Our Services

Vitex is a global leader in the contract manufacturing of complementary medicine. In working with us, you’ll have access to extensive commercial capabilities, scale and capacity; a fully integrated best-in-class facility based in Sydney, Australia; a wide spectrum of dosage forms manufactured on the latest state-of-art equipment available in the market today; and a partner with a vision predicated on quality, innovation and integrity.


Our Product Development program draws upon Vitex’s extensive expertise in manufacturing and pharmacological knowledge. Dedicated to innovation, our technical experts are rigorous in identifying and sourcing the latest research in pharmaceutics to apply in the manufacture of therapeutic goods.

Our Solutions

In working in close collaboration with our manufacturing teams, production design is embodied directly into the R&D process to ensure successful commercial-scale production. The result is an innovative, effective and attractive finished product ready for market shelves.

A dedicated Research & Development (R&D) Laboratory, offers industry stakeholders – brands, universities and research institutes alike – access to the latest technology available in complementary medicine manufacturing. As a hub for innovation, the R&D Laboratory offers stakeholders access to pilot scale manufacturing and testing equipment to facilitate galenical trials, new product development and research studies.

Our product development services include

Accelerated stability testing
Chemical and microbiological evaluation
Delivery system selection
Formulation development
Manufacture of galenical trials
New Product Concepts
Product presentation
Raw material selection
Screening and optimisation
Trial sample provisions


The Therapeutic Goods Act 1989 (The Act) applies to both the supply of therapeutic goods in Australia and the export of therapeutic goods from Australia. A key requirement of the legislation is that all complementary medicines, such as herbal, vitamin, mineral and nutritional supplements must be included in the Australian Register of Therapeutic Goods (ARTG), including those that are exported.

Our Solutions

Our Regulatory Department, comprised of highly skilled and experienced professionals, offers clients ongoing counsel on regulatory planning to attain permits required in Australia and markets around the world. Our reputation and relationships allow us to provide strategic regulatory advice throughout the stages of your product’s lifecycle.

We have a proven track-record of listed and approved products registered with various health authorities around the world. With this breadth of experience and scientific knowledge, Vitex can facilitate all aspects of this process by providing the following specialist services to assist you in covering the criteria for regulatory compliance.

Our regulatory services include

  • Advising eligibility of products and classification
  • Regulatory compliance for Listed Medicine
  • Preparation and submission of listing applications to the Therapeutic Goods Administration (TGA)
  • Evidence packages and therapeutic indications
  • Label compliance
  • Preparation of product Registration Dossier packages
  • Preparation of product Registration Dossier packages for international markets
  • Export certification
  • Halal Certification

Analytical Services

Vitex Analytical Services (VAS) boasts a brand new, state-of-the-art chemical and microbiological laboratory. The high-quality laboratory division, driven by an exceptional team of scientists offers a broad range of knowledge and expertise for your regulatory submissions and quality compliance.

With our extensive experience of manufacturing thousands of products, you’ll feel assured of the quality and integrity of your product and the scientific data of which it is founded.

We work at every stage of the product lifecycle allowing speed and efficiency of being in-house.

The fully equipped GMP laboratories provide comprehensive analysis of:

Method development

We cover a diverse range of international compendial and standard methods for chemical analysis, including the British, European, Japanese and United States Pharmacopeia; International Conference on Harmonisation (ICH); International Organization for Standardization (ISO); and Food Chemicals Codex (FCC).

We can also accommodate customer supplied methods. Our strong method development capabilities have yielded the successful development and validation of many new methods across various analytical techniques. Specialising in method development for UPLC, HPLC, GC and ICP analysis. We can support the entire process from protocol preparation, analytical testing to the final report.

Laboratory testing

Quality and integrity of data is paramount at Vitex and is governed by our Quality Assurance procedures. Protocols are strictly adhered to and established investigation procedures require the evaluation of results using sound scientific reasoning including but not limited to the following areas:

Physical Testing
  • Hardness
  • Disintegration
  • Dimensions
  • Friability
  • Uniformity of Weight
  • Specific Gravity
  • Loss on drying
  • Loss on Ignition
Chemical techniques and equipment
  • High/Ultra Performance Liquid Chromatography (HPLC/UPLC)
  • Gas Chromatography (GC)
  • High Performance Thin Layer Chromatography (HPTLC)
  • Inductively Coupled Plasma (ICP)
  • Dissolution Testing
  • Karl Fischer Titrator
  • Auto-titrator
  • Total Organic Carbon Analyser
  • Ultraviolet- Visible (UV/VIS) spectrophotometer
  • Refractive Index
Microbiological quality testing
  • Microbial Limit Testing
  • Total Viable Count (TVC)
  • Total Yeast, Mould & Fungi Count
  • Microbial Identification
  • Staphylococcus aureus
  • Pseudomonas
  • Escherichia coli and Coliforms
  • Salmonella
  • Candida albicans
  • Bile Tolerant Gram Negative Bacteria
  • Clostridia


The general principles around stability testing is to provide evidence on how the quality of a material or product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light. It also provides supportive data to establish the shelf life and recommended storage conditions for the product or retest period for a material. Stability information is vital for initial product registration and/or Product Quality Review (PQR).

Protocol development

The study approach varies depending on the product and at Vitex we offer a comprehensive stability trial design providing scope and rationale while taking into consideration the composition of a product (for example, the closure system, the technical difficulties that may be associated with stability testing of a complex multi-ingredient complementary medicine), as well as selecting the appropriate climatic zones for the end market:

  • Zone I: Temperate climate
  • Zone II: Subtropical and Mediterranean climate
  • Zone III: Hot and dry climate
  • Zone IVa: Hot and humid climate
  • Zone IVb: Hot and very humid climate
Stability storage conditions available

Our facilities operate in strict compliance to the Australian Standards of Pharmaceutical Good Manufacturing Practices and are stringently regulated by the Australian Therapeutic Goods Administration. All facilities are further audited by our Internal Quality Assurance Department to ensure complete compliance with the Australian code of therapeutic manufacturing.

  • 25ºC/60%RH:
    Long term conditions for cold stored products or retained/control samples
  • 30ºC/65%RH:
    Long term conditions for climatic zones I and II
  • 30ºC/75%RH:
    Intermediate and long term conditions for climatic zones I, II,III and IVa
  • 40ºC/75%RH:
    Accelerated conditions for climatic zones I, II, III and IV

Vitex Analytical Services provide a full suite of analytical tests to generate data which allows a definitive conclusion regarding the stability of a product. The strong method development capabilities have yielded the development and validation of successful stability indicating methods across various analytical techniques.

Reporting and trend analysis

Reporting of stability data is performed in a timely manner and any out of specification results are acted on immediately. Reports are issued providing a summary of the study detailing any trends along with recommendations for product reformulation.


Vitex is a global leader in the contract manufacturing of complementary medicine. In working with us, you’ll have access to extensive commercial capabilities, scale and capacity; a fully integrated best-in-class facility based in Sydney, Australia; a wide spectrum of dosage forms manufactured on the latest state-of-art equipment available in the market today; and a partner with a vision predicated on quality, innovation and integrity.

Our Solutions

As part of our innovation strategy, the acquisition of custom-designed technologically advanced equipment in 2017 has been a core advantage for the company. Through this investment in new more efficient state-of-the-art equipment, Vitex now has a greater manufacturing output leading to a quicker turnaround and speed to market than the competition.

Additional processes available:

  • Blending
  • Dry Granulation/Roller Compaction
  • Fluid Bed Dying
  • Milling
  • Compressing
  • Film Coating
  • High Shear Granulation

Private Label

Your products. Your logo. Your brand.

As a contract manufacturer for leading brands and private labels, we understand that every business has its own individuality. We specialise in delivering solutions from concept to shelf to help companies of all sizes meet their development and manufacturing needs at any stage or scale. We provide a combination of unparalleled best-in-class quality, reliability and compliance – underscored by a long-standing reputation for scientific and technical excellence by regulatory authorities around the world.
From choosing the right formulations and packaging to suit your needs, we offer personalised service and assistance in building your range. Our Innovation team will work with you to formulate products to suit and extend your product range with the versatility of multiple delivery formats. Our Regulatory Department will ensure compliance in the distribution country of your choice while our Manufacturing, Analytical and Packaging Divisions will ensure your product is made fast and ready to market.


We offer a broad packaging portfolio and have the expertise in supporting you with design, labelling and packaging solution services to enhance product compliance and consumer attractiveness.
With high-capacity primary and secondary packaging solutions for solid and semi-solid dosage forms, we’re well positioned to streamline your supply chain and deliver a finished product from concept to shelf. With support from our Regulatory, Analytical and Quality Assurance divisions, you’ll have access to the most up-to-date counsel on stability, quality assurance and safety.

By choosing Vitex as a packaging partner, we can get your products
to market faster for commercial success.

Global supply chain management

Our best practice procedures facilitate the reliable and efficient turnaround of products to meet your delivery needs.

We have developed an integrated manufacturing and packaging logistics system to allow for more efficient timelines to ensure the prompt delivery of quality products anywhere in the world.
A proven track record in delivering goods on time ensures our brand is synonymous with reliability. Our customised inventory management processes allow tracking systems to facilitate seamless supply chain management.

Simplify your supply chain with Vitex as your strategic partner.

How can we help?

We offer solutions across your product formulation development, analytical services and supply globally.