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Manufacturing Standards

Sypharma has many years’ experience in developing, manufacturing and marketing of therapeutic goods, hospital products, consumer products & veterinary products. We contract-manufacture products for a range of companies and for both the local and international markets.

Sypharma is a Good Manufacturing Practice (GMP) compliant manufacturer and performs under the requirements of ISO13485.

A comprehensive Qualification and Validation Program is adhered to in order to prove control of the critical aspects of the production operations and the team continually work to improve systems, responding to ever-changing regulatory and customer requirements.

Sypharma holds a Therapeutic Goods Administration (TGA), USFDA, APVMA and ISO 13485  licence to manufacture, package and store non-sterile & terminally sterilised medicinal products for human use, Category 2 & 4 veterinary products, and Medical Device Manufacture licence.

All therapeutic goods manufactured and marketed by Sypharma comply with the Therapeutic Goods Administration (TGA) and the State Department of Health. Products are either registered or listed on the Australian Register of Therapeutic Goods (A.R.T.G.) administered by the TGA and comply with all labelling requirements.