Regulatory Support CDMOs

ProMed Pharma

United States

ProMed Pharma is a US-based CDMO specializing in long-acting injectable and implantable dosage forms with nearly 20 years of operational history. The company has mastered polymer-based drug delivery including molding, extrusion, and microencapsulation techniques using silicones, thermoplastics, and biodegradable excipients. ProMed supports projects from early-stage feasibility through commercial manufacturing and has expanded with the acquisition of a 28,000 sq ft facility in Plymouth, Minnesota.

Pyramid Laboratories

United States

Pyramid Laboratories (now Pyramid Pharma Services) is a California-based CDMO established in 1988, specializing in aseptic manufacturing, development, and analytical services for parenteral drugs. The company supports biologics, peptide, and small molecule drugs from pre-clinical development through commercial supply. Pyramid operates a 90,000 sq ft GMP-compliant facility in Costa Mesa, California, and has received investment from Audax Private Equity.

Renaissance Lakewood, LLC

United States

Renaissance Lakewood is a US-based pure-play CDMO specializing in nasal spray and sterile injectable dosage forms. Founded in 1979 (originally Paco Packaging Labs), they have nearly 20 years of nasal spray experience and offer bench-to-shelf services including formulation development, spray characterization, clinical through commercial manufacturing. Recently acquired by LTS Lohmann Therapie-Systeme AG to expand LTS's CDMO capabilities. FDA-registered with manufacturing, analysis, labeling, and packaging operations in Lakewood, NJ. They have invested over $100M in facility improvements over the past five years.

Rentschler Biopharma

Germany

Rentschler Biopharma is a leading global CDMO focused exclusively on biopharmaceuticals, with over 50 years of industry experience. The company contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023, has supported 180+ biotherapeutics, and serves 180+ clients worldwide. It is an independent family-owned company employing approximately 1,400 people.

Rivopharm SA

Switzerland

Rivopharm SA is a Swiss-based pharmaceutical company focused on the development, manufacture, and marketing of generic pharmaceutical products at a global level. Founded in 1961 and headquartered in Manno (Lugano), the company offers a portfolio of over 100 molecules with more than 2,000 SKUs across a wide range of therapeutic areas. Rivopharm operates internationally through subsidiaries in the UK, Germany, and the Baltics, and has 87 FDF dossiers and 4 FDA registrations.

Sava Healthcare Ltd

India

SAVA Healthcare Ltd is an Indian pharmaceutical company established in 2003, headquartered in Pune with a WHO-GMP and PIC/s approved manufacturing facility in Surendranagar, Gujarat. The company offers CDMO/CRAMS services and is a leading manufacturer of nasal drug delivery platforms, producing nasal sprays and drops, dry powder inhalers, oral solid doses, and topical preparations.

ScinoPharm (scinopharm.com)

China

ScinoPharm Taiwan is a CDMO headquartered in Tainan Science Park, Taiwan, specializing in high-tech oncology APIs, peptide synthesis, and sterile injectable drug products. With FDA-approved facilities and 18 flexible manufacturing lines, ScinoPharm provides end-to-end services from API development through sterile injectable fill/finish, with a strong focus on complex generics and oncology therapeutics.

Senores Group

India

Senores Group (Senores Pharmaceuticals Limited) is an India-based CDMO specializing in complex generic oral solid dosage forms and API manufacturing. The company operates 5 manufacturing facilities including 2 USFDA-approved formulation plants (Atlanta, USA and Gujarat, India) and 2 API/intermediates plants. Senores serves 300+ customers in 49 countries, with particular strength in controlled substances (C2-C5), extended-release, and orally disintegrating tablet formulations.

Serumwerk Bernburg AG

Germany

Serumwerk Bernburg AG is a medium-sized German pharmaceutical company with over 60 years of tradition in the development and production of medicines, medical devices, and APIs. The company offers APIs and contract manufacturing (Lohnproduktion) services, manufactures sterile infusion and rinsing solutions for hospitals and dialysis centers, ophthalmic products, veterinary medicines, wound care products, and specialty biopolymer-based formulations. Serumwerk has FDA-registered API manufacturing and exports to partners in 60+ countries.

Servier (Servier CDMO)

France

Servier CDMO is the contract manufacturing arm within the global pharmaceutical company Servier, bringing 60 years of expertise in drug product manufacturing and packaging. With 9 manufacturing sites and 16 locations globally, Servier CMO offers services from development through commercial-scale production of tablets, capsules, and powders, distributing over 450 million boxes annually across 150 countries.

Sever Pharma Solutions

France

Sever Pharma Solutions is a specialized CDMO focused on high-potent and cytotoxic drug products (up to OEB6), polymer-based controlled-release delivery systems (implants, vaginal rings), hot melt extrusion for bioavailability enhancement, and prefilled syringe/autoinjector aseptic fill-finish. With sites in Malmö (Sweden) and Putnam (Connecticut, USA), they offer end-to-end services from formulation development through commercial manufacturing.

Simtra BioPharma Solutions

Germany

Simtra BioPharma Solutions is a global CDMO focused exclusively on sterile injectable drug products. With over 65 years of expertise, Simtra offers formulation development, lyophilization cycle optimization, technology transfer, analytical services, fill/finish operations, specialized containment, and global regulatory support. They handle cytotoxics, highly potent compounds, biologics, vaccines, small molecules, ADCs, and diluents. They have a strategic alliance with MilliporeSigma for ADC manufacturing. The company has transferred 60+ ADC candidates including six commercial products to their German site.

SK bioscience

South Korea

SK bioscience is a South Korean vaccine-focused biopharmaceutical company that also operates as a CDMO. Listed on KOSPI (302440), they develop proprietary vaccines (influenza, varicella, COVID-19, pneumococcal, HPV, RSV) and provide CDMO/CMO services for vaccine manufacturing. They acquired a controlling stake in German CDMO IDT Biologika for approximately $244M, gaining manufacturing sites in Dessau (Germany) and Rockville (Maryland, USA). SK bioscience collaborates with the Bill & Melinda Gates Foundation, CEPI, and international vaccine initiatives. They have WHO prequalified products.

SpectronRx

Belgium

SpectronRx is a radiopharmaceutical CDMO headquartered in Belgium with manufacturing facilities in Indiana, USA, and Danbury, Connecticut. The company specializes in end-to-end radiopharmaceutical and theranostic services including mAb, nanobody, and peptide radiolabeling with a wide range of isotopes (Ac-225, Pb-212, Lu-177, I-123/131, Cu-64/67, etc.), isotope production via cyclotron (16-70 MeV), worldwide cold-chain logistics, and regulatory consulting from IND filing through FDA approval. They operate 3 CDMO facilities with multiple cleanrooms and GMP-aligned space totaling approximately 200,000 sq-ft.

Standard Chem. & Pharm. Co. Ltd

Taiwan

Standard Chem. & Pharm. Co., Ltd. (SCP), established in 1967 in Taiwan, is a renowned global pharmaceutical manufacturer and CDMO with a strong international presence. Their investor materials and pharma alliance documents explicitly describe them as offering CMO/CDMO services. They have manufacturing plants in Tainan (Plant 1 and Plant 2) and operations in Vietnam, Philippines, Thailand, Samoa, China (Taizhou/Jiangsu and Shanghai). The company has collaborated with major Japanese pharmaceutical companies and offers drug development and innovative drug delivery systems. They are a publicly listed company on the Taiwan stock exchange (Stock Symbol: 1720).

Stira Pharmaceuticals (Sterile Injectable CDMO)

United States

Stira Pharmaceuticals is a U.S.-based CDMO specializing in the development and cGMP manufacture of complex sterile injectable products, with integrated analytical capabilities. Founded in 2019, the company serves the U.S. market with services spanning small molecules, peptides, oligonucleotides, and biosimilars in formats including vials, syringes, IV bags, and cartridges with batch sizes up to 2,000L.

Sumitomo Chemical Co., Ltd.

Japan

Sumitomo Chemical Co., Ltd. is a major Japanese chemical company whose Advanced Medical Solutions Sector provides CDMO services for small molecule APIs and intermediates, oligonucleotide production (including gRNA for genome editing), and regenerative medicine/cell therapies through its S-RACMO joint venture with Sumitomo Pharma. The company also operates large agrochemical, IT materials, and essential materials businesses.

Swati Spentose Pvt Ltd

India

Swati Spentose Pvt Ltd is a global research-oriented Indian pharmaceutical company with over 50 years of history, specializing in API and intermediate manufacturing with a strong focus on neglected and rare diseases, particularly interstitial cystitis. The company operates multiple USFDA-inspected API and intermediate manufacturing facilities in Vapi, Gujarat, and holds global FDA accreditations from USFDA, EDQM, PMDA, COFEPRIS, MFDS, WHO-GMP, and others.

Symbiosis Pharmaceutical Services

United Kingdom

Symbiosis Pharmaceutical Services is a world-class sterile fill-finish CDMO based in Stirling, UK, specializing in the GMP manufacture of liquid and lyophilized biological and small molecule drug products. The company serves clinical trial and commercial scale with FDA-inspected and MHRA-licensed facilities. Symbiosis has manufactured its first 10,000-vial commercial batch for a cancer immunotherapy currently in Phase III trials. The company handles a full range of biologics including ATMPs, viral vectors, mAbs, ADCs, RNA/peptide therapies, and vaccines.

Symeres

Netherlands

Symeres is a leading mid-sized transatlantic Contract Research, Development and Manufacturing Organization (CRDMO) providing integrated drug discovery and development services from idea to IND. With 600+ scientists across 9 global sites in Europe and North America, the company combines medicinal chemistry, ADME-tox, biology, formulation development, analytical services, and GMP manufacturing up to 1,000 L scale. The company recently acquired DGr Pharma and Exemplify BioPharma to expand its CMC capabilities.

Syngene International

India

Syngene International is a leading Indian Contract Research, Development and Manufacturing Organization (CRDMO) that provides integrated services spanning drug discovery through commercial manufacturing for both small and large molecules. The company has long-term research collaborations with Bristol Myers Squibb (extended until 2035) and Amgen. Syngene recently opened its first US manufacturing facility in Rockville, Maryland, and added a bioconjugation suite in Bengaluru for end-to-end ADC development. The company has 20 kL single-use drug substance capacity for biologics.

Sypharma Pty Ltd

Australia

Sypharma is an Australian specialty contract manufacturing group operating since 2005. They develop and manufacture therapeutic goods, veterinary products, and specialty consumer products. They specialize in contract manufacturing for early clinical through Phase III clinical trials and have multipurpose cleanrooms for oral, topical, and parenteral drug products. They manufacture both large and small volume parenterals and have a veterinary manufacturing suite. Licensed by FDA, TGA, and ISO 13485 certified. They partnered with Schott on sterile fill/finish capabilities.

SyVento BioTech

Poland

SyVento BioTech is a Polish biotechnology CDMO specializing in lipid-based nanocarrier formulations and LNP (lipid nanoparticle) technology for mRNA-based drug products. They offer comprehensive CDMO services for pharma and biotech innovators, covering mRNA synthesis and LNP encapsulation. The company opened a new mRNA manufacturing facility (FlexFactory by Cytiva) spanning over 7,000 m2 including lab and production areas. They have partnerships with Cytiva and signed a Letter of Intent with Mabion S.A. for biologics manufacturing collaboration.

Tanvex Biopharma USA, Inc

Taiwan

Tanvex BioPharma USA is a vertically-integrated biopharmaceutical company that has launched a CDMO division (Tanvex CDMO) offering pre-clinical through commercial-scale contract manufacturing of microbial and mammalian-derived biotherapeutics. Founded by Dr. Allen Chao (former founder/CEO of Watson Pharmaceuticals). They received FDA approval for Nypozi (biosimilar filgrastim) and have an FDA-accepted biosimilar BLA. The CDMO offers end-to-end biologics manufacturing services. Their San Diego facility is FDA-registered with 1 approved product (injectable). They have capabilities in both biosimilar development and contract manufacturing for third parties.

TAPI (Teva API)

Netherlands

TAPI (Teva Active Pharmaceutical Ingredients) is the API division of Teva Pharmaceutical Industries, positioned as the world's leading international supplier of APIs with 350+ products in their portfolio. They offer integrated API and CDMO services, leveraging 85+ years of API development and manufacturing expertise. TAPI provides customized solutions including complex API development, peptide manufacturing (including GLP-1 capability), and end-to-end manufacturing. They have a partnership with Antheia for biosynthetic pharmaceutical ingredients and with Sagimet Biosciences for resmetirom API. TAPI operates globally with multiple manufacturing sites.

ten23 health

Switzerland

Swiss CDMO specializing in formulation, analytical and process development, sterile manufacturing (fill and finish), and testing of injectable medicines. First CDMO in the pharmaceutical industry for injectables to be B Corp certified. Operates from Basel and Visp, Switzerland. Opened new VIVA2 facility with expanded sterile manufacturing lines. QC laboratories approved by both Swissmedic/RHI and FDA. Partners with BD on Libertas wearable injector commercialization. Supports biologics, small molecules, and RNA therapeutics.

Thépenier Pharma & Cosmetics

France

French CDMO and OEM-ODM with over 60 years of experience, specializing in development and manufacturing of pharmaceutical, skincare, personal care, and makeup products. Part of an international group with French-Japanese DNA (parent company is Japanese cosmetics manufacturer). All products manufactured in GMP-compliant environment. Pharmaceutical specialization in dermatological products and ENT (ear, nose, throat) sphere products. Revenue of 117M USD (40% export), 850 employees, 70 R&I researchers, 60 engineers/pharmacists. Facilities in Normandy (2 sites) and Orleans, France.

The Ritedose Corporation

United States

The largest US CDMO specializing in sterile Blow-Fill-Seal (BFS) technology for aseptic manufacturing of unit-dose medications. Based in Columbia, South Carolina with a 500,000+ sq ft facility and production capacity of over 2.6 billion units annually. Delivered more than 12 billion doses since 2012 with no patient interruptions. Provides both CDMO services and has a generics division. Offers the largest nebulized drug portfolio in the US. Key products include ophthalmic, respiratory, and inhalation medications. Has co-developed 80%+ of new BFS products over the past decade. 100% customer retention for 25 years. Recent investments include $17M cGMP lab expansion and seventh Syntegon packaging line. 16 FDA-approved products.

Thermo Fisher Scientific Inc.

China

One of the world's largest pharmaceutical CDMOs through its Patheon pharma services division. Provides end-to-end pharmaceutical development and manufacturing services for both small molecules and biologics, from API manufacturing through drug product, sterile fill/finish, packaging, and commercial supply. Operates 31+ FDA-registered facilities globally. 158 FDA inspections on record (52 NAI, 104 VAI, 2 OAI). Also provides cell therapy manufacturing solutions (CTS Rotea cell processing system), laboratory informatics, bioprocessing equipment, and reagents. 4 FDA-approved drug products. Revenue >$40B (full company).

Tiefenbacher Group

Cyprus

Purpose-driven, family-owned healthcare company pioneering healthcare since 1963, headquartered in Cyprus. Delivers best-in-class solutions across the entire pharmaceutical value chain from API distribution through development, manufacturing, and registration of affordable medicines. 900+ employees, 400+ customers, 180+ finished dosage form products, serving patients in 80+ countries. Production capacity up to 3 billion units per year. Manufacturing sites in Cyprus (large-scale oral solid dose, SPC waiver site) and Hyderabad, India (specialized high-potent manufacturing block for oncology, FDA-inspected). Includes Tiefenbacher Laboratories (TBD Pharmatech) as API CDMO division. Offers ICH stability studies, technology transfer, analytical laboratory services, and EU batch testing/release.

Tiofarma

Netherlands

Tiofarma is a Dutch CDMO specializing in complex semi-solid formulations (creams and ointments) and emergency nasal sprays, offering services from pre-formulation through commercial supply. The company operates an EU-GMP and FDA-licensed manufacturing facility in Oud-Beijerland, Netherlands, with in-house R&D and analytical laboratories.

Towa International

Spain

Towa International is the international hub of Japanese generics company Towa Pharmaceutical, headquartered in Barcelona, Spain. The company researches, develops, manufactures, and distributes generic and value-added medicines worldwide, with direct presence in the US (via Breckenridge Pharmaceutical), Europe (Spain, Italy, Portugal), and 40+ countries. Towa International also operates a CMO/CDMO line, offering production capabilities to partners. It recently added a new high-containment area for potent APIs.

UNI-PHARMA S.A.

Greece

UNI-PHARMA S.A. is a major Greek pharmaceutical company (part of the Tsetis Group) with over 60 years of operations. It researches, develops, produces, and distributes pharmaceutical products, food supplements, and medical devices. It holds the first place in sales (units) among purely Greek companies in the Greek pharmaceutical market. The company offers contract manufacturing services (listed as CMO/CDMO on PharmaSource) while also marketing its own extensive portfolio of generic medicines across multiple therapeutic categories. Their product range includes a very wide array of small-molecule generics.

Unolab Manufacturing

Spain

Unolab Manufacturing is a Spanish CDMO founded in 2008, specialized in development and manufacturing of sterile unit-dose liquid formulations using Blow-Fill-Seal (BFS Bottelpack) technology. Focused primarily on ophthalmic and respiratory products including saline solutions, hyaluronic acid formulations, and inhalation products. Operates an 18,000 m2 facility in Getafe, Spain with capacity exceeding 600 million doses per year. Products exported to 25+ countries. Also offers tech transfer, out-licensing, and product development services across the full product lifecycle.

Upperton Pharma Solutions

United Kingdom

Upperton Pharma Solutions is a UK-based CDMO with an award-winning 60,000 sq ft development and manufacturing facility (Trent Gateway) in Nottingham. They provide integrated services from pre-clinical through late-phase manufacture for oral solids, nasal, pulmonary, and parenteral dosage forms. They recently built a new 7 million GBP sterile fill/finish manufacturing facility with MHRA submission. Services include formulation development, clinical supply manufacturing (Phase I-III), process scale-up and optimization, quality control, and analytical development and validation.

URSATEC GmbH

Germany

URSATEC GmbH is a German company founded in 1993 specializing in preservative-free spray dosing systems and contract manufacturing. They are the inventor and market leader in dosing systems for preservative-free sprays using their patented 3K and COMFORT packaging technologies. They offer a 'ONE Source' concept covering product development, raw materials sourcing, dosage systems, sterilization, sterile filling, lab services, and regulatory affairs for pharmaceuticals, medical devices, food supplements, and cosmetics. They operate from Tholey, Germany with ISO 13485, ISO 9001, and ISO 15378 certifications. While they do offer contract filling services for sterile products through qualified partner companies, their primary identity is as a dosing system inventor and preservative-free product specialist.

Viralgen

Spain

Viralgen is a premier CDMO specializing exclusively in AAV-based gene therapy manufacturing, founded in 2017 as a subsidiary of AskBio within the Bayer AG group. Claims the world's largest manufacturing capacity dedicated to AAV. Operates from a cGMP facility in San Sebastian, Spain with bioreactors up to 2,000L. Offers end-to-end services from early construct optimization to commercial campaigns. 50+ clients across US, Europe, Asia, and Australia. 10+ years of lentiviral/AAV experience. 200+ batches in bioreactor. 130+ employees. 7 dedicated cleanrooms. Proprietary TESSA technology platform (from AskBio).

Volcke Aerosol Italy S.r.l.

Italy

Volcke Aerosol is a family-owned contract manufacturer with 55 years of experience specializing in the development and filling of aerosols and sprays. The company operates three production sites in Europe (Belgium, Italy, UK) and provides full-service solutions from formulation development through filling, labeling, and packaging.

Wacker Biotech

Germany

Wacker Biotech is the CDMO division of Wacker Chemie AG, specializing in advanced biologics manufacturing including proteins, plasmid DNA, mRNA, LNP formulations, live microbial products, and vaccines. With over 30 years of experience and five GMP-compliant facilities in Germany, the Netherlands, and the United States, Wacker Biotech offers process development through commercial-scale manufacturing with E. coli-based technology platforms.

Wheeler Bio

United States

Wheeler Bio is a biologics CDMO based in Oklahoma City, specializing in accelerating antibody-based therapeutics from discovery to cGMP clinical supply. The company uses its proprietary Modular CMC approach to reduce risk and accelerate timelines for drug developers. Wheeler Bio offers cell line development, process development, analytics, and manufacturing services for monoclonal antibodies, bispecific antibodies, and fusion proteins.

Woodstock Sterile Solutions

United States

Woodstock Sterile Solutions is a leading CDMO specializing in aseptic pharmaceutical manufacturing of sterile liquid formulations using advanced blow-fill-seal (BFS) technology. Based in Woodstock, Illinois, the company has a decades-long track record in clinical development through full-scale commercial production, with particular expertise in ophthalmic and respiratory products as well as complex solutions, suspensions, and emulsions.

WuXi Biologics

China

WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) for biologics, with over 12,000 employees across the US, Ireland, Germany, China, and Singapore. The company provides end-to-end solutions from discovery through commercial manufacturing for biologics including monoclonal antibodies, bispecifics, ADCs, vaccines, and mRNA products using both mammalian and microbial expression systems.

Xellia Pharmaceuticals

China

Xellia Pharmaceuticals is the global leader in fermentation-based non-beta-lactam anti-infective APIs and finished dosage forms (FDFs). With over 120 years of pharmaceutical manufacturing heritage, they supply APIs and sterile injectables to over 500 pharmaceutical companies across 80 countries. Also operates as a CMO for third-party sterile injectable production.

Yposkesi (an SK pharmteco company)

France

Yposkesi, an SK pharmteco company, is one of Europe's largest Contract Development and Manufacturing Organizations (CDMO) for gene therapy viral vector manufacturing. Based near Paris (Evry-Courcouronnes), the company provides end-to-end gene therapy CDMO services including process development, cGMP manufacturing, analytical testing, and regulatory support for AAV, lentivirus, and other viral vectors.

Zhejiang Ausun Pharmaceutical Co Ltd

China

Zhejiang Ausun Pharmaceutical Co., Ltd., established in 2010 and listed on the Shanghai Stock Exchange (2017), is a Chinese pharmaceutical company based in the Taizhou Bay Economic Development Zone, Zhejiang Province. The company specializes in R&D, production, and sale of formulations (capsules, tablets) and active pharmaceutical ingredients. They are FDA-registered (FEI 3009065969) with 3 FDA inspections (1 NAI, 2 VAI, 0 OAI), have 2 FDA-approved products (capsule and tablet, oral route), hold US DMF filings, and have participated in 1 clinical trial (Infectious Disease). They employ 1,000-4,999 people. Their website was blocked (403 WAF), so details come primarily from search results and FDA regulatory data.

Zydus Lifesciences Ltd

India

Zydus Lifesciences Ltd. (formerly Cadila Healthcare) is a major Indian pharmaceutical company headquartered in Ahmedabad, Gujarat, ranked 4th in the Indian pharma industry with 29,000+ employees globally. In June 2025, Zydus entered the global biologics CDMO business by acquiring Agenus Inc.'s U.S. manufacturing facilities in Emeryville and Berkeley, California for $75M upfront (plus $50M milestones), now operating as independent subsidiary Zylidac Bio LLC. These facilities provide end-to-end biologics development and manufacturing from pre-clinical to commercial stages, including monoclonal antibody manufacturing for Phase-3 immuno-oncology products (Botensilimab and Balstilimab). Zydus has 15 FDA-registered facilities, 156 FDA-approved products across capsules, tablets, creams, gels, injectables (including liposomal), ointments, suppositories, and transdermal patches. They have 58 FDA inspections (25 NAI, 28 VAI, 5 OAI) and 51 recalls (2 Class I, 40 Class II, 9 Class III). Manufacturing sites span Gujarat, Maharashtra, Goa, Himachal Pradesh, Sikkim (India), plus US (Vermont, Pennsylvania, Missouri) and Brazil. Their CDMO services are specifically the biologics arm through Zylidac Bio -- the broader Zydus business is primarily own-brand generic pharmaceuticals.

ACON Pharmaceuticals

United States

ACON Pharmaceuticals Inc is a specialty contract research organization (CRO) based in Cranbury, New Jersey, focused on drug product development. They specialize in drug delivery systems including siRNA, mRNA, liposomes, nanocrystals, and complex generics development via the 505(b)(2) pathway. They are primarily a development-focused CRO, not a manufacturing organization.

Adare Pharma Solutions

Italy

Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end integrated services from product development through commercial manufacturing, focused on oral dosage forms. They specialize in taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. They have developed and manufactured more than 65 products sold in over 100 countries globally.