Drug Product CDMOs

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.

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).

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.

Kevision Systems

India

Kevision Systems is an Indian company specializing in pharmaceutical track & trace, serialization, and inspection systems. Their products include the Panorama 360 inspection system, online print & inspect systems for cartons and labels/bottles, and KevSecure pharma cloud platform for serialization compliance. They serve the pharmaceutical industry as a technology/equipment vendor, not as a drug manufacturer.

Kuhnil Pharm Co., Ltd. is a South Korean pharmaceutical company headquartered in Seoul with manufacturing facilities in Cheonan. They are a prescription drug-oriented, fully-integrated pharmaceutical company that also provides CMO (contract manufacturing) services, specialized in penicillin and injection formulations. Their facilities include production lines for solid oral doses (tablets, film-coated tablets, capsules, powders), soft gelatin capsules, inhalation products, and sterile injectables (freeze-dried, liquid vials, ampoules). They achieved EU GMP approval in 2022 and have established global GMP systems with LIMS, WMS, and RWS systems.

Laboratorios Argenol, S.L. is a Spanish company with approximately 29 employees, specializing in the production of silver-based Active Pharmaceutical Ingredients (APIs) and specialty chemicals. Their product portfolio includes silver chloride, silver nitrate, silver sulfate, silver citrate, silver sulfadiazine, and colloidal silver solutions for pharmaceutical, cosmetic, and industrial applications. They appear on CPHI Online as a producer of GMP-certified APIs. No website text was available but search results confirm their role as an API manufacturer, not a full CDMO.

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.

PiSA (Grupo PiSA / PiSA Farmaceutica) is a major Mexican pharmaceutical company manufacturing 1,500+ branded medications across 17 specialty lines in 14 production plants strategically located in Mexico. Employs approximately 30,000 workers. PiSA USA serves as the nearshore contract manufacturing arm, offering pharmaceutical and medical device CMO services. Company is a Socially Responsible Enterprise (ESR) for 15 consecutive years. Offers 'Maquila de Productos' (contract manufacturing) as a core service.

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.

Lisapharma S.p.A. is an Italian pharmaceutical company specializing in the contract manufacturing of sterile injectable products, located in Erba (Como), Italy. The company provides sterile fill/finish services for vials, syringes, and cartridges, with capabilities in lyophilization. The website domain lisapharma.com is no longer active, but the company operates from lisapharma.it and is FDA-registered for manufacturing.

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.

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.

Newland Pharmaceutical is a Chinese company located in Changge City, Henan Province, founded in 2005. It is a globally important manufacturer of amoxicillin side-chain intermediates (L-PHPG Base, PTSA, L-PHPG Methyl Ester) and pharmaceutical intermediates. The company is a Henan Province 'Specialized, Refined, Differentiated, and Innovative' enterprise with core technology patents in 8 countries.

Nilogen Oncosystems

United States

Nilogen Oncosystems is a US-based contract research organization (CRO) specializing in 3D cancer models using its patented tumoroid technology for translational immuno-oncology. The company creates 3D cancer models from fresh patient tissue that retain the intact tumor microenvironment (TME), providing preclinical testing services for antibody-based therapeutics, cell therapies, and oncolytic viruses. It does not manufacture drugs.

Noble Life Sciences, Inc.

United States

Noble Life Sciences is a full-service preclinical CRO based in Sykesville, Maryland. The company provides contract research and development, bioanalysis, analytical testing, pharmacodynamic modeling, and preclinical safety testing services across drug, device, and vaccine development. It acquired Spring Valley Laboratories to enhance its preclinical capabilities.

North China Pharmaceutical Group Corp. (NCPC) is one of China's largest pharmaceutical enterprises with multiple GMP manufacturing sites capable of both biological transformations and chemical synthesis. The company specializes in antibiotics, anti-allergy preparations, and antiviral products. NCPC has 3 FDA-registered FEI numbers and 7 FDA inspections (all VAI), indicating substantial but compliance-challenging export operations.

NovaCina is a sterile injectable CDMO based in Perth, Western Australia, launched by Bridgewest Group. The company manufactures sterile injectable drug products for all phases from development through commercial production. NovaCina has expanded its facility with a high-tech SA25 GMP filling line for small-batch sizes and has since merged with BioCina to create an end-to-end CDMO offering integrated biopharmaceutical and small molecule contract manufacturing services.

Novecal

France

Novecal is a French fine chemical company offering CRO services focused on synthetic route design and custom synthesis for APIs, NCEs, and intermediates. The company specializes in organometallic catalysts and ligands (palladium catalysts for cross-coupling reactions, C-H activation), oleochemistry, particle functionalization, and formulation R&D. Novecal produces small batches and provides route scouting and process optimization services but is not a drug manufacturer.

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.

Oman Pharmaceutical Products Co. LLC is a pharmaceutical manufacturer based in Salalah, Oman, engaged in inhouse formulation manufacturing, out-licensing, and CDMO business. The company produces oral solid dosage forms including tablets and offers contract manufacturing services to partners in the region and beyond.

Pharmaceutical Manufacturing Research Services (PMRS) is a U.S.-based cGMP contract manufacturer providing sterile CDMO manufacturing services. Located in Horsham, Pennsylvania, the company specializes in sterile injectable manufacturing and spray drying capabilities.

PHIL Inter Pharma is a CMO/CDMO operating two manufacturing sites in the same industrial park in Vietnam. The company is a soft capsule manufacturer offering CMO/CDMO services from a UK MHRA GMP-accredited facility for pharmaceuticals. PHIL Inter Pharma has 250-499 employees and also manufactures generics/biosimilars. Products include the KOSENA and CALEDO brands. The company has South Korean origins (KR) and a US presence (PHIL Inter Pharma USA). No website data was available for detailed analysis.

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.

Prachi Pharmaceuticals Pvt Ltd, established in 1988, is an Indian GMP-certified manufacturer, supplier, importer, and exporter of Active Pharmaceutical Ingredients, iodine compounds, and specialty chemicals. Based in Mumbai, they have 26-50 employees with annual turnover of INR 25-100 Cr. Their product range includes iodine compounds, triphenyl methane, potassium metaperiodate, chlorhexidine digluconate, camphor quinone, closantel base, L-seleno methionine, and veterinary products. They are listed on PharmaSource and PharmaCompass as an API manufacturer with USDMF filings including furosemide.

PSM GmbH is a German pharmaceutical CDMO specializing in aseptic fill and finish services for drugs, biologics, and biopharmaceutical products. The company offers end-to-end commercial fill and finish services with state-of-the-art flexfill filling-line technology and formulation development capabilities. Limited website data is available, but search results consistently identify PSM as a specialized aseptic fill/finish CDMO.

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.

Rajasthan Antibiotics Ltd. (RAL) is an Indian integrated pharmaceutical company specializing in the manufacture of Active Pharmaceutical Ingredients (APIs), particularly sterile penicillins and injectable APIs. They supply APIs including tazobactam sodium sterile, ketoprofen for injection, and avibactam to global pharmaceutical companies.

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.

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.

Savi Pharmaceutical Joint Stock Company (Savipharm J.S.C, SVP) is a Vietnamese pharmaceutical company founded in 2005 in Ho Chi Minh City. The company operates an oral solid dose factory and provides contract manufacturing of dosage form drugs, franchising, and technology transfer services.

Sovereign Pharmaceuticals, LLC is a U.S.-based CDMO located in Fort Worth, Texas, specializing in small-batch prescription drugs. The company packages both solid and liquid pharmaceutical products and has a high potency pharma suite. Sovereign has over 30 years of expertise and was acquired through bankruptcy proceedings by Alora Pharmaceuticals.

Stabicon Life Sciences Pvt.

India

Stabicon Life Sciences Pvt Ltd is an Indian Contract Research Organization (CRO) established in 2010, based in India. PharmaSource explicitly classifies them as a CRO. They provide support throughout all phases of product development including stability testing, formulation R&D, analytical R&D, microbial analysis, and technology transfer for OTC, nutraceutical, natural, and pharmaceutical products. Their services include analytical method development and validation, reverse engineering, stability programs (ICH), and formulation development using QbD principles. They work with pharma and FMCG companies worldwide. They also have a nutraceutical/dietary supplement and patented augmented absorption technology division. A related entity, Lyrus Life Sciences, is described as a CDMO, but Stabicon itself is primarily a CRO.

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.

Symetal S.A.

Greece

Symetal S.A. is a Greek manufacturer of aluminium foil products, primarily for pharmaceutical packaging applications including blister foil and lacquered foil. The company is part of the ElvalHalcor group and is certified under the Aluminium Stewardship Initiative (ASI) Performance Standard. Symetal supplies packaging materials to the pharmaceutical industry but does not manufacture drugs or drug products.

Syncom Healthcare Ltd is an Indian pharmaceutical manufacturing company headquartered in Indore, Madhya Pradesh, with approximately 235 employees. The company's website domain has been sold, suggesting the company may be defunct or restructured. Search results reference the company as a drug manufacturer that has faced quality issues including a dissolution failure flagged by drug control authorities. Limited verifiable information is available about current operations.