Respiratory CDMOs

The Ritedose Corporation

United States

The largest US CDMO specializing in sterile Blow-Fill-Seal (BFS) technology for aseptic manufacturing of unit-dose medications. Based in Columbia, South Carolina with a 500,000+ sq ft facility and production capacity of over 2.6 billion units annually. Delivered more than 12 billion doses since 2012 with no patient interruptions. Provides both CDMO services and has a generics division. Offers the largest nebulized drug portfolio in the US. Key products include ophthalmic, respiratory, and inhalation medications. Has co-developed 80%+ of new BFS products over the past decade. 100% customer retention for 25 years. Recent investments include $17M cGMP lab expansion and seventh Syntegon packaging line. 16 FDA-approved products.

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).

Tiofarma

Netherlands

Tiofarma is a Dutch CDMO specializing in complex semi-solid formulations (creams and ointments) and emergency nasal sprays, offering services from pre-formulation through commercial supply. The company operates an EU-GMP and FDA-licensed manufacturing facility in Oud-Beijerland, Netherlands, with in-house R&D and analytical laboratories.

Ultratech India Limited

India

Ultratech India Limited is an integrated Indian pharmaceutical company established in 1992, manufacturing pharmaceutical finished dosage forms, Active Pharmaceutical Ingredients, and drug intermediates. They specialize in pulmonary drug delivery systems (DPI and pMDI inhalation products) and offer Custom Research and Manufacturing Services (CRAMS) including custom synthesis, process development, private labeling, and contract manufacturing. Extensive API portfolio covers cardiovascular, antifungal, antihistamine, anti-asthmatics, antiviral, erectile dysfunction, and other therapeutic segments. WHO GMP, ISO 9001, ISO 14001 certified.

UNI-PHARMA S.A.

Greece

UNI-PHARMA S.A. is a major Greek pharmaceutical company (part of the Tsetis Group) with over 60 years of operations. It researches, develops, produces, and distributes pharmaceutical products, food supplements, and medical devices. It holds the first place in sales (units) among purely Greek companies in the Greek pharmaceutical market. The company offers contract manufacturing services (listed as CMO/CDMO on PharmaSource) while also marketing its own extensive portfolio of generic medicines across multiple therapeutic categories. Their product range includes a very wide array of small-molecule generics.

Unolab Manufacturing

Spain

Unolab Manufacturing is a Spanish CDMO founded in 2008, specialized in development and manufacturing of sterile unit-dose liquid formulations using Blow-Fill-Seal (BFS Bottelpack) technology. Focused primarily on ophthalmic and respiratory products including saline solutions, hyaluronic acid formulations, and inhalation products. Operates an 18,000 m2 facility in Getafe, Spain with capacity exceeding 600 million doses per year. Products exported to 25+ countries. Also offers tech transfer, out-licensing, and product development services across the full product lifecycle.

Upperton Pharma Solutions

United Kingdom

Upperton Pharma Solutions is a UK-based CDMO with an award-winning 60,000 sq ft development and manufacturing facility (Trent Gateway) in Nottingham. They provide integrated services from pre-clinical through late-phase manufacture for oral solids, nasal, pulmonary, and parenteral dosage forms. They recently built a new 7 million GBP sterile fill/finish manufacturing facility with MHRA submission. Services include formulation development, clinical supply manufacturing (Phase I-III), process scale-up and optimization, quality control, and analytical development and validation.

URSATEC GmbH

Germany

URSATEC GmbH is a German company founded in 1993 specializing in preservative-free spray dosing systems and contract manufacturing. They are the inventor and market leader in dosing systems for preservative-free sprays using their patented 3K and COMFORT packaging technologies. They offer a 'ONE Source' concept covering product development, raw materials sourcing, dosage systems, sterilization, sterile filling, lab services, and regulatory affairs for pharmaceuticals, medical devices, food supplements, and cosmetics. They operate from Tholey, Germany with ISO 13485, ISO 9001, and ISO 15378 certifications. While they do offer contract filling services for sterile products through qualified partner companies, their primary identity is as a dosing system inventor and preservative-free product specialist.

Volcke Aerosol Italy S.r.l.

Italy

Volcke Aerosol is a family-owned contract manufacturer with 55 years of experience specializing in the development and filling of aerosols and sprays. The company operates three production sites in Europe (Belgium, Italy, UK) and provides full-service solutions from formulation development through filling, labeling, and packaging.

Woodstock Sterile Solutions

United States

Woodstock Sterile Solutions is a leading CDMO specializing in aseptic pharmaceutical manufacturing of sterile liquid formulations using advanced blow-fill-seal (BFS) technology. Based in Woodstock, Illinois, the company has a decades-long track record in clinical development through full-scale commercial production, with particular expertise in ophthalmic and respiratory products as well as complex solutions, suspensions, and emulsions.

Ami Lifesciences Pvt Ltd

India

Ami Lifesciences Pvt. Ltd. is one of India's fastest-growing API manufacturing companies, established in 2006 in Vadodara, Gujarat. The company manufactures 88+ APIs across multiple therapeutic areas with 69 DMFs filed globally, operating three manufacturing plants with 1,500 metric tons of production capacity and offering CDMO/custom synthesis services.

Avanti Polar Lipids (Croda Pharma)

United States

Avanti Polar Lipids, now a Croda Pharma brand (Avanti Research), is a US-based manufacturer and CDMO specializing in high-purity lipids for pharmaceutical and diagnostic applications. Through Croda Alabaster, their FDA-inspected cGMP manufacturing division, they provide contract manufacturing of lipid APIs, excipients, and adjuvants for vaccines and immunotherapies. Services span from custom lipid synthesis at 25mg scale through clinical trial materials to commercial-scale bulk production (1L to 55L batches), including liposome and nanoparticle formulation in cGMP manufacturing suites. They offer lipid-based drug delivery system development, method development and validation, ICH-compliant stability testing, and full regulatory support for IND/NDA submissions.

Cipla

China

Cipla is a major Indian multinational pharmaceutical company that manufactures and markets its own branded generic medicines globally. While Cipla has formed joint ventures with CDMOs like Kemwell Biopharma for biosimilar development, the company itself is a pharmaceutical manufacturer selling its own products, not a contract manufacturer for others.

Glenmark (incl. API arm Glenmark Life Sciences)

Argentina

Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company focused on branded and generic formulations, with an API manufacturing arm called Glenmark Life Sciences. The company manufactures APIs and finished dosage forms primarily for its own portfolio, spanning dermatology, respiratory, oncology, and cardiovascular therapeutic areas. Glenmark Life Sciences produces over 120 APIs across multiple manufacturing sites in India.

Krewel Meuselbach GmbH

Germany

Krewel Meuselbach GmbH is a German owner-operated, medium-sized pharmaceutical company headquartered in Eitorf (NRW) with a production facility in Gehren, Thuringia. They are primarily a manufacturer of herbal (pflanzliche) medicines and also offer contract manufacturing (Lohnherstellung) services for third parties. Their contract services include manufacturing of liquids and tablets, packaging with serialization and aggregation capabilities, warehouse/logistics, and sales support. They produce exclusively in Germany.

Maharshi Pharma Chem Pvt Ltd

India

Maharshi Pharma Chem Pvt Ltd is an Indian API manufacturer specializing in corticosteroid APIs since 2014. The company manufactures APIs to cGMP standards with expertise in developing corticosteroids for pharmaceutical companies producing topical, inhaled, and injectable formulations. Products include Betamethasone, Dutasteride, and other corticosteroid intermediates. The company operates from Ahmedabad, India.

Malladi Drugs & Pharmaceuticals Ltd

India

Malladi Drugs & Pharmaceuticals Ltd is a leading Indian API manufacturer founded in 1980, specializing in Ephedrine and Pseudoephedrine salts. The company exports APIs to over 60 countries and operates three FDA-registered facilities (3 FEI numbers). FDA inspection history shows 11 inspections (2 NAI, 8 VAI, 1 OAI) with latest in 2025. The company manufactures controlled substance APIs under strict regulatory oversight.

Medicair

Greece

Medicair is a privately-owned Greek pharmaceutical company founded in 1998, operating with vertical integration from development and manufacturing to commercialization. The company offers contract manufacturing services for solid, semi-solid, and liquid dosage forms including OTCs and food supplements. Their manufacturing specialization is in pMDI inhalers, external use sprays, foam sprays, unit dose ampoules, semi-solids, and capsules, with a production capacity of 8 million canisters. They invest over 10% of turnover in R&D and have 80+ INNs and 150+ branded generic products. Medicair also offers product development, licensing, and distribution partnerships globally.

Meenaxy Pharma Pvt Ltd.

India

Meenaxy Pharma Pvt Ltd is an Indian pharmaceutical company with over 20 years of experience specializing in the manufacture of pharmaceutical pellets and capsules. WHO GMP and ISO 9001:2015 certified, the company is a pioneer in novel drug delivery systems, producing neutral pellets (non-pareil seeds, sugar spheres USP, tartaric acid pellets, di-calcium phosphate pellets, MCC pellets), active drug coated pellets (doxycycline, omeprazole, curcumin, orlistat, indomethacin ER, itraconazole, dexlansoprazole, ketoprofen ER, mebeverine HCl SR), enteric coated pellets, and blended pellets (iron folic, mineral & vitamin). They serve clients including GSK, Aurobindo, and Dr. Reddy's, and export to 20+ countries. The company operates two manufacturing facilities with capsule filling capabilities and contract manufacturing services.

Melody Healthcare

India

Melody Healthcare Pvt Ltd is an Indian pharmaceutical company and part of The Singhania Group, specializing in the manufacturing of active pharmaceutical ingredients (APIs). The company focuses on niche, complex chemistry-driven APIs with expertise in respiratory and antibiotic therapeutic areas. Melody Healthcare has DMFs designed for global registrations and supplies APIs to over 105 countries. Key differentiators include micronization capability (particle size engineering from early-stage through commercial scale), backward integration from basic building blocks, and quality-by-design approach adhering to ICH guidelines. The company holds certifications from US-FDA, EDQM (ANSM France), TGA Australia, MFDS Korea, WHO-GMP, CDSCO, and ISO 9001/14001.

Micro-Sphere SA

Switzerland

Micro-Sphere SA is a Swiss pharmaceutical CDMO based in Ticino, Switzerland, specializing in spray drying, capsule filling, and a wide range of R&D services. The company has a 100% regulatory track record, has served over 200 clients from all continents, and worked with over 500 drug substances and drug products. Micro-Sphere operates ISO 8 clean rooms and is FDA-registered for manufacturing. The company has a partnership with Sferalp and provides spray drying of both aqueous and organic solutions.

Morepen Laboratories Limited

India

Morepen Laboratories Limited is an Indian pharmaceutical company with 40+ years of expertise in API and formulation manufacturing. The company has recently secured an INR 825 crore (approx. USD 100M) multi-year global CDMO mandate, marking a significant expansion into contract manufacturing. Morepen operates a scientifically integrated complex in Baddi with 10 dedicated manufacturing plants. The company exports to 80+ countries and holds FDA, WHO GMP, and EU GMP certifications. Known for the consumer brand Dr. Morepen (home health devices).

Raritan Pharmaceuticals, Inc.

United States

Raritan Pharmaceuticals is a US-based contract manufacturer specializing in OTC pharmaceuticals, consumer products, and high-end cosmetics. They develop, manufacture, and market generic OTC medicines and niche OTC brands. Their expertise includes chewable tablets, fast-dissolving tablets, powders, capsules, specialty liquids, gels, ointments, creams, and film-delivery systems. They operate from East Brunswick, NJ with FDA-registered manufacturing facilities. Notable regulatory history includes multiple recalls (15 Class II) and OAI inspection.

Recipharm AB

Sweden

Rechon Life Science AB is a subsidiary/entity within the Recipharm group, the global CDMO headquartered in Stockholm, Sweden. This entry represents the same Recipharm organization (same website: recipharm.com) with its extensive global manufacturing footprint of 15+ FDA-registered FEI numbers and 52 FDA inspections. The Perplexity research confirms Recipharm's specialization in oral solid dose, inhalation, sterile manufacturing, and HPAPI capabilities. Rechon may represent a specific Recipharm site or legacy entity. Duplicate of Recipharm AB entry -- capabilities are identical.

Sandoz

Austria

Sandoz is a global leader in generic and biosimilar medicines, spun off from Novartis in 2023 as a standalone company. It manufactures and markets generic pharmaceuticals and biosimilars but operates as a branded pharmaceutical company, not a contract manufacturer for third parties.

Scinai Immunotherapeutics

Israel

Scinai Immunotherapeutics is a NASDAQ-listed biopharmaceutical company that provides boutique biologics CDMO services through its Scinai Bioservices business unit, alongside its own I&I therapeutics pipeline. The CDMO offers end-to-end drug development and manufacturing from molecule selection through Phase 3 manufacturing, with over 20 years of experience in recombinant protein development. Scinai acquired a manufacturing site in Yavne, Israel from Recipharm and established a US subsidiary (Scinai Bioservices Inc.).

Supriya Lifescience Ltd.

India

Supriya Lifescience Ltd. is a publicly listed Indian generic pharmaceutical company established in 1987, primarily focused on API manufacturing and supply. The company has a leadership position in therapeutic segments including antihistamines, anti-asthma, and analgesic APIs, serving 1,500+ customers in 86+ countries. While the company mentions CDMO services, its core business is manufacturing and selling its own API portfolio.

Symbiotica Speciality Ingredients Sdn Bhd

Malaysia

Symbiotica Speciality Ingredients is a Malaysian-based manufacturer of steroidal, hormonal, and niche non-steroidal Active Pharmaceutical Ingredients. With over 20 years of experience, the company serves 250+ customers across 80+ countries with 78+ API products. The company holds PIC/s cGMP certification and products comply with US FDA, CEP, PMDA, and other global standards. Symbiotica also offers custom API manufacturing solutions from development to commercial production.

Vamsi Labs Ltd

India

Vamsi Labs Ltd. is a major Indian manufacturer of Active Pharmaceutical Ingredients (APIs) based in Solapur, Maharashtra. Founded over 28 years ago, the company operates a USFDA-approved, ISO 9001:2015/ISO 14001:2015/ISO 45001:2018 certified facility. Specializes in anti-asthmatic (respiratory), anti-migraine, and anti-psychotic APIs, with 60% of sales from antiasthma products. Products are manufactured in 3 blocks with 8 dedicated product lines containing 70 reactors (10L to 10,000L). Also offers CRAMS (Custom Research and Manufacturing Services) with capability for reactions from -60C to 280C. Has micronization capability for inhaled products using Malvern Mastersizer 2000. Holds US FDA EIR, CEP certifications for multiple APIs (Formoterol Fumarate, Salmeterol Xinafoate, Tiotropium Bromide, Fluticasone Propionate, etc.), WHO-GMP, and EcoVadis sustainability scorecard.

ABC Farmaceutici, an ICE Pharma company, is an Italian CDMO established in 1925 specializing in oral solid and liquid formulation manufacturing. Their 76,000 sqm facility in Ivrea (near Turin) is fully GMP certified and regularly inspected by AIFA and FDA. As part of ICE Pharma, they manage the entire drug supply chain from API through finished dosage form manufacturing.

Celerion

Austria

Celerion is a clinical research organization (CRO) specializing in early-phase (Phase I) clinical trials and translational medicine. The company provides clinical research solutions, innovative technologies, and therapeutic and specialty expertise to help get drugs to market faster. Celerion offers specialized procedures including echocardiograms, CSF collection, cognitive testing, imaging, and molecular/cellular capabilities including flow cytometry and ELISpot testing.

Fermion, a wholly owned subsidiary of Orion Corporation (Finland), is a CDMO specializing in developing, manufacturing, and marketing small molecule Active Pharmaceutical Ingredients (APIs), including HPAPIs, cytotoxics, steroids, generics, and controlled substances. Together with its parent Orion, it offers integrated contract development and manufacturing services for both drug substances and drug products, covering the full lifecycle from preclinical to commercial scale. FDA-approved since 1979 and EMA-approved since 1971.

JEWIM Pharmaceutical (Shandong) Co., Ltd. is a Chinese pharmaceutical company in transformation, focusing on innovative drugs and complex drug delivery systems including inhalation products, nasal sprays, and long-acting injectable microspheres. The company is an established CDMO/CMO partner for multinational pharma companies including Johnson & Johnson (Xian Janssen), Kenvue, and Bayer, with quality systems certified by US FDA and Australian TGA. Products are exported to over 80 countries.

Lupin Limited (Lupin Manufacturing Solutions)

Brazil

Lupin Manufacturing Solutions (LMS) is the CDMO arm of Lupin Limited, one of India's largest pharmaceutical companies. LMS offers integrated CDMO services spanning API manufacturing, formulation development, and finished dosage form production. They operate 16 FDA-registered facilities with 512 FDA-approved products. They have recently expanded into oncology with a dedicated block at Vizag, India, and formed a strategic alliance with PolyPeptide for peptide supply chain scaling. Their extensive regulatory track record includes FDA, WHO, and multiple international approvals.

Murli Krishna Pharma Pvt Ltd

India

Duplicate entry for Murli Krishna Pharma Private Ltd. (mkppl.com) - same company, same website domain. Indian pharmaceutical CDMO specializing in PFI and FDF products with CRAMS services.

Olpha (formerly Olainfarm JSC) is the leading pharmaceutical manufacturer in Latvia with over 50 years of experience and approximately 850 employees. The company produces finished dosage forms, active pharmaceutical ingredients, and intermediates across 10 therapeutic groups with a portfolio of more than 60 drug forms and 25 APIs. Olpha offers contract manufacturing and pharmaceutical co-development services, and exports to more than 60 markets. The company recently rebranded and aims to become a European top 10 pharmaceutical company.

Parexel International (MA) Corporation

Argentina

Parexel is a global contract research organization (CRO) providing clinical trial management, regulatory consulting, and biopharmaceutical development services. With over 24,000 professionals and 50+ clinical sites across five continents, the company offers Phase I-IV clinical trial services, CMC regulatory strategy, and real-world evidence generation. Parexel is primarily a CRO, not a drug manufacturer.

SEDICO Pharmaceutical Company is an Egypt-based pharmaceutical manufacturer and API producer, providing contract manufacturing (CMO/CDMO) services. The company manufactures a broad range of pharmaceutical products including oral solids, injectables, and various dosage forms. SEDICO has recently entered oncology drug production through a partnership with Sandoz Global to localize oncology pharmaceutical products in Egypt.

Stason Pharmaceuticals, Inc. is a US-based pharmaceutical company headquartered in Irvine, California, with CDMO services provided through its affiliate Western PharmSci. The company operates in both branded/generic pharmaceuticals and contract services. Their CDMO capabilities include turn-key drug development and manufacturing for oral solid dosage forms with particular expertise in high containment products (OEL down to 0.1 ug/m3) for oncology, CNS, and other potent compounds. Services span from pre-formulation characterization and API synthesis through commercial production (up to 600 kg), including analytical method development/validation, formulation development, clinical trial materials, and serialization. They hold 30+ ANDAs and have operations in 13 locations across 9 countries. Note: FDA issued a warning letter on July 8, 2020, citing significant CGMP violations for finished pharmaceuticals.

Sterling Italy (Sterling S.p.A.) is a long-established Italian manufacturer specializing in the development, optimization, and manufacturing of steroidal APIs including corticosteroids, hormones, anabolics, estrogens, and progestinics. The company operates GMP production plants in Perugia, Italy and exports APIs to over five continents.

Symbiotec Pharmalab is a leading Indian manufacturer of corticosteroid and steroidal-hormone APIs with a global leadership position. With over 30 years of experience, the company has evolved from lab-scale manufacturing to industrial-scale production, operating two FDA-approved facilities (Rau and Pithampur, Indore). The company offers integrated CDMO solutions across organic chemistry, biotechnology/fermentation, and complex injectable platforms. It holds a 50%+ global market share in key steroid API molecules and serves 200+ customers in 40+ countries.

Taiwanese CDMO specializing in transdermal drug delivery systems (TDDS), topical patches, and oral films. Over 30 years of experience in hydrogel patch, NSAID patch, and cosmetic patch development and manufacturing. Covers over 70% of OTC patches on the Taiwan market and exports to Asia, Europe, and North America. Also offers CMO and CRO services for transdermal patch development.

US-based topical and transdermal pharmaceutical CDMO, now merged with MedPharm (Durham, NC). Provides end-to-end services from formulation development through commercial manufacturing for topical, transmucosal, and transdermal drug products. Specializes in semi-solids, aerosols, liquids, injections, and transdermal patches. Offers in-vitro permeation testing (IVPT), in-vitro release testing (IVRT), disease activity models, tissue protein binding, and continuous flow technologies. GMP-certified manufacturing for generics, OTC, and prescription products.

Unither Pharmaceuticals is a global CDMO specializing in sterile and non-sterile liquid pharmaceutical forms, and the world leader in Blow-Fill-Seal (BFS) technology with annual production capacity exceeding 5 billion doses. Founded in 1993 in France, they operate 9 production sites across Europe, North America, South America, and China with 2,500+ employees. They offer contract manufacturing (clinical and commercial), formulation/analytical development, out-licensing of turnkey products, co-development partnerships, and regulatory support including CTD/eCTD submissions. Products include BFS single-doses, multi-doses, vials, sprays, stick packs, and ophthalmic solutions.

Zambon is an Italian multinational healthcare group founded in 1906 with EUR 899 million in revenues and 2,768 employees. The group operates as both a pharmaceutical company (Zambon Pharma) and a CDMO, offering contract development and manufacturing services ranging from development through commercial production. Manufacturing plants in Vicenza (Italy), Cadempino (Switzerland), Haikou (China), and Barueri (Brazil) supply 87 countries. Also includes Zach System (API custom synthesis) as its chemical division.

Acebright Group (Shanghai Acebright Pharmaceuticals) is a Chinese pharmaceutical company providing CDMO services through NMPA, FDA, EMA, and WHO-approved sites. They specialize in API manufacturing with over 20 years of technology development, and have a joint venture with Cipla for respiratory products in China.

Chongqing Huapont Shengchem Pharmaceutical Co., Ltd., founded in 1994, is a subsidiary of listed company Huapont Life Sciences. The company provides integrated R&D, production, and CDMO services for APIs and intermediates with 30+ years of experience, 700m3 reaction volume, 100+ R&D products, and registrations across US, EU, Japan, Korea, and China.

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.