Method Development & Validation CDMOs

Heraeus Precious Metals GmbH & Co. KG

Germany

Heraeus Precious Metals GmbH & Co. KG is the pharmaceutical ingredients division of the Heraeus Group, specializing in the production of generic highly potent active pharmaceutical ingredients (HPAPIs) for cancer treatment. The company is the global market leader for platinum-based active ingredients including cisplatin, carboplatin, and oxaliplatin. In 2021, Heraeus made a multi-million euro investment expanding HPAPI manufacturing capacity in Hanau, Germany.

HERMES PHARMA

Austria

HERMES PHARMA is an Austrian CDMO and the leading expert in developing and manufacturing user-friendly oral dosage forms. A sister company of HERMES Arzneimittel (100+ years of pharmaceutical excellence), HERMES PHARMA offers a one-stop-shop from product design through GMP manufacturing. The company recently announced a 25 million euro investment to expand oral drug production capabilities. Their dosage form portfolio includes effervescent tablets, chewable tablets, orally disintegrating granules, instant drinks, and lozenges.

Hongene Biotech

China

Hongene Biotech is a China-based CDMO specializing in oligonucleotide and mRNA manufacturing services. The company provides custom DNA/RNA synthesis and large-scale oligonucleotide production for pharmaceutical and biotech customers globally.

Hovid Bhd

Malaysia

Hovid Bhd is a Malaysia-based pharmaceutical company with over 80 years of history, operating as both a branded generic producer and contract manufacturer. The company offers a portfolio of over 400 products including generic drugs, OTC supplements, disinfectant solutions, medical devices, and consumer products, with distribution in more than 50 countries.

Hovione

China

Hovione is a specialist integrated CDMO dedicated to helping pharmaceutical customers bring new and off-patent drugs to market. Founded in 1959, the company provides API development and manufacturing, drug product development, and particle engineering services across four GMP manufacturing sites worldwide.

HTL Biotechnology

France

HTL Biotechnology is a French biotech company and world leader in the development and responsible biomanufacturing of pharmaceutical-grade biopolymers, primarily hyaluronic acid (sodium hyaluronate) and polynucleotides (PDRN/PN). The company produces these as raw materials/APIs for pharmaceutical, medical device, and cosmetic applications via fermentation technology.

Iberfar – Industria Farmaceutica, S.A.

Portugal

Iberfar, Industria Farmaceutica, S.A. is a privately owned Portuguese pharmaceutical contract manufacturer founded in 1924. The company specializes in contract manufacturing of solid forms and non-sterile liquid products, including controlled drugs, at its EU cGMP-certified facility near Lisbon.

ICROM S.p.A.

Italy

ICROM S.p.A. is an Italian custom API development and manufacturing company based in Concorezzo (MB), specializing in custom development, custom manufacturing, and APIs for specialty drugs. The company operates under cGMP with inspections by AIFA, USFDA, PMDA, and KFDA, and holds Drug Master Files in all major regulatory markets. ICROM recently acquired Holodiag and has a subsidiary Proxis.

Ion Labs, Inc.

United States

Ion Labs, Inc. is a US-based contract manufacturer of dietary supplements and nutritional products, part of HBI Health & Beauty Innovations (now Ourvita Group). With 40+ years of experience, 300+ employees, and 300,000 sq ft facilities in Largo, Florida, Ion Labs manufactures capsules, gummy vitamins, liquid capsules, cap-in-cap, powders, and tablets. The company recently completed a $30 million gummy production expansion increasing capacity to 50 million gummies per month.

Kemwell Biopharma Private Limited

India

Kemwell Biopharma is one of India's largest biologics CDMOs, providing integrated drug substance and drug product development and manufacturing services from a single site in Bangalore. Established with technological support from a leading German biopharmaceutical company, Kemwell serves global pharma and biotech organizations with capabilities spanning monoclonal antibodies, complex fusion proteins, recombinant proteins, and bispecific antibodies. The company has received U.S. FDA approval for commercial drug product manufacturing and operates hybrid biomanufacturing with both stainless steel and single-use bioreactor systems.

Kincell Bio

United States

Kincell Bio is a specialized cell therapy CDMO based in the United States, dedicated exclusively to advancing autologous and allogeneic cell therapies from early clinical supply through pivotal and commercial launch. They provide process development, analytical development, and cGMP manufacturing services. The company operates manufacturing facilities in Research Triangle Park, North Carolina (32,800 sq ft acquired in 2024) and Gainesville, Florida. They have a strategic collaboration with Duke University School for cell and gene therapy innovation, and a partnership with RegCell to advance Treg cell therapies for autoimmune diseases.

Kindeva Drug Delivery

United Kingdom

Kindeva Drug Delivery is a leading global drug-device combination CDMO specializing in sterile injectables, pulmonary and nasal inhalation, and dermal/transdermal drug delivery platforms. The company has a history spanning back to 1956 when it invented the pressurized metered-dose inhaler (pMDI). Kindeva operates a global network of 10 manufacturing and R&D sites including a 155,000+ sq ft dedicated aseptic operations facility in Bridgeton. They hold 12 FDA-approved products across aerosol, metered-dose, film, and extended release dosage forms. Their FDA record shows 38 inspections (9 NAI, 22 VAI, 7 OAI) and 6 FEI-registered facilities covering analysis, manufacture, and sterilization.

KinOmega Biopharm Inc.

China

KinOmega Biopharm Inc. is a leading Chinese manufacturer of Omega-3 fish oil EPA/DHA, producing both pharmaceutical-grade (API) and nutraceutical-grade products. They hold 9 DMFs, 4 GMP approvals (US FDA, Korean FDA, Japan PMDA), and CEP/COS certification for pharmaceutical-grade purity. Their FDA-registered facility (FEI 3009754809) has been inspected with 0 observations. KinOmega uses proprietary 3-times molecular distillation purification with 11-stage SPD technology. They also operate a softgel production line (4 million capsules/day). This is an API and ingredient manufacturer, not a contract drug product CDMO. Their products meet Ph. Eur. and USP standards.

Landmark Bio

United States

Landmark Bio is a cell and gene therapy CDMO based in Watertown, MA, focused on the development and manufacturing of advanced therapies. Offers end-to-end services including process and analytical development, formulation development, cGMP manufacturing, fill/finish, quality control testing, CMC consulting, and IND-enabling services. Acquired by Artis BioSolutions (a new genetic medicines CDMO) to form a comprehensive advanced therapy manufacturing platform. Facility is a 44,000 sq ft full-spectrum manufacturing site.

Lichtenheldt GmbH

Germany

Lichtenheldt GmbH is a German pharmaceutical contract manufacturer (CDMO) specializing in non-sterile liquid and semi-solid dosage forms since 1745. The company produces prescription drugs (Rx), OTC products, homeopathic medicines, disinfectants, dietary supplements, and cosmetics. It serves over 50 customers from small to large pharmaceutical companies.

Lifecore Biomedical

United States

Lifecore Biomedical (Nasdaq: LFCR) is a fully integrated CDMO headquartered in Chaska, Minnesota, specializing in sterile injectable drug product development and manufacturing. The company has over 40 years of experience in aseptic fill/finish, with particular expertise in highly viscous formulations. Lifecore is also a premium producer of non-animal-sourced sodium hyaluronate.

Losan Pharma GmbH

Germany

Losan Pharma GmbH is a German full-service CDMO with 30 years of experience in the development and manufacturing of medicinal products, including solids, semi-solids, and liquids. The company's products are distributed in over 70 countries. Losan Pharma has been successfully inspected by the US FDA, ANVISA (Brazil), Saudi FDA, and Turkish authorities. The company specializes in improving API performance through enhanced bioavailability, stability, and customized release profiles.

Made Scientific

United States

Made Scientific is a US-based cell therapy CDMO specializing in development and GMP manufacturing of cell-based therapies including T cells, NK cells, HSCs, MSCs, iPSCs, and TILs. The company provides services from pre-clinical support through Phase I-III clinical trials and commercial enablement, including process and analytical development, GMP cell banking, drug product manufacture, aseptic fill and finish, and QC lot release and stability testing. FDA-registered with FEI number and operations including API manufacture, analysis, labeling, manufacturing, and packaging.

Magle Chemoswed AB

Sweden

Magle Chemoswed AB is a Swedish CDMO serving pharmaceutical and medical device companies with comprehensive services from development through manufacturing on a contract basis. The company operates a full cGMP and ISO 13485 production site in Malmo with five dedicated manufacturing suites. Services include analytical development, process development, solid state characterization, freeze drying (lyophilization), small-scale vial fill and finish, and inhalation drug product development. FDA inspected (3 inspections: 1 NAI, 2 VAI).

Maharshi Pharma Chem Pvt Ltd

India

Maharshi Pharma Chem Pvt Ltd is an Indian API manufacturer specializing in corticosteroid APIs since 2014. The company manufactures APIs to cGMP standards with expertise in developing corticosteroids for pharmaceutical companies producing topical, inhaled, and injectable formulations. Products include Betamethasone, Dutasteride, and other corticosteroid intermediates. The company operates from Ahmedabad, India.

Malladi Drugs & Pharmaceuticals Ltd

India

Malladi Drugs & Pharmaceuticals Ltd is a leading Indian API manufacturer founded in 1980, specializing in Ephedrine and Pseudoephedrine salts. The company exports APIs to over 60 countries and operates three FDA-registered facilities (3 FEI numbers). FDA inspection history shows 11 inspections (2 NAI, 8 VAI, 1 OAI) with latest in 2025. The company manufactures controlled substance APIs under strict regulatory oversight.

Matica Biotechnology

United States

Matica Biotechnology is a US-based viral vector and gene therapy CDMO that leverages advanced technologies at its purpose-built cGMP facility. The company specializes in viral vector manufacturing from development to commercialization with expertise in process development, assay development, and cGMP manufacturing. Matica Bio operates across five sites worldwide and offers proprietary technologies including MatiMax cell lines, in-line process monitoring, and single-use technologies for AAV, lentivirus, and other viral vector platforms.

Matrix Pharma Corp. Private Ltd. (CDMO BU)

India

Matrix Pharma Corp. Private Ltd. (CDMO BU) is a leading Indian integrated API manufacturer and CDMO specializing in active pharmaceutical ingredients with particular expertise in complex molecules, high-potency drugs, and APIs across therapeutic areas including antiretrovirals, antivirals, antihypertensives, cardiovascular, and CNS therapies. The company operates six state-of-the-art manufacturing facilities with over 3,850 kL installed capacity, including dedicated units for ARVs, peptides, and iron complexes. FDA-registered with 5 FEI numbers and extensive inspection history (25 inspections: 9 NAI, 15 VAI, 1 OAI). Recently inaugurated an oncology manufacturing facility in Vizag.

MedPharm

United Kingdom

MedPharm is a UK-headquartered CDMO specializing in topical, transdermal, and transepithelial drug product development and manufacturing. Founded in 1999, MedPharm offers end-to-end services from early-stage formulation development through clinical supply to commercial manufacturing. Their 110,000 sq ft purpose-built facility in Durham, NC has successfully passed US FDA inspection for commercial manufacture. Services include formulation development, analytical and bioanalytical method development, clinical trial manufacturing, registration batches (PPQ & validation), commercial manufacturing, high potency product manufacturing, filling/packaging/serialization, and specialized in-vitro testing (IVPT, IVRT, skin permeation, nail permeation, RHE testing). MedPharm covers routes of delivery including dermal, gastrointestinal, mucosal, ophthalmic, otic, respiratory, ungual, and vaginal.

metabion

Germany

metabion is a German company and global leader in high-throughput custom oligonucleotide manufacturing, headquartered in Kirchheim near Munich. The company produces custom DNA and RNA products for scientific research, diagnostics, and therapeutic applications. metabion has expanded into therapeutic oligonucleotide manufacturing and partnered with BioSpring for CDMO services. The company is conducting a multi-million euro capacity expansion for both diagnostic and therapeutic oligonucleotides.

Micro-Sphere SA

Switzerland

Micro-Sphere SA is a Swiss pharmaceutical CDMO based in Ticino, Switzerland, specializing in spray drying, capsule filling, and a wide range of R&D services. The company has a 100% regulatory track record, has served over 200 clients from all continents, and worked with over 500 drug substances and drug products. Micro-Sphere operates ISO 8 clean rooms and is FDA-registered for manufacturing. The company has a partnership with Sferalp and provides spray drying of both aqueous and organic solutions.

Mikart, LLC

United States

Duplicate entry for Mikart, LLC -- same company as entries 16 and 17 (companyId a06bcecd and a06f4f1f). This is the same CDMO specializing in oral solid and non-sterile oral liquid dosage forms, headquartered in Atlanta, Georgia with 50+ years of experience, an FDA-registered facility, 82 approved products, and specialization in pediatric, geriatric, and controlled-substance formulations.

Miltenyi Bioindustries (Miltenyi Biotec)

Germany

Miltenyi Bioindustries (part of the Miltenyi Biotec group) is a German CDMO specializing in cell and gene therapy manufacturing. The company offers comprehensive CGT services including cell therapy process development, cell and gene therapy manufacturing, lentiviral vector production, and manufacturing technology platforms. Miltenyi has pioneered partnerships in cell and gene therapies for over 30 years and operates a global manufacturing network. The company has 2 FDA inspections on record and has conducted clinical trials in immunology and oncology.

Minakem (Minafin Group)

Belgium

Minakem, part of the Minafin Group, is a pharmaceutical CDMO with over 60 years of legacy in API development and manufacturing, headquartered in Belgium with production facilities in France, Belgium, and Canada. The company specializes in custom small molecule API and HPAPI development and manufacturing, with over 500m3 total reactor capacity. Minakem has 5 FDA-registered facilities performing API manufacture and analysis, has completed 19 FDA inspections (7 NAI, 12 VAI, 0 OAI), and recently expanded its API portfolio with 5 additional DMF holdings. The company also offers human and animal health APIs including Estradiol, Trenbolone, Fluvastatin, and Fulvestrant with an innovative Gen2 process reducing CO2 footprint.

Minaris Advanced Therapies

United States

Minaris Advanced Therapies (formerly Hitachi Chemical Advanced Therapeutics Solutions) is a global cell and gene therapy CDMO with 25+ years of autologous expertise. The company provides end-to-end GMP manufacturing and advanced testing services for gene-edited autologous (CAR-T, TCR-T), allogeneic (NK, HSC, iPSC), non-edited cell therapies, and vaccines. FDA-registered manufacturing site with FEI number.

Morepen Laboratories Limited

India

Morepen Laboratories Limited is an Indian pharmaceutical company with 40+ years of expertise in API and formulation manufacturing. The company has recently secured an INR 825 crore (approx. USD 100M) multi-year global CDMO mandate, marking a significant expansion into contract manufacturing. Morepen operates a scientifically integrated complex in Baddi with 10 dedicated manufacturing plants. The company exports to 80+ countries and holds FDA, WHO GMP, and EU GMP certifications. Known for the consumer brand Dr. Morepen (home health devices).

NextPharma

Finland

NextPharma is a European pharmaceutical CDMO headquartered in Finland with 10 manufacturing sites across Europe. The company provides pharmaceutical development, clinical trial supply, commercial manufacturing, packaging, and analytical services across a wide range of dosage forms including solids, semi-solids, liquids, softgel capsules, ophthalmics, modified release products, and specialist areas such as hormones, cephalosporins, penicillins, and narcotics.

Nifty Labs Pvt. Ltd.

India

Nifty Labs Pvt. Ltd. is an Indian API and advanced intermediate manufacturer based in Hyderabad, established in 2005. The company operates USFDA, EU GMP, KFDA, and PMDA-approved manufacturing facilities. Through its wholly-owned subsidiary Nifty Pharma, it also manufactures semi-finished dosage forms (pellets with various release profiles). The facility has four production blocks with process equipment handling 0.1L to 7kL batch sizes.

Nippon Shokubai Co., Ltd. (Health & Medical Business)

Japan

Nippon Shokubai's Health & Medical Business division operates as a CDMO specializing in oligonucleotide and peptide API manufacturing. The company has two oligonucleotide synthesis/purification lines and one peptide line, making it one of Japan's largest manufacturers in this sector. A tenfold GMP capacity expansion (several kg/batch) is planned for 2027 to meet growing global demand for nucleic acid drug APIs.

NJ Bio, Inc.

India

NJ Bio, Inc. is a premier CRO/CDMO specializing in antibody-drug conjugates (ADCs), antibody-oligonucleotide conjugates, and related bioconjugation chemistry. The company provides integrated chemistry services from discovery through GMP manufacturing, including custom synthesis of payloads, linkers, drug-linkers, and bioconjugation. NJ Bio has facilities in Princeton, New Jersey with specialized laboratories for high-potency API handling.

Northway Biotech

Lithuania

Northway Biotech is a global end-to-end biologics CDMO specializing in protein-based biologics and gene therapies. The company operates state-of-the-art facilities in Vilnius, Lithuania (EU) and Waltham, Massachusetts (US), with 20+ years of technical expertise. Northway offers cell line development, process development, analytical development, and cGMP manufacturing of drug substances and drug products using both mammalian cell culture and microbial fermentation technologies.

NorthX Biologics

Sweden

NorthX Biologics is a Swedish CDMO specializing in advanced biologics and ATMPs (Advanced Therapy Medicinal Products). The company offers end-to-end services from process development to GMP manufacturing for recombinant proteins, viral vectors, plasmid DNA, cell therapy, extracellular vesicles, and mRNA. Recognized by the Swedish Government as an international competence center and innovation hub in 2021, NorthX has 30+ years of GMP manufacturing experience.

Numaferm GmbH

Germany

Numaferm GmbH is a German biotech company specializing in the biochemical production of peptides and proteins using its proprietary Numaswitch and Numatech expression platforms. The company offers contract development and manufacturing services from discovery through commercial/GMP supply, partnering with established CMOs for large-scale production. Numaferm has completed over 200 successful peptide projects and is ISO 9001:2015 certified.

OBiO Tech (OBiO Technology)

China

OBiO Technology (Shanghai) Corp., Ltd (688238.SH) is a China-based biotechnology company and CRO/CDMO group focusing on cell and gene therapy. The company provides end-to-end offerings including process development, analytical method development, IND-enabling CMC, and clinical and commercial contract manufacturing of viral vectors, oncolytic viruses, and cell therapy products. OBiO operates a 10,000-square-meter GMP campus (Intelli-M PINE Site) with 29 GMP production lines.

Ofichem Group

Netherlands

Ofichem Group is a family-owned European CDMO and pharmaceutical supplier founded in 1975, headquartered in Ter Apel, Netherlands. The company provides end-to-end services from drug substance (API) development through finished drug product manufacturing, including sourcing and distribution. Ofichem has recently expanded through acquisitions of Meribel Pharma Solutions' Uppsala site (early-phase development, ADCs, oligonucleotides, PROTACs) and Avivia (formulation development).

OmniaBio Inc

Canada

OmniaBio Inc is Canada's largest cell and gene therapy CDMO, established by CCRM in 2022. The company provides end-to-end contract development and manufacturing services for autologous and allogeneic cell therapies, lentiviral vectors, and immunotherapies. Its Hamilton, Ontario facility integrates AI, automation, and robotics to enhance manufacturing efficiency and reduce costs.

OneSource Specialty Pharma Limited

India

OneSource Specialty Pharma Limited (formerly Stelis Biopharma Limited) is India's first specialty pharma pure-play CDMO, offering multimodal end-to-end capabilities across drug-device combinations, complex sterile injectables, biologics, and soft gelatin capsules. The company operates five state-of-the-art facilities in Bengaluru with 35 approved ANDAs and 19 commercialized drug products in the US market.

Orchev Pharma Pvt Ltd

India

Orchev Pharma Pvt. Ltd., established in 1989 in Gujarat, India, is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates specializing in Ranitidine HCl, Famotidine, Telmisartan, and Levetiracetam. The facility is US-FDA, EU-GMP (AEMPS), WHO-GMP, KFDA, and COFEPRIS certified. USFDA inspection in 2018 was cleared with zero 483 observations.

Oxford Biomedica (OXB)

United Kingdom

Oxford Biomedica (OXB) is a global, quality- and innovation-led CDMO specializing in viral vector development and manufacturing for cell and gene therapy. With 25+ years of experience, OXB is the first and currently only FDA-approved CDMO for commercial production of lentiviral vectors for CAR-T therapy. The company operates GMP suites across three countries with extensive end-to-end capabilities in lentivirus, AAV, and adenovirus vectors.

Pagari PharmaTech, INC.

India

Pagari PharmaTech, INC. is a U.S.-based CDMO offering concept-to-commercialization services including Research and Development, Analytical Services, Technology Transfer, and Manufacturing Services for Solid and Liquid Oral Dosage Forms as well as OTC and Prescription (Rx) Drug Products. The company adheres to FDA, EMA, and ICH guidelines with support for IND, NDA, ANDA, and 505(b)(2) submissions. Small company (2-10 employees per LinkedIn), based in India with U.S. manufacturing services.

PharmaBlock Group

China

PharmaBlock Group is the parent entity of PharmaBlock (Stock code: 300725.SZSE), a leading CRDMO with 2,300 employees and 700+ global partners across 7 sites. The group provides building blocks, chemistry research, drug substance CDMO, and drug product CDMO services. It holds an EcoVadis Silver Medal for sustainability. Note: this is the same company as PharmaBlock (duplicate entry).

piCHEM (The Peptide Company)

Austria

piCHEM is a privately owned Austrian company with over three decades of experience in the manufacturing of synthetic peptides and peptide-related molecules. Provides full GMP service for peptides used as active pharmaceutical ingredients (APIs), including process scale-up, process validation, analytical services, stability studies, and regulatory support. Also manufactures peptide precursors for radiopharmaceuticals/nuclear medicine. Offers aseptic fill & finish services in-house or through qualified partners. EU-GMP/cGMP certified, FDA registered for API manufacture.

PLD Pharma Services

United States

PLD Pharma Services (formerly Avema Pharma Solutions) is the CDMO division of PL Developments, providing development, manufacturing, and packaging for liquid and solid dose delivery systems based on small molecule APIs. Over three decades of expertise spanning OTC, Rx, diagnostics, and dietary supplements. Offers formulation development, method development & validation, regulatory expertise, and packaging. Recently expanded into pharmaceutical-grade gummy manufacturing in Copaigue, NY.