Credibility
Manufacturing certifications reveal the quality of our operations. This includes the quality of our facility, organization of our operations, our adherence to important procedural steps, and our control over quality and safety and how they are implemented and recorded. Each country has its own standards of excellence and subsequent certification. The mark of a truly globalized facility lies in the certifications they acquire from regions that most strictly enforce quality and safety standards. Listed below are some of our global certifications that foster pride in our practices.
United States –
SUN TEN Laboratories
In 2010, SUN TEN Laboratories received certification through the National Products Association (NPA) as a GMP compliant dietary supplement manufacturing facility. In 2015, SUN TEN Laboratories received the Public Health and Safety Organization’s NSF International Certification.
Australia
In 1992, SUN TEN became the first Chinese herbal extraction manufacturer from Taiwan to obtain GMP certification from the Australia Therapeutic Goods Administration (TGA). SUN TEN is the only Chinese herbal extract manufacturer from Taiwan to receive PIC/S GMP certification from Australia’s TGA, in 2004, 2006 and 2009.
Japan
In 1975, SUN TEN began exporting to Japan. SUN TEN is the first TCM manufacturer from Taiwan to qualify for reimbursable prescription by the Japanese Health Insurance Plan. SUN TEN is also the first Chinese herbal extraction manufacturer from Taiwan to be an Accredited Foreign Manufacturer in Japan.
Malaysia
In 1996, SUN TEN products were approved for an Import Drug License by the Drug Control Administration (DCA) in Malaysia.
Taiwan
SUN TEN was among the first Chinese herbal extraction manufacturers in Taiwan to receive Taiwan’s GMP certification in 1988.
What is GMP?
Good Manufacturing Processes (GMP) are guidelines that outline the aspects of production and testing that create a quality product. GMP encompass the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods and dietary supplements, pharmaceutical products, and medical devices. Many countries have legislated GMP procedures and regulations that pharmaceutical and medical device companies must follow.
What is TGA?
The Therapeutic Goods Administration (TGA) carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.
In Australia, medicinal products containing herbs, vitamins, minerals, and nutritional supplements, homoeopathic medicines and certain aromatherapy products are referred to as “complementary medicines”. These are regulated as medicines under the Therapeutic Goods Act of 1989. Complementary medicines are comprised of traditional medicines, including traditional Chinese medicines, Ayurvedic medicines and indigenous Australian medicines. All TCM products exported to Australia require TGA listing for which the TGA GMP Certificate is a prerequisite.
What is PIC/S?
PIC/S refers to joint international pharmaceutical inspection authorities: Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme which together provide co-operation in the field of GMP. PIC/S’ mission is “to lead the international development, implementation and maintenance of harmonized Good Manufacturing Practice standards and quality systems of inspectorates in the field of medicinal products.”
PIC/S establishes cohesive GMP standards, guidance documents, training, and inspection. Cohesive international collaboration of PIC/S facilities promotes GMP standards that are internationally verified by strict approval yet are harmonious in global commerce. Australia’s TGA is a participating authority in PIC/S, therefore, TGA GMP inspection is based on PIC/S GMP guidance.
Affiliated Accomplishments
In 2001, SUN TEN co-developed a cancer adjuvant with PhytoCeutica Inc. for cancer therapy and filed a botanical drug IND (Investigational New Drug) with the US FDA.
SUN TEN has also manufactured an herbal formula for Phytopharm PLC (UK) to be used in clinical trials in Europe. The formula is currently marketed as an herbal supplement to treat skin disorders in dogs.
