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Leading CDMO Companies in Australia

Your Trusted Australian Partners for Contract Manufacturing and Development

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FDF / DRUG PRODUCTS manufacturing site

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Boronia, VIC, Australia

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SENN India | Non-GMP Plant | Hyderabad, India
India

SENN India | Non-GMP Plant | Hyderabad, India

Senn Chemicals

Large scale non GMP manufacturing site for peptide intermediates, organic synthesis, LPPS operations and scale up production.

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: APAC

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING

SENN India | R&D Lab | Hyderabad, India
India

SENN India | R&D Lab | Hyderabad, India

Senn Chemicals

R&D centre for peptide and organic chemistry with SPPS, purification, lyophilisation, analytics and particle engineering support.

SERVICES: Logistics, Development services, Analytical / QC services, Quality Assurance services, Packaging

REGION: APAC

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING

BATCH SIZE: Small

Viswa Laboratories Pvt Ltd
India

Viswa Laboratories Pvt Ltd

Viswa Laboratories Private Limited

CRAMS/CDMO, APIs, Intermediates and specialty chemicals.

MARKETS: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)

REGION: APAC

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC

SERVICES: Development services, Manufacturing services

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (R) Respiratory system

CONTROLLED SUBSTANCES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

COMPLIANCE: World Health Organization (GMP / HACCP)

Pharmaron API Commercial Synthesis Shaoxing (China)
China

Pharmaron API Commercial Synthesis Shaoxing (China)

Pharmaron

Commercial API Small Molecules /Peptides Synthesis.

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

MARKETS: NMPA (China), FDA (USA)

REGION: APAC

COMPLIANCE: FDA (cGMP), ISO, NMPA (China GMP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

ProBio CDMO | Biologics Platform
China

ProBio CDMO | Biologics Platform

Probio

Global GCT and biologics CDMO, accelerating your pipeline from gene to commercial market.

REGION: APAC

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), EMA (EU GMP)

BATCH SIZE: Large, Small, Medium

USE: Human

CATEGORY / PRODUCT: BIOLOGICS

Hikal Ltd | Bangalore, India
India

Hikal Ltd | Bangalore, India

Hikal Ltd.

cGMP Process Development, Scale-up and Manufacturing of Small Molecule APIs, NMEs and Intermediates from grams to tones.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

REGION: APAC

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), COFEPRIS, Halal Research Council, ECOVADIS, TGA (Australia GMP), EMA (EU GMP)

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: COSMETICS, NUTRACEUTICALS, CHEMICAL-SYNTHETIC, SERVICES

USE: Human, Veterinary

SERVICES: Development services, Manufacturing services

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V06) Nutrients

CARBOGEN AMCIS | Shanghai, China
China

CARBOGEN AMCIS | Shanghai, China

CARBOGEN AMCIS

Large scale manufacturing.

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: APAC

BATCH SIZE: Large, Small, Medium

USE: Human

CATEGORY / PRODUCT: OLIGONUCLEOTIDES, CHEMICAL-SYNTHETIC, SERVICES

COMPLIANCE: ANVISA (Brazil B-GMP), NMPA (China GMP)

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

Apeloa Pharmaceutical Co., Ltd.
China

Apeloa Pharmaceutical Co., Ltd.

Apeloa Pharmaceutical Co., Ltd

Apeloa CDMO provides world-class discovery, development, and manufacturing services for APIs, Intermediates, and RSMs.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)

REGION: APAC

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ECOVADIS, NMPA (China GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC

SERVICES: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging

Adragos Pharma | Kawagoe
Japan

Adragos Pharma | Kawagoe

Adragos Pharma

Our facility provides best-in-class manufacturing of tablets and ampoules.

CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)

SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: APAC

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), EMA (EU GMP)

BATCH SIZE: Large

USE: Human

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CATEGORY / PRODUCT: SERVICES, FDF / DRUG PRODUCTS

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site

Seacross Pharmaceutical Co Ltd

As one of three core sites, alongside the R&D center and formulation plant, our API manufacturing facility plays a vital role in the integrated supply chain.

CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: APAC

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF

BATCH SIZE: Large, Small, Medium

USE: Human

BSL (Biological Safety Level): 1, 2, 3, 4

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones, (V04) Diagnostic agents

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day)

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

The R&D Center plays a fundamental role in supporting the development of both APIs and finished dosage forms.

COMPLIANCE: MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF, DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

BSL (Biological Safety Level): 3, 4, 1, 2

CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: APAC

BATCH SIZE: Large, Small, Medium

USE: Human

Australia boasts a rapidly expanding ecosystem of CDMO companies delivering high-quality pharmaceutical development and manufacturing services. Known for their strong regulatory compliance, innovative technologies, and robust scientific capabilities, Australian CDMOs play a growing strategic role in supplying global markets with advanced drug products. Whether you require early-stage development or large-scale commercial manufacturing, Australia’s CDMO landscape provides reliable, world-class solutions tailored to your project needs.

Why Choose Australian CDMOs?

Featuring Cutting-Edge Facilities and Technology: Australian CDMOs invest heavily in modern infrastructure, automation, and GMP-certified facilities. Their focus on precision, data integrity, and advanced technologies makes them trusted partners for complex pharmaceutical products.

Ensuring Regulatory Excellence: Australia’s regulatory framework, governed by the TGA and aligned with global standards such as EMA and FDA, ensures that CDMOs in Australia deliver products meeting strict safety, efficacy, and quality requirements.

Acting as a Strategic Asia-Pacific Gateway: Positioned as a bridge between Western and Asian markets, Australia offers exceptional logistical advantages. Australian CDMOs can efficiently supply pharmaceutical products to high-growth APAC regions while maintaining Western-quality compliance.

Key Services Offered by Australian Contract Manufacturers

Providing High-Quality Analytical and QC Services: Australian contract manufacturers maintain rigorous quality control systems across every step of development and production, ensuring consistency, compliance, and mitigation of manufacturing risks.

Fostering Innovation and Advanced Development: Australian CDMOs are internationally recognized for their strong focus on research, advanced formulation technologies, bioprocessing, and emerging modalities such as RNA platforms and cell therapies.

Delivering Flexible and Scalable Production: Contract manufacturers in Australia offer adaptable production options—from pilot-scale batches to full commercial capacity—supporting biotech startups as well as global pharmaceutical companies.

Advantages of Partnering with CDMOs in Australia

Maintaining Global-Quality Standards: Australian CDMOs are widely respected for their strict adherence to GMP standards, robust documentation practices, and reliable delivery performance.

Leveraging Innovation Hubs Across Australia:

  • New South Wales: Home to advanced biologics, RNA manufacturing, and biotechnology clusters.
  • Victoria: Strong in small molecules, sterile manufacturing, and pharmaceutical R&D.
  • Queensland and Western Australia: Growing ecosystems for clinical trial supply, bioprocessing, and specialty manufacturing.

CDMO companies in Australia

Some of the top CDMO companies in Australia:

  • IDT Australia: GMP-certified CDMO offering active pharmaceutical ingredient (API) manufacturing, oral solid dose development, clinical trial supply, and analytical services. [See CDMO profile]

Related Information

Leading CDMO Companies in APAC

Leading CDMO Companies in China

Leading CDMO Companies in India

Let MAI CDMO Network Help You Find the Right Australian CDMO Partner

Choosing the right CDMO is essential to the success of your pharmaceutical project. With their strong scientific base, globally aligned regulatory standards, and robust manufacturing capabilities, Australian CDMOs provide reliable and compliant solutions for any development stage. Whether you are a biotech innovator or an established pharmaceutical company, Australia offers a world-class environment for outsourcing.

Let us help you identify the ideal CDMO partner in Australia. Contact us today to discover tailored solutions for your project.