Sirio secures TGA GMP Certification to support strategic growth in Australia

September 10, 2025 | Australia

The Ma’anshan site approval covers pastilles, oral liquids, and powders SIRIO Pharma (SIRIO) – the global nutraceutical contract development and manufacturing organisation (CDMO) – announces that its Ma’anshan facility in China…

The Ma’anshan site approval covers pastilles, oral liquids, and powders

SIRIO Pharma (SIRIO) – the global nutraceutical contract development and manufacturing organisation (CDMO) – announces that its Ma’anshan facility in China has been granted a Certificate of GMP Compliance by the Therapeutic Goods Administration (TGA) of Australia. The approval will support SIRIO’s expansion into the rapidly growing Australian market, providing both local and international brands with greater product development and manufacturing options.

Sirio is a global nutraceutical CDMO with extensive R&D capabilities at its sites in China, the USA, and Europe. With this new TGA compliance, Australian brands can partner with SIRIO to accelerate new product development, gaining access to the CDMO’s unrivalled research capabilities and expertise.

The certificate of compliance (Certificate Number: MI-2023-CE-13177-1) confirms that the Ma’anshan site meets TGA’s rigorous Good Manufacturing Practice (GMP) requirements for the manufacture of non-sterile listed therapeutic goods, including pastilles, oral liquids, and powders. The certification covers end-to-end finished product manufacturing, ensuring that products exceed TGA standards for safety, consistency, and quality.

“Achieving TGA GMP certification at our Ma’anshan facility is a key step in SIRIO’s strategic expansion into the Australian market,” commented Ryan Li, Head of Quality at SIRIO. “It reflects our commitment to help brands develop new formulations tailored to the needs of Australian consumers, while meeting both international and national regulatory standards.”

The Ma’anshan site is SIRIO’s largest and most advanced facility, with an annual production capacity of up to 2.4 billion gummies, 80 million functional drink bags, and 34 million bottles of nutritional powders. The site supports both large-scale commercial manufacturing and flexible customised production, combining sustainable and intelligent manufacturing with world-class quality. It has been recognised as a ‘Smart Factory’ and ‘Green Factory’ by Anhui Province in 2023, aligning with SIRIO’s ambition of delivering innovative and fully compliant solutions to the Australian market.

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