Method Development & Validation CDMOs

Jerome Stevens Pharmaceuticals, Inc.

United States

Jerome Stevens Pharmaceuticals, Inc. (JSP) is a family-owned pharmaceutical manufacturer based in Bohemia, New York, established in 1979. The company specializes in manufacturing prescription tablet and capsule formulations under cGMP standards. JSP is notable for manufacturing UNITHROID, the first FDA-approved Levothyroxine Sodium product, and also produces Digoxin tablets. The company provides CMO services to partners including Amneal Pharmaceuticals.

JOINN Biologics

China

JOINN Biologics is a full-service biologics CDMO providing end-to-end development and manufacturing services for complex biologics modalities. Led by US-based development and management leadership, the company operates multi-site facilities in Richmond and Sacramento, California, and acquired Lonza's 183,000 sq ft manufacturing facility in Guangzhou, China. JOINN Biologics is integrated with its sister CRO, JOINN Labs, offering a seamless CRO-CDMO platform.

Laurus Synthesis

India

Laurus Synthesis is the CDMO subsidiary of Laurus Labs, a prominent Indian pharmaceutical and biotechnology company. It is a Contract Development and Manufacturing Organization with a solid track record in supporting drug development and commercial API supply. Serves as the US-affiliate of Laurus Labs, with key markets in the US, European Union, and Japan. Offers high-potent drug manufacturing capabilities and comprehensive CDMO services from drug substance development through commercial manufacturing.

Liof Pharma

Spain

Liof Pharma is a European CDMO headquartered in the Basque Country, Spain, specializing in aseptic manufacturing and lyophilization of sterile injectable biologics. With over 15 years of experience, the company provides clinical and commercial manufacturing of biologics drug products including monoclonal antibodies, peptides, proteins, mRNA, AAV viral vectors, and vaccines. The facility operates in compliance with EMA, FDA, ANVISA, and AEMPS regulations.

Lomapharm GmbH

Germany

Lomapharm GmbH is a German pharmaceutical contract manufacturer with 140+ years of experience (since 1878), offering services from development through production and packaging to market release. The company produces solid oral dosage forms (including micro-tablets) and aseptically manufactured sterile dosage forms such as preservative-free eye drops and nasal sprays. Lomapharm was formerly a subsidiary of Daicel Corporation before being transferred to Bionorica SE.

Lonza

Switzerland

Lonza is a pioneer and world leader in the CDMO industry, founded in Switzerland in 1897. The company provides integrated development and manufacturing services across biologics, small molecules, cell and gene therapy, mRNA, and bioconjugates (ADCs/HPAPIs). With over 20,000 employees across five continents, Lonza serves the global pharmaceutical, biotech, and nutrition industries with end-to-end capabilities from early development to commercial-scale manufacturing.

Menarini Biotech

Italy

Menarini Biotech is a CDMO within the Menarini Group, specialized in process development and GMP manufacturing of biopharmaceuticals. Headquartered in the greater Rome area (Pomezia, Italy), the company has over 25 years of experience in biologics development and manufacturing, including monoclonal antibodies. Menarini Biotech provides services from cell line development through commercial-scale GMP production at its Italian pharmaceutical campus.

Milan Laboratories (India) Pvt. Ltd.

India

Milan Laboratories (India) Pvt. Ltd. is an Indian pharmaceutical manufacturer and exporter established in 1976, producing and exporting pharmaceutical formulations from WHO-cGMP compliant facilities. The company has 300+ marketing authorizations across 43+ countries. Milan has 9 FDA-registered FEI numbers, 65 FDA-approved products across multiple dosage forms (tablets, injectables, liposomal injectables, solutions, emulsions, powders), and has received 38 FDA inspections (14 NAI, 19 VAI, 5 OAI). The company has also had 16 Class II recalls. Milan provides regulatory consulting services and dossier preparation in ACTD, CTD, eCTD formats.

Minsheng Group Shaoxing Pharmaceutical Co., Ltd.

China

Minsheng Group Shaoxing Pharmaceutical Co., Ltd. is a Chinese API manufacturer established in 2002, subsidiary of Hangzhou Minsheng Pharmaceutical Holding Group. The company specializes in R&D and production of high-quality APIs for human and veterinary use, as well as intermediates and cell culture products. Over 50% of products are exported to Europe, the US, Japan and other developed countries. FDA-registered for API manufacture with 8 FDA inspections (3 NAI, 5 VAI).

MSN Laboratories

India

MSN Laboratories is a Hyderabad-based major pharmaceutical CDMO with $1.2 billion in revenue. The company operates 15 API facilities and 6 finished dosage form (FDF) facilities across India and the USA (Novadoz Pharmaceuticals). MSN offers CRAMS (Contract Research and Manufacturing Services) with 200+ first-to-market generics and 400+ formulations. Specialized capabilities include cytotoxics, high-potency APIs, peptides, prostaglandins, and biosimilars. FDA-registered with 14 FEI numbers, 31 FDA inspections (16 NAI, 15 VAI — strong track record), and 119 FDA-approved products. Has established an advanced E&L (Extractables and Leachables) Laboratory.

Nephron

United States

Nephron Pharmaceuticals is a US-based sterile pharmaceutical manufacturer and 503B outsourcing facility headquartered in West Columbia, South Carolina. The company specializes in generic respiratory medications (inhalation solutions and suspensions) and contract manufacturing of sterile pre-filled medications using blow-fill-seal (BFS) technology, producing over one billion doses annually.

NerPharMa srl (NMS Group)

Italy

NerPharMa is an Italian CDMO (part of NMS Group, acquired by Benta in 2026) specializing in highly potent compounds with strong expertise in oncology. It operates two divisions: Drug Substance (API manufacturing in high containment glove-box suites, 50-250L reactors, 0.5-5 kg batches) and Drug Product (injectable solutions, suspensions, lyophilized products, and oral solid dosage forms including cytotoxic and cytostatic products).

Novartis Contract Manufacturing

Austria

Novartis Contract Manufacturing is the CDMO arm of Novartis, offering fully integrated end-to-end manufacturing solutions across biologics (mammalian up to 15,000L, microbial up to 13,000L), small molecules (API to fill & finish), cell & gene therapy (CAR-T, AAV, LV), xRNA/LNP/pDNA, and comprehensive fill & finish services. The operation spans multiple state-of-the-art facilities across Austria, Switzerland, Slovenia, Belgium, France, Singapore, and the United States, with 107 FDA inspections and 27 FEI registrations.

Novocol Pharma

Canada

Novocol Pharma is a CDMO headquartered in Cambridge, Ontario, Canada, specializing in sterile injectable fill-finish and combination drug product assembly. With over 40 years of experience, the company offers aseptic and terminally sterilized manufacturing from development through commercialization. Novocol Pharma is a Septodont company and has a fill-finish partnership with Moderna for mRNA vaccines.

Novugen Pharma

Malaysia

Novugen Pharma is a Malaysian pharmaceutical company and CDMO subsidiary of UAE-based SciTech International, providing vertically integrated API and finished dosage form development and manufacturing. The company has USFDA-approved facilities including a dedicated oncology manufacturing plant. Novugen achieved zero Form 483 citations from USFDA and holds Halal pharmaceutical certification.

Nucleus RadioPharma

United States

Nucleus RadioPharma is a US-based full-service CDMO dedicated to building clinical and commercial supply chains for targeted radiotherapies (radiopharmaceuticals). The company operates a cGMP-compliant facility in Rochester, MN with expansion sites under construction in Spring House, PA and Mesa, AZ, targeting over 100,000 square feet of purpose-built radiopharmaceutical development and manufacturing space.

Nuvisan

France

Nuvisan is a full-service CRO and CDMO headquartered in France with state-of-the-art laboratories in Germany and France. The company provides integrated drug discovery and development services spanning omics and biomarkers, compound screening, pharmacology, chemistry, preclinical safety, bioanalysis, clinical services (Phase 1 and 2), and CMC services including drug substance and drug product manufacturing, pharmaceutical analytical services, and clinical trial supply management.

OFD Life Sciences

India

OFD Life Sciences is a division of Oregon Freeze Dry, one of the largest and most experienced lyophilization companies, with over 60 years of freeze-drying expertise. The company provides comprehensive lyophilization services for biopharma, medtech, and consumer health sectors, from development through commercialization. Its proprietary LyoVantage platform supports cycle development and clinical trial and commercial-scale lyophilization.

Pace® Life Sciences

United States

DUPLICATE ENTRY -- This is the same company as 'Pace Analytical Services LLC (Pace Life Sciences)' (company index 10). Pace Life Sciences is the CDMO/CRO division of Pace Analytical. Same website content, same capabilities. See company index 10 for full profile.

PCI Pharma Services

Australia

PCI Pharma Services is a global CDMO providing fully integrated drug development, manufacturing, clinical trial services, and commercial packaging solutions. With over 8,000 employees in 38 GMP facilities worldwide, PCI offers services spanning sterile fill-finish, lyophilization, oral solid dose manufacturing, complex formulations, and advanced drug delivery including drug-device combination products.

Pen Tsao Chemical Industry Ltd

China

Pen Tsao Chemical Industry Ltd is a back-integrated manufacturer of APIs, advanced pharma intermediates, and oral solid dosage formulations based in Shanghai, China with over 25 years of experience. The company produces 30+ APIs and formulations from two facilities: a multipurpose plant in Baoshan (56 m3 reactor volume, 218 m3 at Jinshan) and a new site in Pinghu with 270 tons API capacity and 70 tons OSD capacity. Pen Tsao was the first WHO pre-qualified supplier of MDR-tuberculosis drugs.

PeptiStar Inc.

Japan

PeptiStar Inc. is a technology-based CDMO established in 2017 in Osaka, Japan, specializing in peptide and oligonucleotide API development and manufacturing. The company was awarded '2025 CDMO of the Year' by Exelixis and is recognized as the largest-class peptide CDMO in Asia. PeptiStar operates two GMP manufacturing buildings with Class 100,000 controlled areas, housing 300L filter reactors and 500L lyophilizers, capable of handling samples from a few milligrams to several dozen kilograms.

Pfizer CentreOne

Belgium

Pfizer CentreOne is a global CDMO embedded within Pfizer, specializing in commercial manufacturing of oral solid doses, sterile injectables, biologics including monoclonal antibodies, and antibody-drug conjugates. It leverages Pfizer's global manufacturing network across six continents with cGMP-compliant sites and over 170 years of pharmaceutical manufacturing expertise, backed by $1B+ annual manufacturing investments.

Pharmaron

China

Pharmaron is a premier life science CRO/CDMO providing comprehensive R&D and manufacturing services across the entire drug discovery to commercialization process. The company serves small molecules, biologics, ADCs, cell & gene therapies, and protein degraders. It offers laboratory services, chemistry/manufacturing/controls (CMC), clinical development, and biologics/CGT manufacturing. Pharmaron acquired a commercial API manufacturing facility in the UK and operates a gene therapy CDMO in Liverpool with a 20-year track record. The company has over 20 years of experience across 7+ facilities in the UK, US, and China.

Pharmathen

Greece

Pharmathen is a Greek research-centred CDMO specializing in complex drug delivery and formulation development. Founded in 1969 and acquired by Partners Group for $1.89 billion, the company operates two state-of-the-art manufacturing facilities: Rodopi (FDA-approved, 15,300 m2, capacity 3.3 billion tablets, 1.2 billion capsules, 175 million blisters, 4 million sterile syringes/vials) and Pallini/Attica (4,000 m2, 800 million tablets/capsules, 1.5 million sterile vials, 6 million ampoules). Pharmathen has also acquired CBL Patras. Key technology platforms include Long Acting Injectables (biodegradable microparticles, nanosuspensions, self-assembled nanogel systems), modified release oral formulations, preservative-free ophthalmic formulations, and solubility/permeability enhancement technologies.

Pillar5 Pharma Inc.

Canada

Pillar5 Pharma is a Canadian CDMO founded in 2009, specializing in sterile ophthalmic manufacturing and solid dose production. Market leader in Multi-Dose Preservative Free (MDPF) technology in North America. Produces 30 million ophthalmic bottles and 255 million solid dose tablets per year with 210+ employees. Acquired by ANJAC Sante & Beaute and is also a Prestige Consumer Healthcare company. Health Canada approved, holds FDA Drug Establishment Registration. Acquired former Pfizer site in Arnprior, Ontario.

Porton Advanced Solutions

China

Porton Advanced Solutions is a China-based CRO and CDMO specializing in Advanced Therapy Medicinal Products (ATMPs). They provide end-to-end services from cell banking, process and analytical method development, GMP production, to fill and finish. Their platforms include lentivirus (for CAR-T, TCR-T, CAR-NK), plasmid DNA (supercoiled, linear, LcDNA), mRNA and LNP encapsulation, AAV, and bacterial vectors. They have achieved 18 IND approvals across NMPA (13), FDA (4), and MedSafe (1), with 300+ GMP batches and 200+ GMP IITs batches produced.

Porton Pharma Solutions

China

Porton Pharma Solutions is a global CDMO headquartered in China with over 4,300 employees and operations in the US, Europe (Slovenia), and China. They offer end-to-end services across small molecules, tides (peptides/oligonucleotides), biologics and conjugates (ADCs), and advanced therapy medicinal products. Technical solutions include crystallization, bio catalysis, metal catalysis, flow chemistry, preparative chromatography, milling, and chemical engineering. FDA-registered with 4 FEI numbers for API manufacture, they have 3 FDA inspections with clean outcomes (1 NAI, 2 VAI).

Premas Biotech

India

Premas Biotech is an Indian biologics-focused CDMO based in Gurugram, Haryana, with 150+ employees. They specialize in recombinant protein expression and manufacturing across multiple host systems: bacterial (E. coli), yeast (S. cerevisiae, Pichia pastoris), and mammalian (CHO-DG44). They have proprietary technology platforms including D-CRYPT (difficult-to-express proteins), AXTEX-4D (4D cell culture for oncology drug screening), and C-QWENCE (naive human phage scFv antibody library). Services span cell line development, scouting, process development, scale-up and GMP manufacturing, and analytical development with functional assays. They have delivered 650+ proteins with scale-up to 100L+ volumes and capacity to deliver grams to kilograms. Received a Gates Foundation grant for rotavirus vaccine development. Joint venture Oravax Medical (with Oramed Pharmaceuticals) for oral COVID-19 vaccine development using VLP technology.

ProBioGen AG

Germany

ProBioGen AG is a fully integrated CDMO headquartered in Berlin, Germany, specializing in the development and GMP manufacturing of biopharmaceuticals, viral vectors, and vaccines. The company offers cell line development, process development, GMP manufacturing up to 1000L bioreactors, and comprehensive analytical services. ProBioGen leverages proprietary technologies including GlymaxX (ADCC enhancement), DirectedLuck (transposase system), and CHO.RiGHT production systems.

Profacgen

United States

Profacgen is a US-based protein services and biologics CDMO headquartered in Shirley, New York. The company provides custom protein expression, protein analysis, drug development services, and cGMP-compliant biopharmaceutical manufacturing from a 25,000 sq ft GMP and GLP-compliant facility. Profacgen offers end-to-end CDMO support for biologics including feasibility assessment, process development, cGMP manufacturing, and regulatory filing support.

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.

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.

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.

SMS Pharmaceuticals Ltd

India

SMS Pharmaceuticals Ltd. is a listed Indian pharmaceutical company and global player in API manufacturing, established in 1990. The company operates four multi-product manufacturing facilities and two research centers, employing over 1,000 people and exporting to 75+ countries. SMS has export house status and is expanding CDMO services with a planned Rs 250 crore expansion.

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.

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.

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.

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.