Sterile Injectable CDMOs

Laboratorios Farmaceuticos ROVI S.A. is a major Spanish CDMO and pharmaceutical company, one of the leading European contract manufacturers for high-value-added injectable products. Their CDMO division (ROIS) operates three industrial complexes: two for injectables (Madrid and San Sebastian de los Reyes) and one for oral solid forms and packaging (Alcala de Henares). They also have two facilities in Granada for their own products (bemiparin and enoxaparin). ROVI's Madrid injectables plant is approved by EMA, FDA, and regulators in Korea, Brazil, and Gulf States, with ISO 9001, ISO 14001, and OSHAS certifications. They recently acquired a Bristol-Myers Squibb injectable drug product manufacturing site in Phoenix, Arizona for $250 million, expanding their capacity. ROVI provides end-to-end services from development to final product release, including clinical trials, stability studies, and analytical services. They have collaborated with Roche for manufacturing new medicines in development.

PiSA (Grupo PiSA / PiSA Farmaceutica) is a major Mexican pharmaceutical company manufacturing 1,500+ branded medications across 17 specialty lines in 14 production plants strategically located in Mexico. Employs approximately 30,000 workers. PiSA USA serves as the nearshore contract manufacturing arm, offering pharmaceutical and medical device CMO services. Company is a Socially Responsible Enterprise (ESR) for 15 consecutive years. Offers 'Maquila de Productos' (contract manufacturing) as a core service.

Lisapharma S.p.A. is an Italian pharmaceutical company specializing in the contract manufacturing of sterile injectable products, located in Erba (Como), Italy. The company provides sterile fill/finish services for vials, syringes, and cartridges, with capabilities in lyophilization. The website domain lisapharma.com is no longer active, but the company operates from lisapharma.it and is FDA-registered for manufacturing.

Lundbeck Pharmaceuticals Italy SpA

Italy

Lundbeck Pharmaceuticals Italy SpA is an Italian API manufacturer with 80 years of industry experience, producing Active Pharmaceutical Ingredients including Metoclopramide Hydrochloride. Part of the Lundbeck Group (Denmark), they operate multiple FDA-registered facilities with extensive inspection history. While primarily a proprietary pharma manufacturer (Lundbeck is known for CNS drugs), their Italian operation manufactures APIs and has FDA-approved products across injectable and oral dosage forms. They also have clinical trial activity in CNS/Neurology and Immunology.

Mabion S.A.

Poland

Mabion S.A. is a Polish end-to-end biologics CDMO offering Drug Substance manufacturing, fill/finish, process development, cell line development and banking, and analytical services. Headquartered in central Poland (1.5 hours from Warsaw airport), they position themselves as a European CDMO partner for pharma and biotech companies. Their capabilities span the full biologics lifecycle from gene to vial.

MabPlex International

China

MabPlex International is a China-headquartered CDMO providing comprehensive biomanufacturing services for the global biopharmaceutical and biotechnology industry. They offer innovative CRO and CMO services for biologics, with facilities in China and the USA (MabPlex USA). They are expanding CDMO services and manufacturing capacity to meet global biologics demand, with multiple manufacturing sites.

mAbxience

Spain

mAbxience, a Fresenius entity, is a global CDMO with 14+ years of experience in the development and manufacture of biopharmaceuticals, specializing in biosimilars and monoclonal antibodies. They are FDA-registered with two FEI numbers for analysis and API manufacture. They have partnered with HP to develop AI solutions for optimizing monoclonal antibody and biosimilar production. Their CDMO platform offers tailored solutions with quality, agility, and flexibility in manufacturing.

Macleods Pharmaceuticals Ltd

India

Macleods Pharmaceuticals Ltd is one of India's top 10 pharmaceutical companies, operating as a CDMO for developing, manufacturing, and globally distributing pharmaceutical products. They produce diverse dosage forms including solid orals, liquid orals, topical formulations, injectables, metered dose inhalers, and dry powder inhalers across therapeutic areas including anti-TB, antimalarials, antiretrovirals, antidiabetics, antihypertensives, and antiasthmatics. They have 152 FDA-approved products, WHO prequalified medicines, and manufacturing facilities compliant with UK MHRA, US FDA, TGA, and WHO guidelines. They operate in 100+ countries.

MassBiologics, a division of UMass Chan Medical School, is a US-based biologics CDMO with over 100 years of history driving discoveries to products. The organization develops novel biologics for diseases of public health importance and offers CMO services including bulk drug manufacture of monoclonal antibodies, vectored therapeutics (gene therapy), and aseptic fill finish. The facility includes approximately 25,000 sq ft of cGMP manufacturing space with dedicated aseptic fill finish and bulk drug substance areas. FDA-registered with 3 FEI numbers. Produces the FDA-licensed Td vaccine and has partnerships for gene therapy manufacturing (SparingVision, PTC Therapeutics).

Nectar Lifesciences Ltd.

India

Indian pharmaceutical company with vertically integrated API and formulation manufacturing. FDA registered with 2 FEI numbers (operations: ANALYSIS, API, FDF). Offers CDMO services alongside own branded products. Manufactures both APIs (including beta-lactam antibiotics) and finished dosage forms across oral solids, injectables, and lyophilized products.

NovaCina is a sterile injectable CDMO based in Perth, Western Australia, launched by Bridgewest Group. The company manufactures sterile injectable drug products for all phases from development through commercial production. NovaCina has expanded its facility with a high-tech SA25 GMP filling line for small-batch sizes and has since merged with BioCina to create an end-to-end CDMO offering integrated biopharmaceutical and small molecule contract manufacturing services.

OLIC (Thailand) Limited is one of the largest toll and contract manufacturers in Southeast Asia for branded pharmaceutical and healthcare products. The company is a subsidiary of Fuji Pharma and serves over 30 multinational companies including most Big Pharma organizations. OLIC's PIC/S-compliant manufacturing facility produces a wide range of dosage forms including sterile liquids, oral solids, semi-solids, and liquids, serving markets in Thailand, Southeast Asia, Japan, Australia, the US, and Europe.

Pharmaceutical Manufacturing Research Services (PMRS) is a U.S.-based cGMP contract manufacturer providing sterile CDMO manufacturing services. Located in Horsham, Pennsylvania, the company specializes in sterile injectable manufacturing and spray drying capabilities.

Pii (Pharmaceutics International, Inc.), acquired by Jabil in February 2025, is a US-based CDMO specializing in complex formulations. With over 30 years of experience and 300+ scientists and support staff, Pii handles potent compounds, complex formulations, aseptic injectables, complex oral dosage forms, and high-potency soft gels. Offers phase-appropriate support from early development through commercial manufacturing. Located in Hunt Valley, Maryland. 100% FDA licensed with 5 drug product approvals in 2023.

PSM GmbH is a German pharmaceutical CDMO specializing in aseptic fill and finish services for drugs, biologics, and biopharmaceutical products. The company offers end-to-end commercial fill and finish services with state-of-the-art flexfill filling-line technology and formulation development capabilities. Limited website data is available, but search results consistently identify PSM as a specialized aseptic fill/finish CDMO.

Rajasthan Antibiotics Ltd. (RAL) is an Indian integrated pharmaceutical company specializing in the manufacture of Active Pharmaceutical Ingredients (APIs), particularly sterile penicillins and injectable APIs. They supply APIs including tazobactam sodium sterile, ketoprofen for injection, and avibactam to global pharmaceutical companies.

Reig Jofre (Laboratorio Reig Jofre, S.A.) is a Spanish pharmaceutical company founded in 1929 that operates both as a pharmaceutical company with its own products and as a CDMO. They have four development and production centres in Europe (two in Toledo, one in Barcelona, one in Sweden) with over 1,100 employees. Their CDMO capabilities include sterile lyophilizates, sterile liquids, non-sterile liquids, and beta-lactam manufacturing. Known for excellence in freeze-drying technology and advanced sterile manufacturing. FDA-registered with manufacturing and analysis operations, though regulatory history shows 3 OAI inspections.

Shree Venkatesh International Limited (SVIL) is an Indian manufacturer and exporter of male and female human hormonal products, including both APIs and finished dosage forms. The company offers contract manufacturing services for pharmaceutical drug products and APIs, with a focus on hormonal therapies. SVIL markets its products internationally through branded and generic channels.

Stelis Biopharma is a leading, fully integrated biopharmaceutical CDMO based in India (Bangalore) with over 30 years of operational excellence. They brand themselves as 'OneSource' -- a multimodal specialty pharma CDMO with end-to-end capabilities across multiple tech platforms and therapeutic modalities. Their capabilities span biologics (microbial and mammalian cell culture, drug substance and drug product), complex sterile injectables (35 approved ANDAs and 19 commercialized drug products in the US), drug-device combinations (20+ automatic/semi-automatic assembly stations for prefilled syringes, pen injectors, autoinjectors), and soft gelatin capsules (2.4 billion per year capacity). They operate 5 state-of-the-art facilities approved by various regulatory bodies. Syngene acquired Stelis Biopharma's Unit 3 plant in Bangalore for biologics manufacturing.

Flagship Biotech International is an Indian pharmaceutical company headquartered in Mumbai with manufacturing facilities across India (Tarapur, Navsari, Naroda, Baddi). It manufactures a broad range of pharmaceutical dosage forms including tablets, capsules, injectables, LVP, SVP, inhalers, ointments, and suppositories for its own brands and contract manufacturing for organizations globally in 45+ countries.

LubecaFill

Germany

LubecaFill is a German contract filling company offering sterile filling services for liquid dosage forms using Ready-to-Fill (RTF) technology. They provide filling into pre-sterilized vials, syringes, and cartridges, as well as contract filling of ampoules, oral and topical liquid dosage forms, and diagnostics/laboratory consumables. GMP certification is in preparation.

Lyomark Pharma GmbH

Germany

Lyomark Pharma GmbH is a German CDMO specializing in sterile medicinal products. They organize contract manufacturing based on dossiers they compile and maintain, and offer regulatory services. Through their subsidiary Lyocontract, they operate a state-of-the-art pharmaceutical manufacturing site. They have 39 FDA-approved products across injectable, oral solid, and liquid dosage forms. The company focuses on niche indications for the hospital market with global distribution.

Mac-Chem Products (India) Pvt. Ltd.

India

Mac-Chem Products (India) Pvt. Ltd., part of the NMM Group (Naprod), is a pharmaceutical API manufacturer specializing in Oncology, General APIs, and Bulk Sterile products. They have manufacturing plants in four locations employing around 800 professionals. Naprod (parent) is a pioneer in lyophilization with an ultra-modern manufacturing facility. They hold multiple international regulatory approvals including USFDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, and WHO-GMP/ISO certifications.

Morgen Pharmaceutical Services (MPhS), operating as Stason Pharmaceuticals, is a US-based CDMO offering end-to-end drug development and manufacturing services. Located in Irvine, California, the facility can produce over 2 billion oral doses per year with batch sizes from 0.5 kg to 600 kg. The company offers API synthesis (through offshore affiliates), formulation development, pre-formulation studies, solid dosage manufacturing (tablets and capsules), high-containment operations for highly potent compounds (OEL < 1 µg/m³), and injectable/liquid manufacturing through a partner facility in Tainan, Taiwan. FDA-registered with 2 FEI numbers and 11 FDA inspections (8 NAI, 3 VAI).

Indian pharmaceutical CDMO specializing in pre-finished formulation intermediates (PFI) and finished dosage forms (FDF). Manufactures oral solids, oral liquids, injectables, ophthalmics, topicals, and inhalation products. Strong focus on pellet technology and nanotechnology-based drug delivery systems. CRAMS (Contract Research and Manufacturing Services) provider.

Nanjing Sino Pharmaceutical Ltd.

China

Chinese pharmaceutical company specializing in production, R&D, and export of generic medicines globally. Covers 1,000+ products across antibiotic, antimalarial, analgesic-antipyretic, cardiovascular, respiratory, antiviral/anti-cancer, hormone, and other therapeutic categories. 20+ years of international registration and export experience in dozens of countries. FDA registered with 3 FEI numbers.

NEON LABORATORIES LTD

India

Indian pharmaceutical company (established 1984) that emerged as a leader in anesthesia and critical care products. Manufactures 500+ products sold in 70+ markets. Multi-located manufacturing facilities including API and formulations. Started as contract manufacturer for anesthesia products (1992) and grew into branded generics. Major plant at Palghar with 460 million units capacity. Has dedicated manufacturing units for cephalosporins and oncology to avoid cross-contamination. 2000+ employees. FDA registered with 3 FEI numbers, 29 inspections (13 NAI, 15 VAI, 1 OAI). Began API production in 2008. Also has medical devices division (HOSPRO).

CD BioGlyco is a supplier dedicated to advancing glycobiology research through high-quality products and services. The company provides various carbohydrates, glycoconjugates, enzymes, and related products, as well as glycobiology-related research services. It is primarily a research reagent and specialty biochemical supplier, not a pharmaceutical contract manufacturer.

Lucent Biotech Limited

India

Lucent Biotech Limited is an Indian third-party pharmaceutical manufacturer founded in 2006 in Roorkee (Haridwar). They manufacture a wide spectrum of pharmaceutical formulations and serve as suppliers for multiple Indian and multinational pharmaceutical companies. They are a contract manufacturer (third-party manufacturer) of pharmaceutical finished dosage forms.

Lyophilization Technology, Inc. (LTI)

United States

Lyophilization Technology, Inc. (LTI) is a US-based CDMO focused on lyophilization (freeze-drying) development and sterile clinical supply manufacturing. They offer development sciences (formulation development, thermal analysis, cycle design, product characterization, pilot plant scale-up), clinical manufacturing (Phase I, II, and toxicology), and technical services. They have specialized capabilities in dual chamber cartridges and syringes, and isolation/containment for potent compounds.

Chinese pharmaceutical company (subsidiary of Nanjing Pharmaceutical Co., Ltd.) focused on R&D, manufacturing, and marketing of APIs and formulations primarily in nephrology. Key products include Iron Sucrose Injection, Compound alpha-Ketoacid Tablets, Sevelamer Carbonate Tablets, and Phloroglucinol Injection. Listed as a small molecule API CMO in industry directories. FDA registered with 2 FEI numbers. Not primarily a contract manufacturer -- manufactures and sells own branded products, but listed in CMO directories.