New botanical extract: Aussie regulator TGA will be asked to approve branded Pelargonium sidoides ingredient

26-Oct-2021 - Last updated on 26-Oct-2021 at 01:24 GMT

PELAFORCE™ has proven clinical activity as an antiviral, antibacterial, expectorant, and immune modulator.

South African firm Afraceuticals and its exclusive Australian distributor Pathway International are applying for a branded Pelargonium sidoides extract to receive regulatory approval in the country.

The partnership will see their branded Pelargonium sidoides extract, PELAFORCE™, become available to brands and formulators in Australia and New Zealand for the first time.

The firms are applying for regulatory approval with the Therapeutic Goods Association (TGA), a legislative requirement for new ingredients used in complementary medicines in Australia.

Once approved, the ingredient will be available to brands and formulators for use in supplements, functional foods, and liquids. For now, it can also be directly formulated into Export Only finished products.

PELAFORCE™ will be made available to the New Zealand market for immediate use in dietary supplements and has proven clinical activity as an antiviral, antibacterial, expectorant, and immune modulator.

Rooted in sustainable African ethnopharmacology, Afraceuticals says it is committed to combining twenty-first century science and innovation with ancient African indigenous knowledge. Through close relationships with rural communities, the team engages on a personal level with the keepers of this knowledge. Afraceuticals is also a leader in sustainable harvesting and is involved in various high impact conservation projects.

True African botanical

Ryan Hooker, Commercial Director at Afraceuticals, said: “We’re delighted to announce our new distribution partnership with Pathway International. With their illustrious industry track record and their professional approach, combined with their reach into Australia and New Zealand, we have the utmost confidence that the peoples of this region will soon be able to enjoy the benefits of a true African botanical.

“Based in the highlands of South Africa - close to the source of the root - we ethically and sustainably source, dry and process our product, extracting the highly sought after medicinal botanical powder. PELAFORCE™ EMA1170™, our Pelargonium sidoides water soluble powder extract, is accompanied by a DMF (Active Substance Master File - 3.2S) and is manufactured in a GMP Facility according to the European monograph (EMA Monograph).”

Pathway International is a distributor of speciality healthcare ingredients across Australia and New Zealand, supplying businesses in the complementary medicine; food and beverage; pharmaceutical; cosmetics; and veterinary sectors.

Wayne Coote, Managing Director at Pathway, added: “We are really excited about the opportunity that we have with the PELAFORCE™ brand of Pelargonium sidoides extract from Afraceuticals in the ANZ markets. We have a long history of bringing new ingredients to the Australian market and have a proven track record of gaining TGA approvals for many of them.

“This fits perfectly within our portfolio of best-in-class ingredients and makes a very natural and strong addition to our science-backed portfolio, which is designed to meet the growing consumer demand for natural health solutions. We are truly excited to be Afraceuticals’ distribution partner in ANZ and look forward to establishing a new market for their PELAFORCE™ raw material in various formats.”