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Launched in 2005, Australia’s speciality contract manufacturing group Sypharma specialises in manufacturing products for Phase 1, 2, and 3 clinical trials and have a variety of multipurpose rooms for the production of topical or oral drugs and devices. The Company holds several years of experience in developing, producing and marketing ofconsumer products, hospital products, therapeutic goods and veterinary products.
Sypharma operates in compliance with the Good Manufacturing Practice (GMP) and manufactures products under license of the Therapeutic Goods Administration (TGA), Australian Pesticides and Veterinary Medicines Authority, FDA and ISO13485.
Sypharma’s Quality Assurance laboratory is armed with accurate analytical equipment like HPLC (High-performance liquid chromatography), NIR (Near Infra Red) and other equipment for the testing of finished products and raw materials.
A Quick Glance at Sypharma’s Products
Sypharma produces, package sand stores terminally sterilised and non-sterile medicinal goods for human use and Category II and IV veterinary products. All of the Company’s therapeutic goods are produced and marketed in compliance with the State Department of Health and the TGA.
Its products are either registered or listed on the TGA-administered Australian Register of Therapeutic Goods and conform with all labelling requirements.
The Company’s Hartmann’s IV solution, also termed as Ringers Lactate Solution, has been approved by the FDA for distribution. The Company is also distributing its fluids under Sykes IV Lyte Injection (Electrolytes).
Sykes is a leading Australian brand, which develops and produces animal pharmaceutical products, with its parent company Sypharma, beginning with R&D down to commercial volumes. Sykes’ animal product range, distributed under five different brands, combines to deliver a suite of metabolic injections, ointments and sterile range of IV fluids recognised and admired by animal handlers, veterinary surgeons and trainers.
Offers Top-Notch Contract Manufacturing Services
Notably, Sypharma provides contract manufacturing services for firms operating in veterinary, pharmaceutical and consumer goods industries that need to outsource their manufacturing, with a unique program for drug development and clinical trial material.
The Company’s services establish the confidence of product sponsors that their goods will be produced, packaged and released for supply to the market, in compliance with regulatory requirements and in minimal time, all from one facility.
In addition to offering a cost-effective option, the Company’s services enable contract manufacturing partners to harness the benefits of their products’ faster supply to the market. Moreover, the Company’s commitment to quality, manufacturing flexibility and production capability ensure its partners that their product abides with existing licensing standards.
The Company is licensed to aseptically Fill and Finish for Stage 1 and 3 Clinical Trials and focuses on small run manufacturing. The Company’s contract manufacturing services comprise:
- Material sourcing and product registration
- Formulation and process development
- Terminal sterilization and scale-up manufacturing
- Analytical method development
- Regulatory and documentation support
- Analytical and microbiological testing
- Aseptic filling
- Stability studies and validation support
- Labelling andpackaging
- Primary distribution
Besides dealing with contract manufacturing development, Sypharma works with its partners to innovate and create new technologies. The Company has anestablished track record of effective drug development, both in the national and international arena.
The Company possesses the expertise and technology to become a single point of contact for firms seeking to develop novel medical devices or pharmaceuticals. The Company undertakes drug development process within top-notch Australian facilities from pre-clinical to stage 3 and beyond.
In a nutshell, Sypharmaseems to be ideally positioned to become Australia’s leading provider of life enhancement pharmaceutical products, backed by its extensive industry experience and specialised manufacturing equipment services.
