Regulatory Support CDMOs

Laboratorios Farmaceuticos ROVI S.A. is a major Spanish CDMO and pharmaceutical company, one of the leading European contract manufacturers for high-value-added injectable products. Their CDMO division (ROIS) operates three industrial complexes: two for injectables (Madrid and San Sebastian de los Reyes) and one for oral solid forms and packaging (Alcala de Henares). They also have two facilities in Granada for their own products (bemiparin and enoxaparin). ROVI's Madrid injectables plant is approved by EMA, FDA, and regulators in Korea, Brazil, and Gulf States, with ISO 9001, ISO 14001, and OSHAS certifications. They recently acquired a Bristol-Myers Squibb injectable drug product manufacturing site in Phoenix, Arizona for $250 million, expanding their capacity. ROVI provides end-to-end services from development to final product release, including clinical trials, stability studies, and analytical services. They have collaborated with Roche for manufacturing new medicines in development.

Lake Chemicals Pvt Ltd

India

Lake Chemicals Pvt Ltd is an Indian pharmaceutical company based in Bangalore, Karnataka, specializing in the manufacture of Active Pharmaceutical Ingredients (APIs). Operating from an EU GMP-certified facility, the company focuses on pharmaceutical manufacturing and API development with a commitment to greener processes and safety standards. They provide DMF documentation support for regulatory registration and serve global markets. Listed on CPHI Online and PharmaCompass as an API manufacturer.

Laxai

India

LAXAI Life Sciences is an Indian small molecule CRDMO (Contract Research, Development and Manufacturing Organization) headquartered in Hyderabad. Offers end-to-end services spanning discovery (medicinal chemistry, synthetic chemistry, in-vitro/in-vivo biology, DMPK, safety assessment), development (chemical process development, drug product development, analytical development including method development and validation, impurity profiling, forced degradation studies), and manufacturing (preclinical to FIH supplies, late-phase and commercial, tech transfer, process validation, API manufacturing). Also manufactures specialty chemicals. Recently received investment from SIGNET Healthcare Partners. Passed USFDA audit in March 2025 with zero 483 observations.

LOTTE BIOLOGICS

South Korea

LOTTE BIOLOGICS is a global biologics CDMO headquartered in South Korea, offering end-to-end development and cGMP manufacturing services for biological Drug Substance. Operates the Syracuse Bio Campus (New York, USA) with 40,000L capacity and the Songdo Bio Campus (Incheon, South Korea) planned for 120,000L by 2027. Also operates a $100M ADC manufacturing facility.

LTS Lohmann Therapie-Systeme

Germany

LTS Lohmann Therapie-Systeme AG is a leading CDMO specializing in non-invasive drug delivery systems for nearly 40 years. They are platform specialists in Transdermal Therapeutic Systems (TTS), Oral Thin Films (OTF), and Microneedle Array Patches (MAP). Their full-service CDMO offer covers the entire product lifecycle from API evaluation and feasibility through prototyping, clinical trial supply, and commercial-scale manufacturing. They have manufactured transdermal systems for nicotine, nitroglycerin, and hormone patches, as well as platforms for Parkinson's, Alzheimer's, and pain management.

Lundbeck Pharmaceuticals Italy SpA

Italy

Lundbeck Pharmaceuticals Italy SpA is an Italian API manufacturer with 80 years of industry experience, producing Active Pharmaceutical Ingredients including Metoclopramide Hydrochloride. Part of the Lundbeck Group (Denmark), they operate multiple FDA-registered facilities with extensive inspection history. While primarily a proprietary pharma manufacturer (Lundbeck is known for CNS drugs), their Italian operation manufactures APIs and has FDA-approved products across injectable and oral dosage forms. They also have clinical trial activity in CNS/Neurology and Immunology.

Mabion S.A.

Poland

Mabion S.A. is a Polish end-to-end biologics CDMO offering Drug Substance manufacturing, fill/finish, process development, cell line development and banking, and analytical services. Headquartered in central Poland (1.5 hours from Warsaw airport), they position themselves as a European CDMO partner for pharma and biotech companies. Their capabilities span the full biologics lifecycle from gene to vial.

MabPlex International

China

MabPlex International is a China-headquartered CDMO providing comprehensive biomanufacturing services for the global biopharmaceutical and biotechnology industry. They offer innovative CRO and CMO services for biologics, with facilities in China and the USA (MabPlex USA). They are expanding CDMO services and manufacturing capacity to meet global biologics demand, with multiple manufacturing sites.

mAbxience

Spain

mAbxience, a Fresenius entity, is a global CDMO with 14+ years of experience in the development and manufacture of biopharmaceuticals, specializing in biosimilars and monoclonal antibodies. They are FDA-registered with two FEI numbers for analysis and API manufacture. They have partnered with HP to develop AI solutions for optimizing monoclonal antibody and biosimilar production. Their CDMO platform offers tailored solutions with quality, agility, and flexibility in manufacturing.

Macleods Pharmaceuticals Ltd

India

Macleods Pharmaceuticals Ltd is one of India's top 10 pharmaceutical companies, operating as a CDMO for developing, manufacturing, and globally distributing pharmaceutical products. They produce diverse dosage forms including solid orals, liquid orals, topical formulations, injectables, metered dose inhalers, and dry powder inhalers across therapeutic areas including anti-TB, antimalarials, antiretrovirals, antidiabetics, antihypertensives, and antiasthmatics. They have 152 FDA-approved products, WHO prequalified medicines, and manufacturing facilities compliant with UK MHRA, US FDA, TGA, and WHO guidelines. They operate in 100+ countries.

MassBiologics, a division of UMass Chan Medical School, is a US-based biologics CDMO with over 100 years of history driving discoveries to products. The organization develops novel biologics for diseases of public health importance and offers CMO services including bulk drug manufacture of monoclonal antibodies, vectored therapeutics (gene therapy), and aseptic fill finish. The facility includes approximately 25,000 sq ft of cGMP manufacturing space with dedicated aseptic fill finish and bulk drug substance areas. FDA-registered with 3 FEI numbers. Produces the FDA-licensed Td vaccine and has partnerships for gene therapy manufacturing (SparingVision, PTC Therapeutics).

Nanoform Finland Oyj

Finland

Finnish CDMO specializing in proprietary nanoparticle engineering technology to improve drug bioavailability, enable higher drug loading, and unlock alternative delivery routes (subcutaneous, inhaled). Services span from early development through commercial GMP supply for both small molecules and biologics/peptides. Publicly listed (Nanoform Finland Oyj). Focuses on solving formulation challenges for poorly soluble compounds and enabling patient-centric dosage forms.

National Resilience Inc.

Canada

Major North American biomanufacturing CDMO (branded as 'Resilience') focused on complex medicines including large molecule biologics, cell therapies, and aseptic drug product manufacturing. Operates facilities across the US and Canada. Delivers 100+ million vials and pre-filled syringes annually. Secured $825 million in financing to accelerate CDMO strategy. Offers proprietary technology platforms including Sprout Solutions, Auto-T, DAR-T (next-gen CAR-T), and Idea to Clinic services. FDA registered with 7 FEI numbers, 17 inspections.

Naveh Pharma Ltd.

Israel

Israeli pharmaceutical CDMO providing contract development and manufacturing services for solid oral dosage forms, oral liquids, and semi-solid/topical products. Offers formulation development through commercial manufacturing.

Nectar Lifesciences Ltd.

India

Indian pharmaceutical company with vertically integrated API and formulation manufacturing. FDA registered with 2 FEI numbers (operations: ANALYSIS, API, FDF). Offers CDMO services alongside own branded products. Manufactures both APIs (including beta-lactam antibiotics) and finished dosage forms across oral solids, injectables, and lyophilized products.

OLIC (Thailand) Limited is one of the largest toll and contract manufacturers in Southeast Asia for branded pharmaceutical and healthcare products. The company is a subsidiary of Fuji Pharma and serves over 30 multinational companies including most Big Pharma organizations. OLIC's PIC/S-compliant manufacturing facility produces a wide range of dosage forms including sterile liquids, oral solids, semi-solids, and liquids, serving markets in Thailand, Southeast Asia, Japan, Australia, the US, and Europe.

Olive HealthCare is a fully-integrated Indian pharmaceutical company specializing in the development, manufacturing, and marketing of soft gelatin capsule formulations for pharmaceutical, OTC, and dietary supplement products. Operating three state-of-the-art manufacturing units in India, the company provides CDMO services including toll manufacturing and full development for global partners.

PHT International is a full-service Contract Research, Development, and Manufacturing Organization (CRDMO) headquartered in China, providing innovative solutions to leading life science companies. Offers global solutions in contract research and manufacturing to partners within the pharmaceutical, agrochemical, and specialty chemical industries. Includes import/export services and sterile CDMO manufacturing capabilities.

Pii (Pharmaceutics International, Inc.), acquired by Jabil in February 2025, is a US-based CDMO specializing in complex formulations. With over 30 years of experience and 300+ scientists and support staff, Pii handles potent compounds, complex formulations, aseptic injectables, complex oral dosage forms, and high-potency soft gels. Offers phase-appropriate support from early development through commercial manufacturing. Located in Hunt Valley, Maryland. 100% FDA licensed with 5 drug product approvals in 2023.

Polymun Scientific Immunbiologische Forschung GmbH is an Austrian specialist CDMO in biopharmaceuticals and liposomal/lipid nanoparticle (LNP) formulations. Offers contract development and manufacturing from gene to clinical grade material for innovator and biosimilar products. Unique expertise in liposomal drug formulations that protect, transport, and release drugs at target sites. Also maintains R&D projects including liposomal superoxide dismutase, recombinant porcine trypsin, and HIV antibodies/antigens. FDA registered for analysis, API manufacture, and manufacture.

Portrett Pharmaceuticals

United States

Portrett Pharmaceuticals is a U.S.-based cGMP-compliant contract research organization specializing in expedited pharmaceutical laboratory analytical testing for small molecule drugs. They provide testing services for IND submissions, NDA filings, and ANDA submissions with a focus on rapid turnaround times. Their services include assay testing, content uniformity, dissolution, impurities/degradation, stability studies, and method validation. They position themselves as a specialized testing partner for small and mid-size pharmaceutical companies.

QPS (QPS Holdings)

Austria

QPS (QPS Holdings) is a global contract research organization (CRO) headquartered in Austria, providing bioanalysis, preclinical, and clinical research services. The company offers toxicology, pharmacology, DMPK, bioanalysis (800+ assays), PBMCs, central lab services, clinical trial units, and full clinical research support services across multiple therapeutic areas. QPS emphasizes agility, speed, and quality in drug development research but does not manufacture drugs.

Reig Jofre (Laboratorio Reig Jofre, S.A.) is a Spanish pharmaceutical company founded in 1929 that operates both as a pharmaceutical company with its own products and as a CDMO. They have four development and production centres in Europe (two in Toledo, one in Barcelona, one in Sweden) with over 1,100 employees. Their CDMO capabilities include sterile lyophilizates, sterile liquids, non-sterile liquids, and beta-lactam manufacturing. Known for excellence in freeze-drying technology and advanced sterile manufacturing. FDA-registered with manufacturing and analysis operations, though regulatory history shows 3 OAI inspections.

Rho (Rho, Inc.)

United States

Rho, Inc. is a US-based global Contract Research Organization (CRO) specializing in clinical trial management, biostatistics, data management, and regulatory strategy. The company focuses on neurology, psychiatry, respiratory, pain, and immunology therapeutic areas. Rho provides end-in-mind trial design, pharmacovigilance, and regulatory submissions support but does not manufacture drugs.

Ropack Pharma Solutions is a privately held CMO/CDMO based in Montreal, Canada, specializing in solid oral dose contract manufacturing and comprehensive packaging services. With nearly 50 years of experience, the company provides drug development, tech transfer, clinical and commercial manufacturing, and serialized packaging services for solid oral dosage forms.

SK Pharmteco is a leading global CDMO providing drug development and manufacturing services across small molecules, gene therapy, and analytical testing. The company operates cGMP facilities in the United States (240-acre California headquarters in Rancho Cordova, King of Prussia PA), Ireland (Dublin - 60+ years of API production), South Korea, and France. They offer custom API manufacturing including HPAPIs, viral vector manufacturing (lentivirus via LentiSure and AAV via AAVelocity platforms, 230+ batches manufactured, 100+ supporting clinical trials), plasmid DNA manufacturing, and analytical services. Recently invested in expanding peptide development capabilities and opened a new HPAPI testing lab.

Solvias

Germany

Solvias is a global cGMP contract research organization (CRO) founded in 1999 with 800+ employees across 5 locations worldwide. The company provides comprehensive analytical services for small molecules, biologics, and cell and gene therapies, including release testing, stability studies, extractables/leachables testing, and biosafety testing. Solvias also offers API development and manufacturing services for small molecules up to Phase III.

Stelis Biopharma is a leading, fully integrated biopharmaceutical CDMO based in India (Bangalore) with over 30 years of operational excellence. They brand themselves as 'OneSource' -- a multimodal specialty pharma CDMO with end-to-end capabilities across multiple tech platforms and therapeutic modalities. Their capabilities span biologics (microbial and mammalian cell culture, drug substance and drug product), complex sterile injectables (35 approved ANDAs and 19 commercialized drug products in the US), drug-device combinations (20+ automatic/semi-automatic assembly stations for prefilled syringes, pen injectors, autoinjectors), and soft gelatin capsules (2.4 billion per year capacity). They operate 5 state-of-the-art facilities approved by various regulatory bodies. Syngene acquired Stelis Biopharma's Unit 3 plant in Bangalore for biologics manufacturing.

Syneos Health

Canada

Syneos Health is a leading fully integrated biopharmaceutical solutions organization and CRO, formerly known as InVentiv Health / INC Research. The company provides clinical development (full-service and FSP), commercialization, and consulting services. With 40+ years of clinical trial experience, 480+ MDs, and 750+ PhDs, Syneos Health has helped develop or commercialize 96% of novel oncology drugs approved by the FDA in the last five years. The company is NOT a manufacturer -- it provides research, regulatory, and commercial services to biopharma companies.

uBriGene Biosciences Inc is the same entity as uBriGene (duplicate entry, different ID). This is the China-headquartered entity of the same global CRDMO providing one-stop viral vector-based CDMO services for research and clinical applications. Series C+ funding of 150M CNY (~$20M USD). Same website, same capabilities. See uBriGene entry (ID 10a6a05c) for full details.

Zhejiang Langhua Pharmaceutical Co., Ltd. is a comprehensive CDMO subsidiary of Viva Biotech Holdings, specializing in small molecule contract development and manufacturing. Viva Biotech acquired Langhua for RMB 2,560 million ($368M) to build out their CDMO service chain capabilities. Langhua offers CMC development, API synthesis, and formulation services from pre-clinical through commercial scale. They have completed numerous CDMO cases and have a subsidiary Ningbo Nuobai Pharmaceutical for additional capacity. The company is FDA-registered (FEI 3005289386) and has passed an FDA on-site cGMP inspection, with 3 total FDA inspections (1 NAI, 2 VAI, 0 OAI). They market themselves explicitly as a CDMO offering end-to-end services from CMC through API to formulation manufacturing. No website text was available (empty), so classification relies on search results and regulatory data.

Ash-LongChem Technology Limited (Longchem) is a Chinese CDMO specializing in custom synthesis and contract manufacturing of small molecule APIs and advanced intermediates. They offer process development services including asymmetric reduction, chiral resolution, fluorination, Grignard reactions, and cryogenic reactions, with a CDMO regulatory platform and quality assurance.

BSV BioScience GmbH is a German CDMO specializing in biological API manufacturing, providing contract development and manufacturing services for biologics drug substances. The company is FDA-registered for API manufacture and offers process development, analytical services, and cGMP manufacturing for biopharmaceutical clients.

Glatt Pharmaceutical Services is a CDMO division of the Glatt Group that supports pharmaceutical and biotech companies from initial formulation design to commercial-scale manufacturing. The company specializes in oral solid dosage forms using advanced technologies including fluidized bed systems, spray granulation, Wurster coating, hot-melt extrusion, and amorphous solid dispersions for solubility enhancement and modified release.

Grace Custom Pharma (Fine Chemical Manufacturing Services) is a division of W.R. Grace & Co. that provides contract pharmaceutical drug substance manufacturing services for custom APIs, registered starting materials, and intermediates. The company operates cGMP-compliant facilities and specializes in integrated scale-up from R&D through commercial production, emphasizing quality culture and compliance.

Grace Fine Chemical Manufacturing Services is the pharmaceutical CDMO arm of W.R. Grace & Co., providing contract drug substance manufacturing including custom APIs, registered starting materials, and generic APIs. This entity appears to represent the China-based operations of Grace's pharmaceutical fine chemicals division, operating alongside the US facilities in South Haven and Tyrone.

J‑STAR Research, Inc.

United States

J-STAR Research is a contract process R&D and cGMP manufacturing organization (subsidiary of Porton Pharma Solutions) serving the pharmaceutical and biotech industry. Founded 1996, focused on small molecule drug substance and drug product development. Offers process chemistry R&D, crystallization R&D, high potent compound handling, controlled substances, analytical R&D, QC, and drug product formulation. Two NJ-based R&D centers totaling 129,000 SF. FDA registered with API MANUFACTURE operations.

Katwijk Chemie BV

Netherlands

Katwijk Chemie BV is a Netherlands-based pharmaceutical API manufacturer. Website is currently a domain parking page (no active company site), but CPHI listings and pharma databases confirm they manufacture and supply APIs including Sodium Valproate, Deferiprone, Phenytoin, and various intermediates. Listed as a manufacturer on CPHI Online with US DMF filings. FDA registered with 1 FEI number for API manufacture, 5 inspections (2 NAI, 3 VAI). Search results mention a production facility in Nanjing, China. They appear to be a small-to-mid-size API manufacturer, possibly with limited or inactive web presence.

Kekule Pharma Limited

India

Kekule Pharma Limited is a Hyderabad-based API and pharmaceutical intermediates manufacturer in India. Specializes in developing novel (patent non-infringing) processes for API synthesis. Offers custom synthesis, contract manufacturing, scale-up from kgs to tons, impurity synthesis, and regulatory documentation (DMFs in CTD format). Extensive product portfolio including oncology APIs (Capecitabine, Temozolomide, Imatinib, Gefitinib, Bortezomib), CNS (Escitalopram, Citalopram), GI (Pantoprazole, Famotidine), and others. FDA registered with 2 FEI numbers, 3 inspections (3 VAI).

Lachifarma is an Italian CMO/CDMO based in Zollino (Lecce), Italy, offering research, technological development, and pharmaceutical contract manufacturing services. Listed as an EU GMP CMO, it appears in European CDMO landscape analyses alongside companies like Fine Foods, Doppel, and Biofarma. Lachifarma has been involved in vaccine-related contract manufacturing and offers pharmaceutical dose manufacturing services.

Laviana (Laviana Pharma Group) is a Chinese pharmaceutical company offering integrated CDMO and CRO services. Based on search results showing their website in Chinese, they offer one-stop CDMO services covering small molecules, APIs (raw materials), intermediates, innovative drugs, and customized GMP production. They provide preclinical research, drug selection, and CMC services. Limited English-language information available.

Luye Pharma (EU CDMO)

China

Luye Pharma's EU CDMO operation is based in Germany and is among the largest and most respected European manufacturing sites for Matrix Transdermal Therapeutic Systems (TDS). They offer one-stop-shop CDMO services for transdermal patches covering feasibility, formulation, upscaling, clinical trial material supply, analytical services, blending & coating, cutting/packaging, and full-scale manufacturing. They have a dedicated facility for hormone-containing patches and are fully compliant for handling controlled substances.

Lyomark Pharma GmbH

Germany

Lyomark Pharma GmbH is a German CDMO specializing in sterile medicinal products. They organize contract manufacturing based on dossiers they compile and maintain, and offer regulatory services. Through their subsidiary Lyocontract, they operate a state-of-the-art pharmaceutical manufacturing site. They have 39 FDA-approved products across injectable, oral solid, and liquid dosage forms. The company focuses on niche indications for the hospital market with global distribution.

Morgen Pharmaceutical Services (MPhS), operating as Stason Pharmaceuticals, is a US-based CDMO offering end-to-end drug development and manufacturing services. Located in Irvine, California, the facility can produce over 2 billion oral doses per year with batch sizes from 0.5 kg to 600 kg. The company offers API synthesis (through offshore affiliates), formulation development, pre-formulation studies, solid dosage manufacturing (tablets and capsules), high-containment operations for highly potent compounds (OEL < 1 µg/m³), and injectable/liquid manufacturing through a partner facility in Tainan, Taiwan. FDA-registered with 2 FEI numbers and 11 FDA inspections (8 NAI, 3 VAI).

Indian pharmaceutical CDMO specializing in pre-finished formulation intermediates (PFI) and finished dosage forms (FDF). Manufactures oral solids, oral liquids, injectables, ophthalmics, topicals, and inhalation products. Strong focus on pellet technology and nanotechnology-based drug delivery systems. CRAMS (Contract Research and Manufacturing Services) provider.

Nagase & Co., Ltd.

Japan

Japanese conglomerate with a Healthcare & Pharmaceuticals division offering CDMO services including custom peptide API development and manufacturing, organic synthesis, contract manufacturing of liquid medicines, and pharmaceutical ingredient distribution. Core business is much broader (chemicals, polymers, electronics, food), but the pharma division provides genuine contract manufacturing capabilities.

Nanjing Sino Pharmaceutical Ltd.

China

Chinese pharmaceutical company specializing in production, R&D, and export of generic medicines globally. Covers 1,000+ products across antibiotic, antimalarial, analgesic-antipyretic, cardiovascular, respiratory, antiviral/anti-cancer, hormone, and other therapeutic categories. 20+ years of international registration and export experience in dozens of countries. FDA registered with 3 FEI numbers.