Sirio secures TGA GMP certification to support strategic growth in Australia

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

ZIM Laboratories granted marketing authorization for Tamsulosin + Dutasteride capsules in Australia

Tamsulosin, an alpha-1 adrenergic receptor blocker, combined with Dutasteride, a dual 5- alpha-reductase inhibitor, is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in adult men

Lupin achieves GMP certification from TGA Australia for Dabhasa API facility

iNGENu CRO, Quantum BioPharma to launch Australian trial for chronic nociplastic pain in MCAS patients

The trial targets MCAS/MCAD, an under-recognized, debilitating condition with an unknown cause and no cure

Marksans Pharma’s manufacturing facility at Verna, Goa approved by Australian TG

The products will be manufactured in Goa India and marketed & distributed in Australian markets

Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ

The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market

Sun Pharmaceuticals receives approval for Winlevi in Australia

Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older

Biocon Biologics partners with Sandoz Australia for Biosimilars Trastuzumab and Bevacizumab

The agreement is effective from January 1, 2024 and commercialisation commenced on February 1, 2024

Shilpa Medicare Unit IV, Jadcherla has cleared TGA, Australia GMP inspection

This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years

Gufic Biosciences receives TGA Australia and ANVISA Brazil approval for Parecoxib 40mg injection

Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management