Regulatory Support CDMOs

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.

Iasis Pharma S.A.

Greece

Iasis Pharma S.A. is a steadily growing Greek pharmaceutical company founded in Athens, engaged in the manufacture and marketing of a wide range of pharmaceutical products across multiple therapeutic areas. The company operates production facilities and offers products including oral solids, injectables, and topicals.

IBSA Institut Biochimique SA

Italy

IBSA (Institut Biochimique SA) is a Swiss multinational pharmaceutical company founded in 1945 in Lugano, with products present in over 90 countries. The company develops and manufactures innovative pharmaceutical products across 10 therapeutic areas with proprietary drug delivery technologies, including oral films, patches, and gonadotropin purification processes. IBSA has FDA-approved products in multiple dosage forms.

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.

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.

JAMP Pharma

Canada

JAMP Pharma Group is a leading Canadian pharmaceutical company with over 35 years in the industry, active across generic drugs (JAMP Pharma), biosimilars (BioJAMP), branded products (Orimed Pharma), natural health products (Wampole/Laboratoire Suisse), and beauty products (Cosmetic Import). The company acquired a pharmaceutical manufacturing facility in Levis, Quebec, and manufactures prescription drugs in Canada through its JAMP Pharma Manufacturing division.

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.

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.

Medichem S.A.

Malta

Medichem S.A. is a family-owned, vertically integrated pharmaceutical company headquartered in Barcelona, Spain, with nearly 50 years of industry experience. The company delivers end-to-end solutions from API development to finished drug product manufacturing (oral and injectable). Their portfolio includes approximately 45 APIs and 20 finished dosage forms (FDF), supported by full regulatory dossiers. Medichem provides API and FDF CDMO solutions and is also a leader in antiseptic products. The company has 400 experienced professionals serving 600+ corporate customers across 60+ countries. Facilities include R&D centres in Barcelona, Celra, and Hal-Far (Malta), and manufacturing plants in Celra (Spain), Hal-Far (Malta), and a new sterile injectables facility in Llanera, Asturias (Medichem Solutions). Medichem also has commercial offices in New York and Nanjing.

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.

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).

NorthStar Medical Radioisotopes, LLC

United States

NorthStar Medical Radioisotopes is a US-based commercial-stage company focused on the development, production, and commercialization of radiopharmaceuticals. Operating a dedicated Radiopharmaceutical CDMO/CMO on its 55-acre Beloit, Wisconsin campus, NorthStar develops novel non-reactor-based production processes for therapeutic and diagnostic radioisotopes including Molybdenum-99, Copper-67, and Actinium-225. The company has 14 FDA-approved products and a 52,000 sq ft purpose-built CDMO facility.

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.

Nucleus RadioPharma

United States

Nucleus RadioPharma is a US-based full-service CDMO dedicated to building clinical and commercial supply chains for targeted radiotherapies (radiopharmaceuticals). The company operates a cGMP-compliant facility in Rochester, MN with expansion sites under construction in Spring House, PA and Mesa, AZ, targeting over 100,000 square feet of purpose-built radiopharmaceutical development and manufacturing space.

Nuvisan

France

Nuvisan is a full-service CRO and CDMO headquartered in France with state-of-the-art laboratories in Germany and France. The company provides integrated drug discovery and development services spanning omics and biomarkers, compound screening, pharmacology, chemistry, preclinical safety, bioanalysis, clinical services (Phase 1 and 2), and CMC services including drug substance and drug product manufacturing, pharmaceutical analytical services, and clinical trial supply management.

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.

Pace® Life Sciences

United States

DUPLICATE ENTRY -- This is the same company as 'Pace Analytical Services LLC (Pace Life Sciences)' (company index 10). Pace Life Sciences is the CDMO/CRO division of Pace Analytical. Same website content, same capabilities. See company index 10 for full profile.

Padagis LLC

United States

Padagis LLC is a U.S.-based generic pharmaceutical company specializing in development and manufacturing of extended topical and specialty pharmaceutical products. Product portfolio includes prescription creams, ointments, gels, foams, sprays, patches, nasal treatments, and suppositories, with a focus on Paragraph IV generic products. Also manufactures naloxone nasal spray (awarded New York State Department of Health contract in 2025). Over 1,300 employees. Offers contract manufacturing, licensing, and joint venture partnerships.

Panacea Biotec Ltd.

India

Panacea Biotec Ltd. is an Indian biotechnology company engaged in research, development, manufacturing, and marketing of branded pharmaceuticals and vaccines. The company has a USFDA-approved manufacturing facility at Baddi and WHO prequalified operations. Panacea Biotec also offers contract manufacturing services for pharmaceuticals and has been involved in COVID-19 vaccine manufacturing agreements. Listed on Indian stock exchanges.

PannonPharma Ltd

Hungary

PannonPharma Ltd is a Hungarian pharmaceutical company based in Pecsvarad, manufacturing pharmaceuticals since 1995. The company produces solid dosage forms (tablets, film-coated tablets, hard gelatin capsules, modified-release tablets), as well as topical products (gels, sprays) and inhalation drops. Products include Diapulmon inhalation drops, Phlogosol antiseptic solution, Ebrimycin antibiotic gel, IRIX spray, and Thaleum allergy eye drops/nasal spray. Offers contract manufacturing services alongside its own product portfolio. GMP certified.

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.

Pell Tech Healthcare Pvt. Ltd.

India

Pelltech Healthcare is a privately owned WHO-GMP approved Indian pharmaceutical company specializing in the manufacture of conventional and modified-release pellets and finished formulations in capsules and tablets. The company has a dedicated state-of-the-art manufacturing facility focused on pellet-based oral solid dosage forms, taking APIs through formulation development to commercial production.

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.

Pen Tsao Chemical Industry Ltd

China

Pen Tsao Chemical Industry Ltd is a back-integrated manufacturer of APIs, advanced pharma intermediates, and oral solid dosage formulations based in Shanghai, China with over 25 years of experience. The company produces 30+ APIs and formulations from two facilities: a multipurpose plant in Baoshan (56 m3 reactor volume, 218 m3 at Jinshan) and a new site in Pinghu with 270 tons API capacity and 70 tons OSD capacity. Pen Tsao was the first WHO pre-qualified supplier of MDR-tuberculosis drugs.

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.

Pharmascience

Canada

Pharmascience is Canada's largest privately-owned pharmaceutical company, a leading manufacturer of generic, branded, and over-the-counter pharmaceuticals. The company has recently expanded its CDMO services with a new commercial business unit, investing over $120 million to expand its sterile injectable manufacturing facility in Candiac, Quebec, aiming to more than triple capacity. Pharmascience's ambition is to become a world leader in the sterile injectable CDMO segment. The company distributes products in over 50 countries and invests approximately $65 million per year in R&D in Canada. The Pendopharm division offers specialty medicines in gastroenterology, orthopedics, and neurology.

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.

Pinnacle Life Science

India

Pinnacle Life Science is a subsidiary of the Aarti Group, founded in 2015, offering pharmaceutical manufacturing and CDMO services. Operates a state-of-the-art US FDA-approved manufacturing plant in Baddi, India. Produces 3 billion tablet units, 300 million capsule units, and 100 million oncology OSD units annually. Supplies products to 150+ partners in 90+ countries. Therapeutic focus on oncology, cardiovascular, anti-infective, and diabetic segments with 80+ finished products.

Porton Advanced Solutions

China

Porton Advanced Solutions is a China-based CRO and CDMO specializing in Advanced Therapy Medicinal Products (ATMPs). They provide end-to-end services from cell banking, process and analytical method development, GMP production, to fill and finish. Their platforms include lentivirus (for CAR-T, TCR-T, CAR-NK), plasmid DNA (supercoiled, linear, LcDNA), mRNA and LNP encapsulation, AAV, and bacterial vectors. They have achieved 18 IND approvals across NMPA (13), FDA (4), and MedSafe (1), with 300+ GMP batches and 200+ GMP IITs batches produced.

Porton Pharma Solutions

China

Porton Pharma Solutions is a global CDMO headquartered in China with over 4,300 employees and operations in the US, Europe (Slovenia), and China. They offer end-to-end services across small molecules, tides (peptides/oligonucleotides), biologics and conjugates (ADCs), and advanced therapy medicinal products. Technical solutions include crystallization, bio catalysis, metal catalysis, flow chemistry, preparative chromatography, milling, and chemical engineering. FDA-registered with 4 FEI numbers for API manufacture, they have 3 FDA inspections with clean outcomes (1 NAI, 2 VAI).

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.

Prime Pharmaceuticals Pvt Ltd.

India

Prime Pharmaceuticals Pvt Ltd. (also known as PRIME PHARMACEUTICALS PVT. LTD) is an Indian R&D-driven CMO and CDMO with significant manufacturing capabilities. IMPORTANT NOTE: The website at primepharmaceuticals.in appears to be a different entity -- an ayurvedic/herbal product brand based in Hissar, India. The actual PRIME PHARMACEUTICALS PVT. LTD. on PharmaSource is a contract manufacturer with FDA-registered facilities (3 FEI numbers), 7 FDA inspections (1 NAI, 6 VAI), 4 Class I recalls, clinical trials in cardiovascular/oncology/ophthalmology, and 3 FDA-approved products (cream, spray, tablet via oral and topical routes). They are listed on CPHI for biosimilars, injectables, and contract manufacturing, and appear at CPHI Frankfurt.