Lyophilization CDMOs

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.

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.

Hiral Labs Ltd

India

Hiral Labs Ltd is an Indian pharmaceutical contract manufacturer established in 2000, based near Roorkee, Uttarakhand. The company operates two WHO-GMP and ISO-certified manufacturing sites producing liquid injections, tablets, capsules, ointments, syrups, eye/ear drops, and oncology injections (including lyophilized). Hiral Labs manufactures over 350 formulations on a contractual basis for more than 300 companies across approximately 4,000 brands.

IDT Biologika

Germany

IDT Biologika is a leading global biologics CDMO headquartered in Germany, specializing in end-to-end development and manufacture of viral vaccines, gene and immune therapeutics, and aseptic fill-finish of sterile injectables. Founded in 1921 with over a century of experience in vaccines, the company operates BSL-2 facilities and has completed over 200 development, clinical, and commercial projects. IDT Biologika is a subsidiary of SK bioscience.

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.

JCR Pharmaceuticals

Japan

JCR Pharmaceuticals is a Japanese pharmaceutical company and CDMO founded in 1975, with nearly 50 years of experience in rare disease treatments and orphan drug production. Selected for Japan's Regenerative Medicine CDMO Subsidy Program in 2025, the company is expanding biomanufacturing infrastructure for cell, gene, and regenerative medicine therapies. JCR operates five production sites and has proprietary platforms including JUST-AAV for gene therapy and J-Brain Cargo for blood-brain barrier penetration.

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.

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.

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.

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.

NerPharMa srl (NMS Group)

Italy

NerPharMa is an Italian CDMO (part of NMS Group, acquired by Benta in 2026) specializing in highly potent compounds with strong expertise in oncology. It operates two divisions: Drug Substance (API manufacturing in high containment glove-box suites, 50-250L reactors, 0.5-5 kg batches) and Drug Product (injectable solutions, suspensions, lyophilized products, and oral solid dosage forms including cytotoxic and cytostatic products).

Novartis Contract Manufacturing

Austria

Novartis Contract Manufacturing is the CDMO arm of Novartis, offering fully integrated end-to-end manufacturing solutions across biologics (mammalian up to 15,000L, microbial up to 13,000L), small molecules (API to fill & finish), cell & gene therapy (CAR-T, AAV, LV), xRNA/LNP/pDNA, and comprehensive fill & finish services. The operation spans multiple state-of-the-art facilities across Austria, Switzerland, Slovenia, Belgium, France, Singapore, and the United States, with 107 FDA inspections and 27 FEI registrations.

Novocol Pharma

Canada

Novocol Pharma is a CDMO headquartered in Cambridge, Ontario, Canada, specializing in sterile injectable fill-finish and combination drug product assembly. With over 40 years of experience, the company offers aseptic and terminally sterilized manufacturing from development through commercialization. Novocol Pharma is a Septodont company and has a fill-finish partnership with Moderna for mRNA vaccines.

Novugen Pharma

Malaysia

Novugen Pharma is a Malaysian pharmaceutical company and CDMO subsidiary of UAE-based SciTech International, providing vertically integrated API and finished dosage form development and manufacturing. The company has USFDA-approved facilities including a dedicated oncology manufacturing plant. Novugen achieved zero Form 483 citations from USFDA and holds Halal pharmaceutical certification.

OFD Life Sciences

India

OFD Life Sciences is a division of Oregon Freeze Dry, one of the largest and most experienced lyophilization companies, with over 60 years of freeze-drying expertise. The company provides comprehensive lyophilization services for biopharma, medtech, and consumer health sectors, from development through commercialization. Its proprietary LyoVantage platform supports cycle development and clinical trial and commercial-scale lyophilization.

Orofino Pharmaceuticals Group

Italy

Orofino Pharmaceuticals Group (OPG), headquartered in Rome, Italy, is a group of companies specializing in third-party pharmaceutical manufacturing services. The group includes Biopharma (betalactam finished products), Injectalia (small sterile liquids including hormones, biologicals, heparins, vaccines), K24 Pharmaceuticals (chemical testing, EU release, secondary packaging), and Drug'On Pharma Switzerland (API manufacturing). Focused on sterile injectables and betalactam oral/injectable dosage forms.

PCI Pharma Services

Australia

PCI Pharma Services is a global CDMO providing fully integrated drug development, manufacturing, clinical trial services, and commercial packaging solutions. With over 8,000 employees in 38 GMP facilities worldwide, PCI offers services spanning sterile fill-finish, lyophilization, oral solid dose manufacturing, complex formulations, and advanced drug delivery including drug-device combination products.

PENMIX Co. Ltd.

South Korea

PENMIX is Korea's largest CDMO, fully committed to globalization of the pharmaceutical industry. The company operates dedicated penicillin manufacturing and general injection manufacturing plants with KGMP and FDA registration. PENMIX provides contract manufacturing services for penicillin formulations (tablets, injections) and sterile injectable products including lyophilized vials, liquid vials, ampoules, and pre-filled syringes, with full automation lines conforming to PICS GMP guidelines.

PeptiStar Inc.

Japan

PeptiStar Inc. is a technology-based CDMO established in 2017 in Osaka, Japan, specializing in peptide and oligonucleotide API development and manufacturing. The company was awarded '2025 CDMO of the Year' by Exelixis and is recognized as the largest-class peptide CDMO in Asia. PeptiStar operates two GMP manufacturing buildings with Class 100,000 controlled areas, housing 300L filter reactors and 500L lyophilizers, capable of handling samples from a few milligrams to several dozen kilograms.

Pfizer CentreOne

Belgium

Pfizer CentreOne is a global CDMO embedded within Pfizer, specializing in commercial manufacturing of oral solid doses, sterile injectables, biologics including monoclonal antibodies, and antibody-drug conjugates. It leverages Pfizer's global manufacturing network across six continents with cGMP-compliant sites and over 170 years of pharmaceutical manufacturing expertise, backed by $1B+ annual manufacturing investments.

Pharmaron

China

Pharmaron is a premier life science CRO/CDMO providing comprehensive R&D and manufacturing services across the entire drug discovery to commercialization process. The company serves small molecules, biologics, ADCs, cell & gene therapies, and protein degraders. It offers laboratory services, chemistry/manufacturing/controls (CMC), clinical development, and biologics/CGT manufacturing. Pharmaron acquired a commercial API manufacturing facility in the UK and operates a gene therapy CDMO in Liverpool with a 20-year track record. The company has over 20 years of experience across 7+ facilities in the UK, US, and China.

Pharmathen

Greece

Pharmathen is a Greek research-centred CDMO specializing in complex drug delivery and formulation development. Founded in 1969 and acquired by Partners Group for $1.89 billion, the company operates two state-of-the-art manufacturing facilities: Rodopi (FDA-approved, 15,300 m2, capacity 3.3 billion tablets, 1.2 billion capsules, 175 million blisters, 4 million sterile syringes/vials) and Pallini/Attica (4,000 m2, 800 million tablets/capsules, 1.5 million sterile vials, 6 million ampoules). Pharmathen has also acquired CBL Patras. Key technology platforms include Long Acting Injectables (biodegradable microparticles, nanosuspensions, self-assembled nanogel systems), modified release oral formulations, preservative-free ophthalmic formulations, and solubility/permeability enhancement technologies.

Pierre Fabre (CDMO)

France

Pierre Fabre CDMO is the contract development and manufacturing arm of the Pierre Fabre Group, a French pharmaceutical and dermo-cosmetics company. Offers over 20 years of CDMO services across pharma and non-pharma active ingredients, dry forms, non-sterile liquids, and biologics including monoclonal antibodies and ADCs. Operates R&D site in Toulouse and 3+ industrial sites in France. Expertise spans extraction, chromatographic purification, chemical synthesis, cytotoxic compound production, plant cell culture, and supercritical CO2 technology. Manufactures 2,100 metric tons of plant extracts and 100+ active ingredients annually.

Prahem Laboratories LLP

India

Prahem Laboratories LLP is an Indian pharmaceutical company and sister company of Sneha Medicare Pvt Ltd (established 1985). Based in Mumbai, they operate as a CMO/CDMO with capabilities in development, production, and marketing of specialty medicines, generic medicines, OTC products, and new therapeutic development. Listed on CPHI Online as CMO/CDMO with distributor/import-export and generics/biosimilars manufacturing capabilities. Their business verticals include APIs, finished dosage forms (including oncology and contrast media), and export to LATAM, CIS, and Southeast Asian markets.

Prasfarma

Spain

Prasfarma is a Spanish pharmaceutical company operating as a CMO and CDMO, headquartered in Cerdanyola del Valles (Barcelona) with a manufacturing plant in Manlleu (Barcelona). They are recognized as a reference in the sector for production of oncology (cytostatic) and high potency products. Their product range includes cytostatic oral forms (hard capsules, sachets, film coated and sugar coated tablets), non-cytostatic parenteral forms (vials, ampoules, prefilled syringes), and cytostatic parenteral forms (liquids, lyophilized). Services encompass development, co-development, regulatory affairs, clinical research, production, logistics, and marketing agreements. ISO 14001:2015 certified.

Profacgen

United States

Profacgen is a US-based protein services and biologics CDMO headquartered in Shirley, New York. The company provides custom protein expression, protein analysis, drug development services, and cGMP-compliant biopharmaceutical manufacturing from a 25,000 sq ft GMP and GLP-compliant facility. Profacgen offers end-to-end CDMO support for biologics including feasibility assessment, process development, cGMP manufacturing, and regulatory filing support.

Pyramid Laboratories

United States

Pyramid Laboratories (now Pyramid Pharma Services) is a California-based CDMO established in 1988, specializing in aseptic manufacturing, development, and analytical services for parenteral drugs. The company supports biologics, peptide, and small molecule drugs from pre-clinical development through commercial supply. Pyramid operates a 90,000 sq ft GMP-compliant facility in Costa Mesa, California, and has received investment from Audax Private Equity.

Simtra BioPharma Solutions

Germany

Simtra BioPharma Solutions is a global CDMO focused exclusively on sterile injectable drug products. With over 65 years of expertise, Simtra offers formulation development, lyophilization cycle optimization, technology transfer, analytical services, fill/finish operations, specialized containment, and global regulatory support. They handle cytotoxics, highly potent compounds, biologics, vaccines, small molecules, ADCs, and diluents. They have a strategic alliance with MilliporeSigma for ADC manufacturing. The company has transferred 60+ ADC candidates including six commercial products to their German site.

Stira Pharmaceuticals (Sterile Injectable CDMO)

United States

Stira Pharmaceuticals is a U.S.-based CDMO specializing in the development and cGMP manufacture of complex sterile injectable products, with integrated analytical capabilities. Founded in 2019, the company serves the U.S. market with services spanning small molecules, peptides, oligonucleotides, and biosimilars in formats including vials, syringes, IV bags, and cartridges with batch sizes up to 2,000L.

Symbiosis Pharmaceutical Services

United Kingdom

Symbiosis Pharmaceutical Services is a world-class sterile fill-finish CDMO based in Stirling, UK, specializing in the GMP manufacture of liquid and lyophilized biological and small molecule drug products. The company serves clinical trial and commercial scale with FDA-inspected and MHRA-licensed facilities. Symbiosis has manufactured its first 10,000-vial commercial batch for a cancer immunotherapy currently in Phase III trials. The company handles a full range of biologics including ATMPs, viral vectors, mAbs, ADCs, RNA/peptide therapies, and vaccines.

ten23 health

Switzerland

Swiss CDMO specializing in formulation, analytical and process development, sterile manufacturing (fill and finish), and testing of injectable medicines. First CDMO in the pharmaceutical industry for injectables to be B Corp certified. Operates from Basel and Visp, Switzerland. Opened new VIVA2 facility with expanded sterile manufacturing lines. QC laboratories approved by both Swissmedic/RHI and FDA. Partners with BD on Libertas wearable injector commercialization. Supports biologics, small molecules, and RNA therapeutics.

Thermo Fisher Scientific Inc.

China

One of the world's largest pharmaceutical CDMOs through its Patheon pharma services division. Provides end-to-end pharmaceutical development and manufacturing services for both small molecules and biologics, from API manufacturing through drug product, sterile fill/finish, packaging, and commercial supply. Operates 31+ FDA-registered facilities globally. 158 FDA inspections on record (52 NAI, 104 VAI, 2 OAI). Also provides cell therapy manufacturing solutions (CTS Rotea cell processing system), laboratory informatics, bioprocessing equipment, and reagents. 4 FDA-approved drug products. Revenue >$40B (full company).

Wacker Biotech

Germany

Wacker Biotech is the CDMO division of Wacker Chemie AG, specializing in advanced biologics manufacturing including proteins, plasmid DNA, mRNA, LNP formulations, live microbial products, and vaccines. With over 30 years of experience and five GMP-compliant facilities in Germany, the Netherlands, and the United States, Wacker Biotech offers process development through commercial-scale manufacturing with E. coli-based technology platforms.

WuXi Biologics

China

WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) for biologics, with over 12,000 employees across the US, Ireland, Germany, China, and Singapore. The company provides end-to-end solutions from discovery through commercial manufacturing for biologics including monoclonal antibodies, bispecifics, ADCs, vaccines, and mRNA products using both mammalian and microbial expression systems.

Zydus Lifesciences Ltd

India

Zydus Lifesciences Ltd. (formerly Cadila Healthcare) is a major Indian pharmaceutical company headquartered in Ahmedabad, Gujarat, ranked 4th in the Indian pharma industry with 29,000+ employees globally. In June 2025, Zydus entered the global biologics CDMO business by acquiring Agenus Inc.'s U.S. manufacturing facilities in Emeryville and Berkeley, California for $75M upfront (plus $50M milestones), now operating as independent subsidiary Zylidac Bio LLC. These facilities provide end-to-end biologics development and manufacturing from pre-clinical to commercial stages, including monoclonal antibody manufacturing for Phase-3 immuno-oncology products (Botensilimab and Balstilimab). Zydus has 15 FDA-registered facilities, 156 FDA-approved products across capsules, tablets, creams, gels, injectables (including liposomal), ointments, suppositories, and transdermal patches. They have 58 FDA inspections (25 NAI, 28 VAI, 5 OAI) and 51 recalls (2 Class I, 40 Class II, 9 Class III). Manufacturing sites span Gujarat, Maharashtra, Goa, Himachal Pradesh, Sikkim (India), plus US (Vermont, Pennsylvania, Missouri) and Brazil. Their CDMO services are specifically the biologics arm through Zylidac Bio -- the broader Zydus business is primarily own-brand generic pharmaceuticals.

Afton Scientific

United States

Afton Scientific is a pharmaceutical CDMO with over 20 years of expertise in aseptic manufacturing for biologics and small molecules. The company operates FDA-inspected facilities with a 99.9% on-time delivery rate and is investing in multi-year expansion of sterile fill-finish capabilities, including new technologies for improved efficiency and increased production capacity.

Alcami

United States

Alcami is a US-based CDMO with 45+ years of experience providing integrated drug product manufacturing, laboratory services, and cGMP pharmaceutical storage. The company specializes in sterile fill-finish manufacturing (liquid and lyophilized injectables, prefilled syringes) and oral solid dose, with DEA licensing for controlled substances and EU/Annex 1 compliance.

Argonaut Manufacturing Services

United States

Argonaut Manufacturing Services is a U.S.-based CMO headquartered in Carlsbad, California, specializing in aseptic fill and finish, lyophilization (LyoDose beads, LyoDots, powders, and cakes), in-vitro diagnostics (IVD) and life science kit manufacturing, and drug-device combination products (DDCP). They recently secured $45M in financing to expand their aseptic fill/finish capabilities. They serve pharmaceutical, life science, IVD, and applied markets from small N-of-1 fills to high-scale commercial products.

August Bioservices

United States

August Bioservices is a US-based CDMO headquartered in Nashville, Tennessee, specializing in sterile injectable drug product development and manufacturing. They offer end-to-end services from lab-scale process development through commercial manufacturing, including formulation, analytical method development and validation, sterile filling for vials, syringes, and IV bags using both stainless steel and single-use technology (1L to 4000L), lyophilization, automated visual inspection, assembly, labeling, packaging, and serialization. The company operates fully isolated filling lines and drug-device combination product capabilities.

Avara Pharmaceutical Services

United States

Avara Pharmaceutical Services is an international contract manufacturing organization (CMO) headquartered in Norman, Oklahoma, specializing in commercial-scale drug product manufacturing. Their core capabilities include oral solid dose (including potent compounds and targeted release formulations) with capacity of 1.5 billion doses per year, liquid and lyophilized sterile injectable fill-finish with terminal sterilization and high containment, and integrated packaging with serialization, automated inspection, and specialty packaging. Avara operates former branded pharmaceutical facilities in the US (Norman, Oklahoma and Arecibo, Puerto Rico) and Italy (Liscate), serving 40+ countries. Facilities hold approvals from FDA, DEA, ANVISA, MPA (Sweden), and other international agencies.

Axplora

Germany

Axplora is a global CDMO specializing in API manufacturing, headquartered in Raubling near Munich, Germany. The group comprises Axplora, Novasep CDMO, and Farmabios, with over 2,000 employees across 10 manufacturing sites on three continents serving 900+ customers. Axplora has particular expertise in chromatography-based separations and small molecule manufacturing, with strong positions in oncology (ADC payloads via Novasep's Le Mans site) and GLP-1 receptor agonist manufacturing (EUR 50M investment at Mourenx, France). The company manufactures both specialty API products and provides contract manufacturing services, with capabilities ranging from lab-scale development through large-scale commercial production including anticancer drugs and complex APIs.

BioCina

Australia

BioCina is a global end-to-end biologics CDMO and the only biologics CDMO in Australia approved by the US FDA. Following the merger with NovaCina, the company provides comprehensive biologics CDMO services spanning cell line development, process development, analytical development, GMP manufacturing of biologics drug substance and drug product, and mRNA manufacturing. Operates facilities in Adelaide, Australia with GMP manufacturing capacity up to 1,000L bioreactors.

BioConnection

Netherlands

BioConnection is a contract manufacturing organization (CMO) based in Oss, The Netherlands, specializing in aseptic fill and finish services for sterile drug products. The company offers flexible development and GMP-compliant manufacturing for both innovative and generic biopharmaceutical companies, with capabilities in vials, syringes, and lyophilized products. Partnered with AGC Biologics for drug product services. FDA-registered with 17 inspections (6 NAI, 11 VAI), demonstrating extensive regulatory history.

Biofortuna

United Kingdom

Biofortuna is a specialist contract development and manufacturing organization (CDMO) focused on diagnostic and life science applications. Based in the UK, the company provides assay development, lyophilization (particularly lyophilized reagent beads), dispensing, kitting, labeling, packaging, stability storage, and DNA extraction services. Biofortuna serves life science innovators with end-to-end outsourcing for diagnostics manufacturing. FDA-inspected (1 VAI). Recently tripled lyo bead output with bespoke robotic manufacturing.

Biopharma Group CDMO

United Kingdom

Biopharma Group is a UK-headquartered CDMO specializing in lyophilized (freeze-dried) and liquid pharmaceutical formulations for clinical manufacturing. They offer services from R&D through technical transfer, engineering batches, and clinical manufacturing to Annex 1 GMP standards. The company can handle substances classified up to OEB 6 and also manufactures non-sterile diagnostic formulations. They operate three Category D cleanrooms and a dedicated lyophilization center.

Bioprox SA (Bioprox Cultures / Bioprox Healthcare)

France

Bioprox SA operates two divisions: Bioprox Cultures (lactic acid starter culture production -- lyophilized ferments for dairy industry) and Bioprox Healthcare (probiotics and postbiotics toll manufacturing). With 50+ years of experience, 800+ clients, 120+ employees, and exports to 40+ countries. They offer custom culture development, toll manufacturing of proprietary probiotics/postbiotics, and R&D services. ISO 9001 and FSSC 22000 certified, with Halal and Kosher certifications. They are NOT a pharmaceutical manufacturer -- they produce live microbial cultures and probiotics.

Birgi Mefar Group (BMG)

Turkey

Birgi Mefar Group (BMG) is one of Turkey's leading producers of sterile injectable products, recently acquired by Abu Dhabi-based ADQ. The company provides contract manufacturing services for sterile injectables with manufacturing sites in Turkey. BMG is listed on pharmaceutical CDMO directories and provides fill-finish and sterile manufacturing services.