Sterile Injectable CDMOs

Jiangsu Nhwa Pharmaceutical Co., Ltd.

China

Jiangsu Nhwa Pharmaceutical Co., Ltd. is a leading Chinese pharmaceutical company specializing in CNS (Central Nervous System) drugs, listed on Shenzhen Stock Exchange (002262.SZ) since 2008. Founded in 1978, the company is designated as a national production unit for narcotic and psychotropic drugs. Nhwa operates over 10 automated production lines for tablets, capsules, liquid injectables, and powder injectables, covering over 800 acres. The company serves as a major global CNS drug production and R&D base.

Jiangxi Tianxin Pharmaceutical Co., Ltd.

China

Jiangxi Tianxin Pharmaceutical Co., Ltd. is a Chinese high-tech pharmaceutical company established in 2004, located in Le'anjiang Industrial Zone, Leping, China. The company specializes in manufacturing active pharmaceutical ingredients, particularly vitamins (Vitamin D), and supplies APIs and intermediates for the alimentary tract, metabolism, and infectious disease therapeutic areas. Tianxin has extensive FDA registration with 15 FEI numbers and 2 FDA-approved products.

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.

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.

MERRYMED FARM LLC

Uzbekistan

MERRYMED FARM LLC is an Uzbekistan-based pharmaceutical manufacturer. Based on CPHI listings, the company produces finished dosage forms including heparin solutions for injection, and products in cardiovascular, respiratory, gastrointestinal, and other therapeutic categories. The company appears to be a commercial pharmaceutical manufacturer rather than a full-service CDMO with development capabilities.

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.

Nephron

United States

Nephron Pharmaceuticals is a US-based sterile pharmaceutical manufacturer and 503B outsourcing facility headquartered in West Columbia, South Carolina. The company specializes in generic respiratory medications (inhalation solutions and suspensions) and contract manufacturing of sterile pre-filled medications using blow-fill-seal (BFS) technology, producing over one billion doses annually.

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).

Nobel Ilac Sanayii Ve Ticaret A.S.

Kazakhstan

Nobel Ilac is a Turkish pharmaceutical company founded in 1964, operating in 20+ countries with representative offices and exporting drug substances and drug products to over 50 countries. The company manufactures both APIs and finished dosage forms, with biotechnology as a declared strategic priority. It is listed as a CMO/CDMO on PharmaSource with contract small molecule API manufacturing capabilities.

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.

Novell Pharmaceutical Laboratories

Indonesia

Novell Pharmaceutical Laboratories is one of the largest pharmaceutical companies in Indonesia, manufacturing both oral solid dosage forms (tablets, capsules, powders) and sterile injectable products (liquid and powder). The factory was originally built and operated by a multinational company, and later expanded to Australian TGA standards. The facility features Class A/B/C/D cleanrooms, Bausch & Stroebel filling equipment, Getinge autoclaves, and Lytzen depyrogenation ovens. Novell has 2 FDA-registered FEI numbers, 3 FDA-approved products, and 10 FDA inspections.

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.

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.

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.

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.

Pharmaniaga Manufacturing Berhad

Malaysia

Pharmaniaga Manufacturing Berhad is a Malaysian pharmaceutical manufacturer and CDMO offering contract manufacturing services. The company produces oral solid dosages (7 billion tablets/capsules capacity), liquids (2.9 million bottles), creams (5 million tubes), small volume injectables including ampoules/vials (43 million units), pre-filled syringes and insulin cartridges (25 million units each), and dry syrups. Products include general pharmaceuticals, penicillin, cephalosporin, and OTC products. Facilities are designed to international pharmaceutical engineering guidelines.

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.

Pharmazeutische Fabrik Montavit GmbH

Austria

Pharmazeutische Fabrik Montavit GmbH is an Austrian family-owned pharmaceutical company founded in 1945 in Absam, Tyrol. The company researches, develops, and manufactures pharmaceutical products and medical devices, exporting to over 80 countries. Montavit offers contract manufacturing (Lohnherstellung/Auftragsfertigung) services to other pharmaceutical companies. Dosage forms include tablets, film-coated tablets, dragees, liquids, creams/gels, granulates, suppositories, sterile pre-filled syringes, laminate tubes, sterile blisters, and powders. The company's own product portfolio covers urology, gynecology, allergy, sleep, travel health, and herbal medicines, with the wound care product Acerbine being well-known.

Phlow Corporation

United States

Phlow Corporation is a U.S.-based public-benefit pharmaceutical manufacturer specializing in onshore continuous-flow production of medicines and APIs. The company was awarded a landmark $354 million HHS/ASPR/BARDA contract to manufacture essential medicines in shortage, strengthening America's pharmaceutical supply chain. Phlow has raised $37 million in Series C funding to expand U.S.-based CDMO operations. The company partners with Fresenius Kabi for the first-ever end-to-end U.S. manufacturing of Epinephrine Injection USP, with Antheia for advanced manufacturing technologies, and with USP for pharmaceutical continuous manufacturing. Phlow is driving sustainable cost competitiveness through advanced manufacturing technology including continuous flow chemistry and AI-enhanced analytics.

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.

Pillar5 Pharma Inc.

Canada

Pillar5 Pharma is a Canadian CDMO founded in 2009, specializing in sterile ophthalmic manufacturing and solid dose production. Market leader in Multi-Dose Preservative Free (MDPF) technology in North America. Produces 30 million ophthalmic bottles and 255 million solid dose tablets per year with 210+ employees. Acquired by ANJAC Sante & Beaute and is also a Prestige Consumer Healthcare company. Health Canada approved, holds FDA Drug Establishment Registration. Acquired former Pfizer site in Arnprior, Ontario.

Polpharma / Polpharma API

Kazakhstan

Polpharma is the leader of the Polish pharmaceutical market and one of the leading drug manufacturers in Central and Eastern Europe, with origins dating to 1935. Produces 400 million packages annually across 5 manufacturing plants and 3 R&D centers. The group includes Polpharma API (CDMO/API manufacturing), Polpharma Biologics (state-of-the-art biologic manufacturing including biosimilars and innovative molecules), and Farmaprojects (B2B hub). Has received grants for RNA-based medicines development under the STEP initiative. FDA registered for API manufacture.

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.

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.

Premas Biotech

India

Premas Biotech is an Indian biologics-focused CDMO based in Gurugram, Haryana, with 150+ employees. They specialize in recombinant protein expression and manufacturing across multiple host systems: bacterial (E. coli), yeast (S. cerevisiae, Pichia pastoris), and mammalian (CHO-DG44). They have proprietary technology platforms including D-CRYPT (difficult-to-express proteins), AXTEX-4D (4D cell culture for oncology drug screening), and C-QWENCE (naive human phage scFv antibody library). Services span cell line development, scouting, process development, scale-up and GMP manufacturing, and analytical development with functional assays. They have delivered 650+ proteins with scale-up to 100L+ volumes and capacity to deliver grams to kilograms. Received a Gates Foundation grant for rotavirus vaccine development. Joint venture Oravax Medical (with Oramed Pharmaceuticals) for oral COVID-19 vaccine development using VLP technology.

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.

ProBioGen AG

Germany

ProBioGen AG is a fully integrated CDMO headquartered in Berlin, Germany, specializing in the development and GMP manufacturing of biopharmaceuticals, viral vectors, and vaccines. The company offers cell line development, process development, GMP manufacturing up to 1000L bioreactors, and comprehensive analytical services. ProBioGen leverages proprietary technologies including GlymaxX (ADCC enhancement), DirectedLuck (transposase system), and CHO.RiGHT production systems.

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.

ProMed Pharma

United States

ProMed Pharma is a US-based CDMO specializing in long-acting injectable and implantable dosage forms with nearly 20 years of operational history. The company has mastered polymer-based drug delivery including molding, extrusion, and microencapsulation techniques using silicones, thermoplastics, and biodegradable excipients. ProMed supports projects from early-stage feasibility through commercial manufacturing and has expanded with the acquisition of a 28,000 sq ft facility in Plymouth, Minnesota.

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.

Renaissance Lakewood, LLC

United States

Renaissance Lakewood is a US-based pure-play CDMO specializing in nasal spray and sterile injectable dosage forms. Founded in 1979 (originally Paco Packaging Labs), they have nearly 20 years of nasal spray experience and offer bench-to-shelf services including formulation development, spray characterization, clinical through commercial manufacturing. Recently acquired by LTS Lohmann Therapie-Systeme AG to expand LTS's CDMO capabilities. FDA-registered with manufacturing, analysis, labeling, and packaging operations in Lakewood, NJ. They have invested over $100M in facility improvements over the past five years.

Rentschler Biopharma

Germany

Rentschler Biopharma is a leading global CDMO focused exclusively on biopharmaceuticals, with over 50 years of industry experience. The company contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023, has supported 180+ biotherapeutics, and serves 180+ clients worldwide. It is an independent family-owned company employing approximately 1,400 people.

Sanochemia Pharmazeutika AG

Austria

Sanochemia Pharmazeutika AG is an Austrian pharmaceutical manufacturer specializing in contrast media (MRI and CT), APIs, and finished dosage forms. Located in Neufeld an der Leitha with over 130 years of history, the company produces over 4 million units of sterile injectable contrast media annually and offers CDMO/CMO services for APIs and drug products.

ScinoPharm (scinopharm.com)

China

ScinoPharm Taiwan is a CDMO headquartered in Tainan Science Park, Taiwan, specializing in high-tech oncology APIs, peptide synthesis, and sterile injectable drug products. With FDA-approved facilities and 18 flexible manufacturing lines, ScinoPharm provides end-to-end services from API development through sterile injectable fill/finish, with a strong focus on complex generics and oncology therapeutics.

Senores Group

India

Senores Group (Senores Pharmaceuticals Limited) is an India-based CDMO specializing in complex generic oral solid dosage forms and API manufacturing. The company operates 5 manufacturing facilities including 2 USFDA-approved formulation plants (Atlanta, USA and Gujarat, India) and 2 API/intermediates plants. Senores serves 300+ customers in 49 countries, with particular strength in controlled substances (C2-C5), extended-release, and orally disintegrating tablet formulations.