Stability Studies CDMOs

Bioplus Life Sciences Pvt Ltd

India

Bioplus Life Sciences Pvt Ltd is an Indian integrated biopharmaceutical company and CDMO, with 78 years of history operating in 50+ countries. They specialize in contract development and manufacturing of oral dosage forms, APIs, and nutraceutical products. The company is also developing a novel ophthalmology drug (7-MX for pediatric myopia control) through their subsidiary Theialife. Listed as a small molecule API manufacturer on industry databases.

Biose Industrie

France

Biose Industrie is a French CDMO specialized in microbiome therapeutics, established in 1951. They focus on manufacturing Live Biotherapeutic Products (LBPs) and Next-Generation Probiotics (NGPs) for pharmaceutical and consumer health markets. They combine aerobic and anaerobic microbiology expertise with industrial-scale GMP manufacturing. Investing EUR 80 million to expand capacity from 8,000L to 32,000L fermentation volume at their Aurillac site. They offer full CDMO services from process development to GMP drug product manufacturing.

BioTechnique LLC

United States

BioTechnique LLC is a full-service CRDMO based in York County, Pennsylvania, specializing in cytotoxic and therapeutic sterile injectable fill-finish services. The company provides services from investigational/clinical through to final marketed products, handling both small and large batch sizes. BioTechnique operates an FDA-registered facility with capabilities spanning sterile manufacturing, lyophilization, and high-potency compound handling.

BMI Korea

South Korea

BMI Korea is a South Korean CDMO offering contract development and manufacturing services spanning small molecule APIs, oral solid dosage forms, biologics, vaccines, and mRNA products. The company provides integrated services from formulation development through commercial-scale manufacturing with cGMP-compliant facilities.

Boehringer Ingelheim Biopharmaceuticals GmbH (BioXcellence)

Germany

Boehringer Ingelheim BioXcellence is the contract biopharmaceutical manufacturing arm of Boehringer Ingelheim, one of the world's largest pharmaceutical companies. BioXcellence offers end-to-end biologics CDMO services including mammalian cell culture, microbial fermentation, viral vector production, and aseptic fill/finish with extensive FDA, EMA, and PMDA regulatory approvals across multiple global facilities.

Bora Biologics

United States

Bora Biologics is a biologics-focused CDMO based in the United States offering contract development and manufacturing services for monoclonal antibodies, recombinant proteins, and other biologic drug substances and drug products. The company provides end-to-end biologics services from cell line development through cGMP manufacturing, analytical testing, and aseptic fill/finish.

Bora Pharmaceutical

Canada

Bora Pharmaceuticals is a global CDMO headquartered in Canada with manufacturing facilities across North America and Asia. The company offers comprehensive contract development and manufacturing services for oral solid dosages, sterile injectables, topicals, and liquids, serving both clinical and commercial supply needs with FDA and EMA approved facilities.

Boston Institute of Biotechnology (BIB)

United States

Boston Institute of Biotechnology (BIB) is a US-based full-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy services. The company features the world's first ultra-large bioreactor with 30,000L working volume capacity and provides end-to-end services from cell line development through commercial-scale cGMP manufacturing.

Brawn Laboratories Ltd

India

Brawn Laboratories Ltd is an Indian pharmaceutical manufacturer and WHO GMP-certified company that manufactures finished dosage forms including tablets, capsules, liquids, dry syrups, creams, ointments, and eye/ear drops. The company offers R&D and CDMO services alongside its own branded product portfolio, with manufacturing facilities in Faridabad near New Delhi and a presence in over 60 countries.

BSP Pharmaceuticals

Italy

BSP Pharmaceuticals is an Italian CDMO specializing in cytotoxic, ADC (antibody-drug conjugate), and non-cytotoxic sterile injectable manufacturing. The company provides development, clinical, and commercial supply services including API synthesis, ADC conjugation and fill/finish, and oral solid dose manufacturing, with FDA and EMA approved facilities near Rome.

Cadila Pharmaceuticals Ltd

India

Cadila Pharmaceuticals Ltd is one of India's largest privately-held pharmaceutical companies, operating as both a branded generics company and CDMO/CMO. The company covers the entire life science value chain including R&D, API manufacturing, formulations across 45 therapeutic segments, drug discovery, and contract manufacturing services including vaccines.

Cambrex

Canada

Halo Pharmaceuticals, acquired by Cambrex in 2018 for $425 million and later sold to SK Capital Partners in 2023, is a drug product CDMO specializing in oral solids, liquids, creams, sterile and non-sterile ointments, complex formulations, pediatric indications, and controlled substances. The company operates 430,000 square feet of GMP-compliant manufacturing space across Whippany, New Jersey and Montreal, Quebec, serving over 85 clients.

Canton Biologics Co., Ltd.

China

Canton Biologics Co., Ltd. is a biologics CDMO founded by Chinese returnee scientists at Guangzhou International Biological Island. The company provides integrated R&D and manufacturing services for biologics including CMC development, GMP manufacturing up to 2000L, analytical development, and aseptic fill/finish with GMP certifications from China, US, Japan, and Europe.

CARBOGEN AMCIS

CHina

CARBOGEN AMCIS is a leading CDMO offering drug substance and drug product development and manufacturing services from early development through commercialization. Part of the Indian Dishman Carbogen Amcis group, the company has facilities in Switzerland, France, UK, Netherlands, and China, specializing in complex small molecule APIs, ADC payloads, and sterile drug products.

Catalent Pharma Solution

Argentina

Catalent is a leading global CDMO trusted by pharma, biotech, and self-care companies to accelerate the development, manufacturing, and delivery of products that improve lives. With a worldwide network of facilities, advanced technologies, and deep expertise, Catalent provides integrated end-to-end solutions spanning oral dose, biologics, specialty therapies, cell and gene therapy, and clinical supply. The company partners with innovators from early-stage design through commercial manufacturing.

Chime Biologics

China

Chime Biologics is a leading global CDMO focused on biologics and biosimilars, offering end-to-end services from cell line development through drug substance and drug product manufacturing. The company pioneered modular facilities with single-use bioprocessing technology and has partnerships with companies like MedPacto and Polpharma Biologics.

C.O.C. Farmaceutici Srl

Italy

C.O.C. Farmaceutici Srl (Content Group) is an Italian pharmaceutical CDMO specializing in contract development, manufacturing, and filling of liquid, gel, and lyophilized pharmaceuticals, medical devices, and cosmetics. The company operates three production plants in Italy (Sant'Agata Bolognese, Rovereto sul Secchia, and Pomezia) with 500+ employees, generating 108.3 million euros in turnover in 2025, with particular expertise in ophthalmic and respiratory products. The Pomezia facility (Tubilux Pharma) is FDA approved.

Cohance Lifesciences

India

Cohance Lifesciences is a global CDMO platform specializing in small molecule APIs, antibody-drug conjugates (ADCs), and nucleic acid chemistry, serving customers in nearly 60 countries with 80+ molecules in their portfolio. The company operates 20+ manufacturing and R&D facilities across India and the US, with multiple USFDA and EDQM-accredited sites, offering end-to-end solutions from drug discovery through commercialization including high-potent APIs (OEB 4 & 5), oligonucleotides, and finished dosage forms.

Contract Pharmaceuticals Ltd (CPL)

Canada

Contract Pharmaceuticals Limited (CPL) is a Canadian CDMO specializing in non-sterile liquid and semi-solid pharmaceutical products from concept to commercialization. The company offers end-to-end solutions including product development (NDAs, ANDAs, OTCs), commercial manufacturing, filling, packaging, and testing for creams, ointments, gels, lotions, nasal sprays, and liquid formulations. CPL's facilities are FDA and Health Canada registered, and have been inspected by the Japanese Health Authority, with Mutual Recognition Agreements covering the EU and Australia.

CuraTeQ Biologics

India

CuraTeQ Biologics is an EU GMP-certified biopharmaceutical CDMO based in Hyderabad, India, and a subsidiary of Aurobindo Pharma. The company specializes in biosimilar development and manufacturing with a focus on oncology and immunology therapies, including monoclonal antibodies. CuraTeQ has filed multiple biosimilars with EMA and is building CDMO capabilities for contract biologics manufacturing.

Curida

Norway

Curida is a European CDMO headquartered in Oslo, Norway with over 50 years of GMP experience, specializing in biologics and liquid pharmaceutical formulations. The company offers contract development and manufacturing for monoclonal antibodies, nasal sprays, ophthalmic products, and sterile/non-sterile liquids using Blow-Fill-Seal technology. Curida operates multiple GMP-certified sites across Norway serving 40+ global partners.

Cyndea Pharma S.L

Spain

Cyndea Pharma S.L. is a Spanish CMO dedicated to the development and manufacture of generic pharmaceutical products of steroidal origin, women's health therapies, and oncology treatments in tablet and soft gelatin capsule forms. Part of the Cinfa group, the facility occupies 10,236 m2 and employs 276 professionals. The company is FDA-registered and handles specialized formulations including hormonal products.

Egis Pharmaceuticals PLC

Hungary

Egis Pharmaceuticals PLC is a Hungarian generic pharmaceutical company with over 110 years of history, now offering CDMO services through its Egis Pharma Services division. The company operates three production sites in Hungary (two in Budapest, one in Kormend) and manufactures APIs, tablets, injections, and galenic formulations including ointments, suppositories, and syrups. Egis specializes in highly potent API development and manufacturing using organic chemical synthesis on GMP-compliant multi-functional lines for oncology and rheumatic arthritis therapies.

Eirgen Pharma

Ireland

Eirgen Pharma is a leading CDMO headquartered in Waterford, Ireland, specializing in the development and manufacturing of high-potency oral solid dose (OSD) products and softgel capsules for human and companion animal health. The company offers end-to-end services from pharmaceutical development through clinical and commercial manufacturing with integrated packaging. Eirgen's globally-approved facilities feature advanced containment technologies for oncology, hormonal, and cytotoxic therapies.

Emcure Pharmaceuticals Limited

India

Emcure Pharmaceuticals Limited is a leading Indian pharmaceutical company and CDMO founded in 1981, headquartered in Pune, India, with operations spanning over 70 countries. Originally established as a CDMO, Emcure now operates 14 manufacturing facilities (including US FDA-approved sites) producing APIs, oral solid dosage forms, injectables (including liposomal and lyophilized), biotherapeutics, and vaccines. The company specializes in complex generics, chiral molecules, high-potency APIs, and novel drug delivery systems including lipid nanoparticles and long-acting injectables.

Fresenius Kabi iPSUM S.r.l.

Italy

Fresenius Kabi iPSUM S.r.l. is the Italian subsidiary of Fresenius Kabi, a global healthcare company with significant CDMO operations specializing in lifesaving medicines for critically and chronically ill patients. The company has extensive FDA-registered manufacturing facilities with 405 FDA-approved products, and provides contract development and manufacturing services for injectable, infusion, and other sterile pharmaceutical products.

Gland Pharma

Belgium

Gland Pharma is one of the largest generic injectable manufacturing companies globally, established in Hyderabad, India in 1978. The company operates under a B2B/CDMO business model with four cGMP-compliant formulation facilities and four API facilities, supplying products across 60 countries. It focuses on sterile injectables, oncology, and ophthalmics, including complex injectables and 505(b)(2) filings.

Gracure Pharmaceuticals Ltd

India

Gracure Pharmaceuticals Ltd is an Indian pharmaceutical company offering contract development and manufacturing services for finished dosage forms. The company manufactures oral solid dosage forms, liquids, and semi-solid products from WHO GMP and EU GMP-certified facilities, serving regulated and semi-regulated export markets. It provides formulation development, analytical testing, and commercial-scale manufacturing.

HALIX

Netherlands

HALIX is a biologics CDMO based in Leiden, Netherlands, specializing in end-to-end development and GMP manufacturing of viral vectors, vaccines, and recombinant proteins. The company operates a 6,700 square meter cGMP facility at the Leiden Bio Science Park with 10 clean rooms and 7 bioreactors. HALIX successfully manufactured the AstraZeneca COVID-19 vaccine at commercial scale and serves over 75 customers with a 90% retention rate.

Hanmi Pharm. Co. Ltd

South Korea

Hanmi Pharmaceutical is a major South Korean pharmaceutical company providing comprehensive CDMO services across the entire pharmaceutical lifecycle. The company operates through Paltan Smart Plant (producing 6+ billion chemical drug tablets annually), Pyeongtaek Bioplant (FDA-approved biopharmaceutical manufacturing with 12,500L bioreactors), and Hanmi Fine Chemical (API and raw materials including mRNA cap analogs, NTP, and lipids). Hanmi has partnerships with global pharma companies including Lilly, Roche, and Sanofi.

Harman Finochem Ltd

India

Harman Finochem Ltd is an India-based CDMO/CMO specializing in the manufacture and export of Active Pharmaceutical Ingredients, with core competencies in Metformin HCl, Fenofibrate, Divalproex Sodium, and over 45 other APIs. The company also operates a finished dosage form facility with EU GMP approval, capable of producing 2 billion tablets per year.

Health Biotech Limited

India

Health Biotech Limited is an Indian pharmaceutical manufacturer and exporter specializing in finished dosage forms across multiple formats including tablets, capsules, nasal sprays, ointments, creams, and liquid orals. The company serves global markets and provides contract manufacturing services.

Hennig Arzneimittel GmbH & Co. KG

Germany

Hennig Arzneimittel GmbH & Co. KG is a German family-owned pharmaceutical company with over 120 years of experience, based in Floersheim am Main near Frankfurt. The company operates as both a branded pharmaceutical manufacturer and CDMO, specializing in solid dosage forms including sustained-release tablets, pellets, granules, and capsules. Acquired by Italian company Polifarma S.p.A. in January 2025.

Hikma Pharmaceuticals

Algeria

Hikma Pharmaceuticals is a global pharmaceutical company with 29 manufacturing plants across the US, Europe, and MENA, producing injectable, oral, and respiratory medicines. The company offers CMO services and has announced a $1 billion investment by 2030 to expand US manufacturing and R&D capabilities. Hikma has 76 FDA-approved products, produces 500 million injectable units annually, and has maintained zero critical FDA observations in 20+ years.

HIPRA Biotech Services

Spain

HIPRA Biotech Services is the CDMO division of HIPRA, a Spanish biopharmaceutical company with over 50 years of experience in vaccine research, production, and commercialization. The CDMO unit offers comprehensive biologics contract development and manufacturing services across mammalian, avian, and insect cell culture, microbial fermentation (E. coli, yeast), and aseptic fill-and-finish. HIPRA has experience with over 300 biological entities and demonstrated rapid development capability during COVID-19 vaccine production.

Innova Captab Ltd

India

Innova Captab Ltd is the second largest domestic formulations CDMO in India, providing contract development and manufacturing services across tablets, capsules, dry syrups, ointments, liquid orals, and dry powder injections. The company operates five state-of-the-art facilities with nine independent manufacturing blocks in Baddi, Dehradun, Taloja, and Kathua, serving 14 of the top 15 Indian pharmaceutical companies.

Insud Pharma

Argentina

Insud Pharma is a large, diversified Spanish multinational pharmaceutical group with over 45 years of experience, 10,000 professionals, and 20 industrial plants across more than 50 countries. The company operates API manufacturing, oral solid dose, and injectable manufacturing through its CMO division (Chemo CMO), and biologics/biosimilar manufacturing through its biotech unit mAbxience (majority stake sold to Fresenius Kabi in 2022).

Intas Pharmaceuticals

India

Intas Pharmaceuticals is a leading vertically integrated pharmaceutical company headquartered in Ahmedabad, India, with CDMO capabilities spanning API manufacturing through finished formulations. The company operates 14 manufacturing facilities globally (11 in India, plus UK and Mexico), serving 85+ countries with particular strength in oncology, biosimilars, and plasma-derived therapies. Its flagship Pharmez 2 facility can produce over 1 billion solid oral units monthly and 5 million injectable units.

Intravacc

Netherlands

Intravacc is a Netherlands-based vaccine CDMO founded in 2013 with ~200 employees, specializing in vaccine development from discovery through Phase II clinical trials. The company provides cGMP manufacturing of bacterial, viral, conjugate, and oncological vaccines using mammalian and microbial fermentation systems (up to 200L single-use bioreactors), along with comprehensive analytical services and proprietary vaccine platforms including Outer Membrane Vesicle (OMV) technology.

JOINN Biologics

China

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

Laurus Synthesis

India

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

Liof Pharma

Spain

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

Lomapharm GmbH

Germany

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

Lonza

Switzerland

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

Menarini Biotech

Italy

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

Milan Laboratories (India) Pvt. Ltd.

India

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

Minsheng Group Shaoxing Pharmaceutical Co., Ltd.

China

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

MSN Laboratories

India

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