TGA-Approved CDMOs

Asymchem

China

Asymchem is a leading CDMO with 25+ years of experience, 9,700+ employees, and eight R&D and manufacturing sites. They specialize in complex chemistry for small molecule APIs, including peptide synthesis, and provide comprehensive CMC services from R&D through commercial production. They have 65+ successful regulatory inspections (FDA, NMPA, TGA, MFDS) and 1,100+ active clients with 600+ clinical and 40+ commercial projects.

Cadila Pharmaceuticals Ltd

India

Cadila Pharmaceuticals Ltd is one of India's largest privately-held pharmaceutical companies, operating as both a branded generics company and CDMO/CMO. The company covers the entire life science value chain including R&D, API manufacturing, formulations across 45 therapeutic segments, drug discovery, and contract manufacturing services including vaccines.

Chemwerth

China

ChemWerth is a US-headquartered, family-owned full-service generic API development and supply company established in 1982. The company provides end-to-end services including new product development, compliance auditing, regulatory filing (500+ DMFs filed globally), and CMO management across 30+ FDA-approved manufacturing facilities in the US, Europe, India, and China. ChemWerth offers the CATALYST program for comprehensive API development and manufacturing.

C.O.C. Farmaceutici Srl

Italy

C.O.C. Farmaceutici Srl (Content Group) is an Italian pharmaceutical CDMO specializing in contract development, manufacturing, and filling of liquid, gel, and lyophilized pharmaceuticals, medical devices, and cosmetics. The company operates three production plants in Italy (Sant'Agata Bolognese, Rovereto sul Secchia, and Pomezia) with 500+ employees, generating 108.3 million euros in turnover in 2025, with particular expertise in ophthalmic and respiratory products. The Pomezia facility (Tubilux Pharma) is FDA approved.

Cohance Lifesciences

India

Cohance Lifesciences is a global CDMO platform specializing in small molecule APIs, antibody-drug conjugates (ADCs), and nucleic acid chemistry, serving customers in nearly 60 countries with 80+ molecules in their portfolio. The company operates 20+ manufacturing and R&D facilities across India and the US, with multiple USFDA and EDQM-accredited sites, offering end-to-end solutions from drug discovery through commercialization including high-potent APIs (OEB 4 & 5), oligonucleotides, and finished dosage forms.

Hanmi Pharm. Co. Ltd

South Korea

Hanmi Pharmaceutical is a major South Korean pharmaceutical company providing comprehensive CDMO services across the entire pharmaceutical lifecycle. The company operates through Paltan Smart Plant (producing 6+ billion chemical drug tablets annually), Pyeongtaek Bioplant (FDA-approved biopharmaceutical manufacturing with 12,500L bioreactors), and Hanmi Fine Chemical (API and raw materials including mRNA cap analogs, NTP, and lipids). Hanmi has partnerships with global pharma companies including Lilly, Roche, and Sanofi.

Harman Finochem Ltd

India

Harman Finochem Ltd is an India-based CDMO/CMO specializing in the manufacture and export of Active Pharmaceutical Ingredients, with core competencies in Metformin HCl, Fenofibrate, Divalproex Sodium, and over 45 other APIs. The company also operates a finished dosage form facility with EU GMP approval, capable of producing 2 billion tablets per year.

Life Pharma FZE

United Arab Emirates

Life Pharma FZE (LIFEPharma) is a UAE-based pharmaceutical manufacturer and the only USFDA-approved pharmaceutical company in the United Arab Emirates. Part of VPS Healthcare, the company manufactures a wide range of generic finished dosage forms including tablets, capsules, and liquid oral preparations at its facility in Jebel Ali, Dubai. LIFEPharma is building a new oncology manufacturing facility in Abu Dhabi.

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.

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.

Swati Spentose Pvt Ltd

India

Swati Spentose Pvt Ltd is a global research-oriented Indian pharmaceutical company with over 50 years of history, specializing in API and intermediate manufacturing with a strong focus on neglected and rare diseases, particularly interstitial cystitis. The company operates multiple USFDA-inspected API and intermediate manufacturing facilities in Vapi, Gujarat, and holds global FDA accreditations from USFDA, EDQM, PMDA, COFEPRIS, MFDS, WHO-GMP, and others.

Sypharma Pty Ltd

Australia

Sypharma is an Australian specialty contract manufacturing group operating since 2005. They develop and manufacture therapeutic goods, veterinary products, and specialty consumer products. They specialize in contract manufacturing for early clinical through Phase III clinical trials and have multipurpose cleanrooms for oral, topical, and parenteral drug products. They manufacture both large and small volume parenterals and have a veterinary manufacturing suite. Licensed by FDA, TGA, and ISO 13485 certified. They partnered with Schott on sterile fill/finish capabilities.

XL LABORATORIES PVT LTD

India

XL Laboratories Pvt Ltd is an EU GMP, PIC/s, TGA, and WHO GMP approved pharmaceutical formulations and nutraceuticals research and manufacturing company established in 2001. It holds Star Export House status from the Indian Ministry of Commerce for outstanding international market performance, with presence in 40+ countries.

BioCina

Australia

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

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.

OneSource Specialty Pharma Limited

India

OneSource Specialty Pharma Limited (formerly Stelis Biopharma Limited) is India's first specialty pharma pure-play CDMO, offering multimodal end-to-end capabilities across drug-device combinations, complex sterile injectables, biologics, and soft gelatin capsules. The company operates five state-of-the-art facilities in Bengaluru with 35 approved ANDAs and 19 commercialized drug products in the US market.

Purisys

United States

Purisys is a US-based CDMO specializing in custom Active Pharmaceutical Ingredients (APIs) and chemical synthesis projects, with over 40 years of commercial pharmaceutical production experience. The company is a global leader in pharmaceutical-grade cannabinoids and psychedelic compounds, with DEA-secure manufacturing capabilities. Purisys also offers reference standard synthesis and qualification with over 300 commercial standards. The company was recently acquired by Siegfried alongside Noramco.

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.

Titan Laboratories Pvt Ltd

India

Titan Laboratories Pvt Ltd is an integrated Indian pharmaceutical company and the first Indian pellet company to receive EU-GMP Written Confirmation. Established in 2004, it manufactures and exports pharmaceuticals and APIs across 47 countries, with specialization in pellets, granules, tablets, capsules, and creams/ointments. The company holds EU-GMP, TGA, ANVISA, WHO-GMP, MFDS, and other international approvals.

Australian ALKALOIDS Trading PTY LTD

Australia

Australian Alkaloids Trading (AAT) is a 100% Australian-owned API manufacturer specializing in naturally extracted alkaloid APIs and semi-synthetic compounds derived from Duboisia plants. AAT is a joint venture of Phytex and Australian Alkaloids, with 60+ years of combined experience. The company controls its entire supply chain domestically in Australia, from Duboisia plantations through extraction, purification, and final API release. Products include scopolamine (hyoscine) derivatives, atropine derivatives, and methscopolamine bromide. AAT's facilities are cGMP licensed with the TGA, USFDA inspected, and supply USP and PMRJ reference standards. They have a history of zero product recalls.

Bushu Pharma is Japan's premier CDMO with over 25 years of experience, specializing in contract manufacturing of solid dosage formulations, sterile injectables, lyophilized products, and prefilled syringes for both clinical trial supplies and commercial products. The company operates five factories in Japan with GMP certifications from 56 countries including FDA, EMA, and PMDA, serving over 90 pharmaceutical companies globally with nearly 50% of sales from foreign-affiliated clients.

CTX Life Sciences Pvt. Ltd.

India

CTX Life Sciences Pvt. Ltd. is a vertically integrated API and intermediate manufacturer based near Surat, Gujarat, India. The company operates a world-class manufacturing facility with a total area of 147,227 sqm, capable of handling complex and hazardous reactions, with DSIR-approved R&D and a collective reactor capacity of around 900 KL. The facility has been inspected by US FDA (6 times), EDQM, BfArM (Germany), TGA (Australia), PMDA (Japan), Health Canada, ANVISA (Brazil), and COFEPRIS (Mexico).

Divis Laboratories Limited

India

Divis Laboratories is one of the world's top 3 API manufacturers and a trusted CDMO partner for over 25 years, serving 12 of the top 20 Big Pharma companies. Operating three world-class manufacturing facilities near Hyderabad, Visakhapatnam, and Kakinada in India with over 16,500 m3 combined reaction capacity, they manufacture generic APIs (30 commercial products), custom synthesis for Big Pharma (small molecules, high potent, peptides), and nutraceutical ingredients including carotenoids and vitamins.

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.

Novotech

Australia

Novotech is a global full-service clinical research organization (CRO) headquartered in Australia, specializing as a biotech partner across all clinical trial phases. The company operates extensively in Asia-Pacific and globally, providing clinical trial management, regulatory advisory, and scientific consulting services for biotech and small to mid-sized pharma companies.

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.

CMAX Clinical Research

Australia

CMAX Clinical Research is one of Australia's largest and most experienced clinical trial centres, established in 1993 in Adelaide. The company conducts Phase I-III clinical trials with up to 78 inpatient beds, specializing in supporting national and international pharmaceutical sponsors with clinical research services in its Bio-Med City precinct location adjacent to The Royal Adelaide Hospital.

Olive HealthCare is a fully-integrated Indian pharmaceutical company specializing in the development, manufacturing, and marketing of soft gelatin capsule formulations for pharmaceutical, OTC, and dietary supplement products. Operating three state-of-the-art manufacturing units in India, the company provides CDMO services including toll manufacturing and full development for global partners.

Scientia Clinical Research

Australia

Scientia Clinical Research is an Australian contract research organization providing clinical trial services. The company operates a clinical research facility at the University of New South Wales (UNSW) Randwick Hospitals Campus and provides clinical development and business development services for pharmaceutical and biotech companies.

Clinigen

United Kingdom

Clinigen is a global specialist pharmaceutical services company focused on accelerating access to medicines. The company provides clinical trial supplies management, pre-approval and managed access programs, licensed and unlicensed pharmaceutical distribution, regulatory affairs services, and marketing authorisation holding, operating in 130+ countries. Clinigen divested its manufacturing arm (Lamda Laboratories) to Adragos Pharma.