Stability Studies CDMOs

Emil Pharmaceutical Industries Pvt Ltd

India

Emil Pharmaceutical Industries Pvt. Ltd. is an Indian CDMO founded in 1989, headquartered in Mumbai with three manufacturing units in MIDC Tarapur, Maharashtra. The company manufactures pharmaceuticals, nutraceuticals, and OTC formulations including tablets, capsules, powders, liquids, creams, and ointments. Emil has partnered as a CDMO with global companies including Abbott, Mylan, Pfizer, GSK, USV, and MSD, and exports to over 25 countries with certifications from WHO, ISO 9001, NAFDAC Nigeria, and FDA Ghana.

ENABLE Biotech Ltd (Switzerland)

Switzerland

ENABLE Biotech is a Swiss CDMO specializing in cell and gene therapy manufacturing for clinical-stage companies. The company operates from a SwissMedic-accredited GMP facility with Grade C production rooms equipped with Grade A isolators, focusing on phase-appropriate CMC expertise at attractive pricing for first-in-human production.

Enable Innovations S.r.l.

Italy

Enable Innovations is an Italian contract manufacturer specializing in the aseptic preparation and filling of sterile liquid products, particularly eye drops, nasal sprays, and inhalation solutions. Founded in 2009 in Carpi, Italy, the company operates fully automated production lines for medical devices, food supplements, and foods for special medical purposes.

ENCell Co., Ltd.

South Korea

ENCell Co., Ltd. is a South Korean biotechnology company and CDMO specializing in cell and gene therapy, founded in 2018 as a spin-off from Samsung Medical Center. The company operates three separate GMP facilities and provides end-to-end pharmaceutical development services from R&D to regulatory approval, including drug substance/product manufacturing and contract quality testing.

Enzene Biosciences Limited

India

Enzene Biosciences is an Indian CDMO and subsidiary of Alkem Laboratories, specializing in biologics and biosimilar development and manufacturing. The company's patented EnzeneX continuous bioprocess manufacturing platform significantly reduces the cost of producing complex biologics and monoclonal antibodies, with facilities in Pune, India and an expanding site in Hopewell, New Jersey, USA.

Exela Pharma Sciences

United States

Exela Pharma Sciences is a US-based integrated specialty pharmaceutical company and CDMO founded in 2005, specializing in sterile injectable development and manufacturing. The company operates FDA-inspected cGMP facilities in Lenoir, North Carolina, with capacity to produce over 100 million sterilized units annually across liquid vials, IV bags, lyophilized vials, and pre-filled syringes.

Experic

United States

Experic is a US-based CDMO headquartered in Cranbury, NJ, specializing in pharmaceutical development, powder handling, inhalation drug products, and clinical trial supply packaging. The company has expanded its analytical laboratory capabilities and opened a facility in Dublin, Ireland to support global clinical trials.

Forge Biologics (Ajinomoto Group)

United States

Forge Biologics, acquired by Ajinomoto Group in 2023 for $554-620 million, is a gene therapy CDMO specializing in high-purity adeno-associated virus (AAV) vector and plasmid manufacturing. The company operates a 200,000 sq ft Hearth facility in Columbus, Ohio with 20 cGMP suites and 20,000L bioreactor capacity, providing end-to-end services from preclinical process development through commercial manufacturing.

Fortis Life Sciences

United States

Fortis Life Sciences is a CDMO partner to diagnostics and life science companies, offering an integrated portfolio of reagents, components, and service solutions. The company provides antibody development and manufacturing, conjugation services, lyophilization, cell and gene therapy support, and diagnostic assay CDMO services.

Glenmark (incl. API arm Glenmark Life Sciences)

Argentina

Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company focused on branded and generic formulations, with an API manufacturing arm called Glenmark Life Sciences. The company manufactures APIs and finished dosage forms primarily for its own portfolio, spanning dermatology, respiratory, oncology, and cardiovascular therapeutic areas. Glenmark Life Sciences produces over 120 APIs across multiple manufacturing sites in India.

Global Pharma HealthCare (India)

India

Global Pharma HealthCare is an Indian pharmaceutical CDMO offering contract development and manufacturing services for sterile and non-sterile dosage forms. The company provides end-to-end services from formulation development through commercial manufacturing, including oral solids, liquids, sterile injectables, and lyophilized products. It serves regulated markets including the US, EU, and other global markets.

Globela Pharma Pvt Ltd

India

Globela Pharma Pvt Ltd is an Indian pharmaceutical company founded in 2006, offering CDMO, CRAMS, and API manufacturing services. The company has specialized EU GMP-certified facilities for oncology (cytotoxic) and cephalosporin manufacturing, with a DSIR-approved R&D center and exports to over 50 countries. It provides end-to-end services from API and intermediate manufacturing through finished dosage form production.

GP Pharm S.A.

Spain

GP Pharm S.A. is a Spanish CDMO specializing in sterile injectable manufacturing, with particular expertise in long-acting injectable depot formulations including microspheres and sustained-release systems. The company offers contract development and manufacturing services from formulation development through commercial production, with capabilities in aseptic processing, fill/finish for vials and pre-filled syringes, and lyophilization.

Granules (Granules India)

India

Granules India Limited is a vertically integrated pharmaceutical company and CDMO specializing in high-volume oral solid dosage manufacturing from APIs through finished dosage forms. The company is one of the largest manufacturers of core molecules such as paracetamol, metformin, guaifenesin, and ibuprofen, operating multiple FDA- and EU GMP-approved manufacturing facilities across India and the US. It provides contract manufacturing services for global pharmaceutical companies.

hameln rds s.r.o.

Slovakia

hameln rds s.r.o., based in Modra, Slovakia, is a well-recognized pharmaceutical CDMO that has been providing services to the healthcare industry since 1972. The company offers analytical and galenical development of pharmaceuticals, QC and laboratory services (including stability testing, batch release, and biologics testing), GMP production of APIs, and regulatory affairs support. It is FDA-registered with approved injectable products.

Helba İlaç İç ve Dış San. Tic. A.Ş.

Turkey

Helba Pharma is a Turkish pharmaceutical manufacturer established in 2008, with roots in Welfar Pharma founded in Azerbaijan in 1995. The company produces solid and semi-solid form medicines at its GMP-certified production facility with 50 million box manufacturing capacity, and actively exports to CIS countries, Balkans, and Middle Eastern markets.

Helix Biotech, Inc.

United States

Helix Biotech, Inc. is a U.S.-based CDMO specializing in GMP formulation and RNA manufacturing, including DNA, RNA, and LNP (lipid nanoparticle) formulations. The company offers end-to-end services from RNA construct design through its StrandSolve platform to GMP manufacturing via its NOVA IJM nanoparticle formulation platform.

Help S.A. (HELP Pharmaceuticals)

Greece

HELP Pharmaceuticals is a Greek pharmaceutical company founded in 1971, operating an EU-GMP certified production facility in Ioannina, Greece. The company manufactures pharmaceuticals, medical devices, nutraceuticals, and cosmeceuticals across sterile and non-sterile lines, including solid, liquid, and semi-solid dosage forms. HELP serves partners in more than 50 countries and provides clinical manufacturing and packaging services.

Helvetic BioPharma SA

Switzerland

Helvetic BioPharma SA is a Swiss biopharmaceutical company based in Mezzovico, Ticino, specialized in the manufacturing of biological high-value products and active compounds. The company offers CMO bioprocessing services including mammalian cell culture and microbial fermentation. Its product portfolio includes recombinant proteins, hormones, and peptides, with PEGylation capabilities for long-acting molecules.

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.

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.

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.

LABIANA

Spain

LABIANA is a Spanish pharmaceutical group founded in 1958 with over 60 years of history, now listed on BME Growth. They operate as a CDMO serving both human and veterinary pharmaceutical sectors. LABIANA has three EU-GMP manufacturing plants: Labiana Pharmaceuticals in Corbera de Llobregat (Barcelona) for human pharma with sterile liquids, non-sterile liquids, and non-sterile solids; and Labiana Life Sciences in Terrassa (Barcelona) plus Veterinarski Zavod Subotica in Serbia for veterinary products including biologicals (viral, bacterial, and autogenous vaccines). The company is a benchmark in contract manufacturing for sterile forms and also manufactures/distributes Fosfomycin Trometamol under its own brand. Their subsidiary Zoleant Pharmaceuticals handles global marketing of niche alternative brand medicines.

Lannett CDMO

United States

Lannett CDMO is the contract development and manufacturing arm of Lannett Company, a generic pharmaceuticals company. Specializes in oral solid dose (OSD) and liquid formulations, including high-potency compounds and DEA-controlled substances. Operates a 425,000 sq ft cGMP-certified manufacturing facility in Seymour, Indiana with dedicated suites for potent drugs. Capabilities include technology transfers, modified release technology, complex formulations, and reformulation. Has over 100 product families currently in distribution. Acquired by Aurobindo Pharma USA Inc. for $250 million in July 2025. Revenue of $306 million in FY 2025.

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.

Linnea SA

Switzerland

Linnea SA is a Swiss pharmaceutical manufacturer with a 40-year legacy specializing in the production of active pharmaceutical ingredients of botanical origin. The company operates from a GMP-certified facility in Switzerland and is known for producing APIs such as scopolamine butylbromide, vinpocetine, vincamine, 5-HTP, and botanical extracts (ginkgo biloba, red clover, bilberry). Linnea complies with GACP guidelines for raw material sourcing.

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.

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.

Medicair

Greece

Medicair is a privately-owned Greek pharmaceutical company founded in 1998, operating with vertical integration from development and manufacturing to commercialization. The company offers contract manufacturing services for solid, semi-solid, and liquid dosage forms including OTCs and food supplements. Their manufacturing specialization is in pMDI inhalers, external use sprays, foam sprays, unit dose ampoules, semi-solids, and capsules, with a production capacity of 8 million canisters. They invest over 10% of turnover in R&D and have 80+ INNs and 150+ branded generic products. Medicair also offers product development, licensing, and distribution partnerships globally.

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.

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.

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.