Pharmachem)

Canada

Apotex is Canada's largest pharmaceutical company with global operations spanning API manufacturing, finished dosage form production, and CDMO/co-development services. With capacity to produce approximately 25 billion finished doses annually and three API manufacturing sites, they serve both their own generic portfolio and external partners through Apotex Pharmachem (API CDMO) and Apotex Fermentation (fermentation-based manufacturing).

Aprecia Pharmaceuticals

United States

Aprecia Pharmaceuticals is a Cincinnati-based CDMO that pioneered the use of 3D printing (binder jet 3DP) technology for pharmaceutical manufacturing. Their proprietary ZipDose technology platform produces rapidly disintegrating oral solid dosage forms. They hold FDA-registered facilities with operations spanning analysis, API manufacture, labeling, manufacturing, and packaging. They have FDA-approved products including tablets and oral suspensions.

AqVida GmbH

Germany

AqVida GmbH is a German CDMO specializing in sterile oncology injectable products. Based in northern Germany, they manufacture cancer medicines using a state-of-the-art robotic filling line designed for aseptic production of cytostatics for parenteral use. Their facility features OEB5 containment with isolator technology for handling toxic parenteralia, with vial sizes from 2 to 100ml and batch sizes of 5 to 300 liters. They also provide GMP consulting services.

Aragen Life Sciences Ltd.

India

Aragen Life Sciences Ltd. (formerly GVK Biosciences) is a CRDMO (Contract Research, Development, and Manufacturing Organization) headquartered in Hyderabad, India, with over 4,000 scientists. They provide integrated services spanning small molecules and large molecules (biologics) from discovery through commercialization. Their capabilities include HPAPI handling (cytotoxics, immunosuppressants, ADC toxins), particle science, process validation, and IND enabling services across multiple FDA-registered facilities.

Ardena

Belgium

Ardena is a Belgian-headquartered global specialist CDMO and CRO focused on precision medicine development of complex and innovative molecules, with a leading position in nanomedicine development. They offer integrated services spanning drug substance manufacturing, drug product manufacturing (oral solids, injectables, nanomedicines), bioanalytical testing, and CMC regulatory support. Their multi-site network includes capabilities for HPAPI manufacturing, spray drying, hot melt extrusion, and aseptic sterile manufacturing.

Ascendia Pharmaceutical Solution

United States

Ascendia Pharmaceutical Solutions is a CDMO specializing in formulation development and cGMP manufacturing of drug products. Known for novel enabling technologies such as NanoSol (nanoparticle), AmorSol (amorphous solid dispersion), EmulSol (nano-emulsion), and LipidSol (lipid nanoparticle), they help partners advance poorly soluble compounds from pre-formulation through commercialization.

ASCIL Biopharm (Ascil Proyectos S.L.)

Spain

ASCIL Biopharm (Ascil Proyectos S.L.) is a clinical-stage drug delivery systems company based in Spain, specializing in controlled-release formulations and precision medical devices. They also act as a CDMO for early-stage drug product development, providing formulation, analytics, and manufacturing services for injectable depot formulations.

ASM Aerosol-Service AG

Switzerland

ASM Aerosol-Service AG is a Swiss contract manufacturer specializing in pharmaceutical aerosols, metered dose inhalers (MDIs), nasal sprays, and medical devices. They provide development services from feasibility studies through formulation, stability testing, regulatory support (EU dossiers), pilot and scale-up production, clinical samples, and full-scale commercial batch manufacturing.

AsymBio (Asymchem Group)

China

AsymBio, a strategic business unit of Asymchem Group (stock code: 002821.SZ / 6821.HK), is a biologics CDMO focused on antibodies, recombinant proteins, bioconjugates (including ADCs), and mRNA. They provide end-to-end services from cell line construction through commercial manufacturing, with a 130,000+ sq meter Shanghai Fengxian facility featuring 200L/500L/2000L single-use bioreactors. They have supported FDA IND approvals for partners including Radiopharm Theranostics.

Asymchem

China

Asymchem is a leading CDMO with 25+ years of experience, 9,700+ employees, and eight R&D and manufacturing sites. They specialize in complex chemistry for small molecule APIs, including peptide synthesis, and provide comprehensive CMC services from R&D through commercial production. They have 65+ successful regulatory inspections (FDA, NMPA, TGA, MFDS) and 1,100+ active clients with 600+ clinical and 40+ commercial projects.

AtomVie Global Radiopharma Inc.

Canada

AtomVie Global Radiopharma Inc. is a leading radiopharmaceutical CDMO dedicated to cGMP manufacturing and global distribution of radiopharmaceuticals. They specialize in radiolabeling with isotopes including Lu-177, Ac-225, I-131, In-111, Zr-89, and Tb-161. They have delivered 3,000+ doses to 26 countries with >99% accuracy. Their new 72,300 sq ft Hamilton, Ontario facility (opening 2026) will have 18+ production lines and 10x current capacity. Clients include Radiopharm Theranostics, Cellectar, and POINT Biopharma.

Aton Biotech

China

Aton Biotech is a China-based biologics CDMO backed by Henlius Biotech, offering one-stop solutions from early development to commercial production. They provide services in process development, GMP manufacturing, analytical testing, and ADC development. With access to up to 144,000L bioreactor capacity from parent company Henlius, they focus on monoclonal antibodies, recombinant proteins, and antibody-drug conjugates.

Aurigene Services

India

Aurigene Pharmaceutical Services (formerly Aurigene Services) is a leading global CRDMO with 25+ years of experience, offering integrated CRO (discovery) and CDMO services for both small and large molecules. The company provides end-to-end drug development solutions from target identification through commercial manufacturing, operating 16 USFDA-approved sites. Aurigene has 700+ scientists, 400+ completed projects, and 18 successfully commercialized NCEs. Their small molecule CDMO capabilities span drug substance development and manufacturing, formulations, and specialty areas including peptides, high potent APIs, mPEGs, steroids, carbohydrates, and flow chemistry. Their biologics division offers process development and clinical scale manufacturing for monoclonal antibodies, bispecific antibodies, and proteins, with a new biomanufacturing facility in Hyderabad.

Avid Bioservices, Inc.

United States

Avid Bioservices, Inc. is a dedicated biologics CDMO based in Costa Mesa, California, with 30+ years of experience in mammalian cell culture-based biologics manufacturing. The company provides end-to-end drug substance and drug product services for monoclonal antibodies, bispecific antibodies, enzymes, and recombinant proteins. Avid operates from its main facility plus a new 78,000 sq ft Early Phase Center of Excellence (opened February 2026) for early-stage development. Services include cell line development, process development, analytical method development, cGMP manufacturing, and late-stage clinical and commercial biologics production. Avid has built a track record as one of the few US-based pure-play biologics CDMOs.

Avrio Biopharma (Avrio Biopharmaceuticals, LLC)

United States

Avrio Biopharmaceuticals LLC is a US-based CDMO operating a cGMP facility focused on clinical trial services, formulation development, aseptic fill and finish, lyophilization, CMC support, and packaging and labeling. They offer comprehensive pre-formulation services, parenteral and solid/semisolid/liquid dosage form development, lyophilization cycle development, ophthalmics, emulsions, suspensions, and liposome/microsphere encapsulation. The company also provides clinical trial management, regulatory submissions support, and has received California Drug Manufacturing and Medical Device Manufacturing licenses. Their product portfolio includes generic formulations of gabapentin, pregabalin, and modafinil.