Sirio secures TGA GMP certification to support strategic growth in Australia

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

AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease

The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations

Lupin achieves GMP certification from TGA Australia for Dabhasa API facility

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

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

Lupin receives approval from TGA Australia for Tiotropium Dry Powder

Tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsule

Lincoln Pharma gets Australian TGA approval

The company plans to expand its portfolio in regulated markets aggressively

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

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms