Regulatory Support CDMOs

Sterling Italy (Sterling S.p.A.) is a long-established Italian manufacturer specializing in the development, optimization, and manufacturing of steroidal APIs including corticosteroids, hormones, anabolics, estrogens, and progestinics. The company operates GMP production plants in Perugia, Italy and exports APIs to over five continents.

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.

Division of Terumo Corporation (TSE:4543), a global healthcare technology leader since 1921 with 30,000+ employees. Provides sterile injectable contract development and manufacturing (CDMO) services from combination device design and formulation development to commercial manufacturing. Offers a portfolio of injection, infusion, and primary packaging solutions including PLAJEX polymer pre-fillable syringes, Immucise intradermal injection systems, hypodermic needles, and Surflo winged infusion sets. Recently expanded CDMO services outside Japan for global market and is doubling capacity.

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.

WeylChem

Germany

WeylChem is the fine and specialty chemicals platform of International Chemicals Investors Group, operating as a CDMO for custom manufacturing of fine chemicals and pharmaceutical intermediates. With nine companies and around 1,400 employees across seven manufacturing sites in Europe, North America, and Asia, WeylChem provides custom synthesis from pilot scale through to large-scale commercial production in vessels up to 20 cubic meters.

Yuhan CDMO (Yuhan Chemical)

South Korea

Yuhan Chemical Inc. is a South Korean company and the API CDMO arm of Yuhan Corporation, focused on custom development and manufacturing of active pharmaceutical ingredients, intermediates, and regulated starting materials. Founded in 1980, it operates the largest API production capacity in Korea (~500,000L reactor volume) across Ansan and Hwaseong plants.

Yuki Gosei Kogyo Co., Ltd.

Japan

Yuki Gosei Kogyo Co., Ltd. is a Japanese fine chemical manufacturer providing GMP-compliant contract manufacturing of pharmaceutical intermediates, new drugs, and generics. The company has extensive experience in drug development, manufacturing, and commercialization, exporting to more than 30 countries worldwide.

Zambon is an Italian multinational healthcare group founded in 1906 with EUR 899 million in revenues and 2,768 employees. The group operates as both a pharmaceutical company (Zambon Pharma) and a CDMO, offering contract development and manufacturing services ranging from development through commercial production. Manufacturing plants in Vicenza (Italy), Cadempino (Switzerland), Haikou (China), and Barueri (Brazil) supply 87 countries. Also includes Zach System (API custom synthesis) as its chemical division.

Zhejiang Davi Pharmaceutical Co., Ltd., established in 2004, is an exclusively foreign-owned high-tech manufacturer of active pharmaceutical ingredients and intermediates located in Huzhou City, Zhejiang, China. With a total investment of $8M USD and 35,000 m2 floor space, they operate FDA and COS-required GMP workshops. They specialize in folate-related APIs: Methotrexate, Methotrexate Sodium, Calcium Folinate (Leucovorin Calcium), Calcium Levofolinate, and L-5-Methyltetrahydrofolate Calcium. The company is FDA-registered with 3 FEI numbers, has 8 FDA inspections (2 NAI, 6 VAI, 0 OAI), 1 Class II recall, 4 FDA-approved products (tablet, extended-release tablet), and participates at CPHI events globally. They undertake OEM orders for intermediates. Classified as API manufacturer rather than CDMO because they primarily manufacture their own specialty APIs; contract services appear limited to OEM intermediate orders.

Acebright Group (Shanghai Acebright Pharmaceuticals) is a Chinese pharmaceutical company providing CDMO services through NMPA, FDA, EMA, and WHO-approved sites. They specialize in API manufacturing with over 20 years of technology development, and have a joint venture with Cipla for respiratory products in China.

Amarex Clinical Research, LLC

United States

Amarex Clinical Research, LLC is a full-service global Contract Research Organization (CRO) co-founded in 1998 and acquired by NSF International. The company provides clinical trial management, regulatory affairs, biostatistics, data management, pharmacovigilance, and medical writing services across all phases of drug development.

Aurisco Pharmaceutical Co., Ltd. is a CRDMO (contract research, development and manufacturing organization) headquartered in Taizhou, Zhejiang, China, specializing in generic and complex APIs and finished dosage forms. The company focuses on small-molecule drugs, peptide therapeutics, and oligonucleotide pharmaceuticals. Aurisco operates 4 manufacturing sites and 5 R&D centers in China with 1,500+ staff, has passed 5 cGMP inspections in 2023 (USFDA, EUGMP, PMDA, NMPA, KFDA), and is expanding peptide manufacturing capacity. Their steroid product portfolio includes abiraterone acetate and complex hormone formulations.

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.

Chanelle Pharma is Ireland's largest indigenous pharmaceutical manufacturer producing both human health and veterinary products. The company operates 4 manufacturing facilities with 550 employees, holding 1,200+ human health licenses, and provides contract manufacturing services for B2B pharmaceutical customers. Chanelle Pharma was acquired by the private equity firm Exponent and has appointed a new CEO to drive international growth, with manufacturing plants in Ireland and near Rome, Italy.

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.

Chongqing Huapont Shengchem Pharmaceutical Co., Ltd., founded in 1994, is a subsidiary of listed company Huapont Life Sciences. The company provides integrated R&D, production, and CDMO services for APIs and intermediates with 30+ years of experience, 700m3 reaction volume, 100+ R&D products, and registrations across US, EU, Japan, Korea, and China.

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.

Cromos Pharma Ireland Ltd

Ireland

Cromos Pharma is a US-based international contract research organization (CRO) with expertise in Central and Eastern Europe, Central Asia, and Turkiye. The company offers clinical trial services including multicountry feasibility, site management, patient recruitment with their No Patients No Payment program, and regulatory consulting from early- to late-phase studies.

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.

Erregierre SpA

Italy

Erregierre SpA is an Italian API manufacturer founded in 1974, specializing in medium-volume small molecule active pharmaceutical ingredients for human and veterinary use. Located near Bergamo in Northern Italy, the company operates 55 glass-lined and stainless-steel reactors (70 to 10,000 liters) and provides DMF and dossier submission support for highly regulated markets including the US, Japan, South Korea, and Europe.

Flamma Group

China

Flamma Group is a privately held, family-owned small molecule CDMO with experience since 1950, offering cGMP manufacturing of APIs, new chemical entities (NCEs), registered starting materials (RSMs), and pharmaceutical intermediates. The company operates FDA-inspected facilities in Italy, a GMP site in the USA (Philadelphia area), and a GMP facility in Dalian, China, providing services from early-stage development to commercial-scale manufacturing.

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.

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.

Galenica S.A.

Greece

Galenica S.A. is a Greek pharmaceutical company founded in 1974, operating two EU-GMP certified and FDA-approved manufacturing facilities in Chalkida and Kryoneri. The company offers Contract Manufacturing Operations (CMO) producing injectables, solids, liquids, and semi-liquids for third parties. Galenica also markets its own prescription and OTC medicines and exports to over 18 countries.

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.

Gennex Laboratories Limited

India

Gennex Laboratories Limited is an Indian Active Pharmaceutical Ingredient (API) manufacturing company established in 1995, located in IDA Bollaram, Hyderabad. The company is a vertically integrated pharmaceutical manufacturer with a product portfolio spanning expectorants, muscle relaxants, analgesics, and antifungals. Gennex holds FDA registration and has been inspected by the FDA with NAI/VAI outcomes.

Goodwin Biotechnology (GBI) is a full-service biopharmaceutical CDMO based in Florida, specializing in biologics development and manufacturing. Named Manufacturer of the Year by BioFlorida, GBI offers its Single-Source Solution for monoclonal antibodies, ADCs, recombinant proteins, and other complex biologics from cell line development through cGMP commercial manufacturing. The company provides mammalian cell culture manufacturing using CHO and other expression systems.

Harvest Integrated Research Organization (HiRO)

Australia

Harvest Integrated Research Organization (HiRO) is a full-service global Contract Research Organization (CRO) providing end-to-end clinical trial services. The company focuses on clinical research and regulatory support across global markets.

Huayi Pharmaceutical (Anhui) Co., Ltd. is an EU cGMP-approved Sino-British joint venture CDMO located in Hefei, Eastern China. The company specializes in contract development and manufacturing of high-quality generic pharmaceuticals across various dosage forms, offering integrated services from API production through finished dosage form manufacturing.

HydRegen Limited

United Kingdom

HydRegen Limited is a UK-based biotechnology company specializing in biocatalysis and sustainable chemistry for pharmaceutical intermediates. The company develops proprietary enzyme platforms including H2BioCat for asymmetric reductions and Bio2Amine for nitro-to-amine reductions, partnering with companies like Almac Sciences and Ingenza.

Indero

Canada

Indero (formerly Innovaderm) is a Canadian full-service clinical research organization (CRO) specializing in dermatology and rheumatology clinical trial delivery. The company offers early and late phase trial services spanning North America, Europe, Latin America, and Asia-Pacific, with expertise in immune-mediated diseases.

Intertek

Canada

Intertek is a global quality assurance provider operating over 1,000 locations in 100+ countries, with specialized pharmaceutical services including GLP/GCP/GMP contract laboratory expertise, CMC analytical services, method development and validation, stability testing, and formulation development. The company has over 30 years of pharma experience with particular expertise in inhaled and nasal drug delivery systems and biopharmaceutical characterization.

I Peace Inc. is a Palo Alto, California-based biotech CDMO specializing in cGMP manufacturing of iPSC (induced pluripotent stem cells) and iPSC-derived cell products for cell and gene therapy development. The company provides custom GMP cell manufacturing, process development, cell banking (MCB/WCB), gene editing, differentiation services, and regulatory support compliant with FDA, PMDA, and EudraLex standards. I Peace has manufactured 100+ GMP iPS cell lines and tripled its CDMO facility capacity.

IQVIA

Australia

IQVIA is a global leader in clinical research services, commercial analytics, and healthcare data technology, serving the pharmaceutical and life sciences industry. Named to Fortune's Most Admired Companies for nine consecutive years, IQVIA provides clinical trial management, real-world evidence, safety and regulatory compliance, and commercialization services powered by AI and Connected Intelligence. IQVIA does not manufacture drugs but provides CRO and data analytics services.

JSR Life Sciences (KBI Biopharma / Selexis)

Switzerland

JSR Life Sciences is the parent organization of KBI Biopharma (CDMO) and Crown Bioscience (CRO), plus Selexis (cell line development). KBI Biopharma is a biologics CDMO providing mammalian and microbial expression, process development, analytical development, and clinical through commercial GMP manufacturing. Crown Bioscience is a separate CRO arm focused on preclinical oncology. This entity spans CDMO and CRO, but the primary CDMO identity is through KBI Biopharma. FDA registered with 4 FEI numbers and 5 inspections (4 NAI, 1 VAI).

Jubilant Biosys Limited

India

Jubilant Biosys is a CRDMO (Contract Research, Development and Manufacturing Organization) under Jubilant Pharmova. Over 20 years experience, 2,400+ employees, five sites across India and Europe. Offers integrated drug discovery (IDD), chemistry services, biology services, and CDMO services including process R&D, analytical development, technology transfer, GLP/non-GMP/GMP manufacturing. Recently expanding into biologics and ADC discovery at European site. FDA registered with 3 FEI numbers, 14 inspections including 4 OAI -- regulatory risk flag. Note: Website claims biologics/ADC capability but this is at discovery stage only, not GMP manufacturing.

Kaisha Lifesciences Pvt. Ltd

India

Kaisha Lifesciences is a pharmaceutical company under the Dadachanji Group of Companies (30+ year heritage), offering contract R&D services from product development to scale-up, plus its own product portfolio. Part of a diversified group including Schott Kaisha (glass vials, 50% acquired by Serum Institute of India), Kaisha Packaging, and Kaisha Medisurge. WHO-GMP certified manufacturing facility for terminally sterilized and aseptically filled injectables in ampoules, vials (liquid and lyophilized), and pre-filled syringes. Departments include formulation development, analytical development, quality assurance, and regulatory affairs. Products include Enoxaparin Sodium Injection. First Indian patent approval 2021.

KBI Biopharma

Switzerland

KBI Biopharma is a global biologics CDMO (part of JSR Life Sciences) providing mammalian and microbial-based biopharmaceutical development and manufacturing services. Offers cell line development (SUREtechnology Platform powered by Selexis for CHO, PUREplatform for E. coli), process development, analytical development, formulation development, characterization, clinical and commercial GMP manufacturing. FDA registered (FEI 3004638264) with ANALYSIS, API MANUFACTURE, and MANUFACTURE operations. Positioned as a 'next-generation CDMO' with standalone services portal for analytical testing.