Wanbury has secured the Good Manufacturing Practice (GMP) Compliance Certificate for its Tanuku Plant from Australia's Therapeutic Goods Administration (TGA), the regulatory authority responsible for therapeutic goods in Australia. The certificate covers the manufacturing of the six Active Pharmaceutical Ingredients (APIs) -- Metformin Hydrochloride, Tramadol Hydrochloride, Sertraline Hydrochloride, Diphenhydramine Hydrochloride, Mefenamic Acid and Paroxetine Hydrochloride Hemihydrate.
The certificate was issued on October 28, 2026 and is valid until December 9, 2028, subject to the TGA's applicable re-inspection requirements. With this approval, the TGA will proceed with issuing GMP clearances to Australian sponsors associated with the manufacturing facility, enabling the necessary regulatory clearances for the supply of the approved APIs to the Australian market.
Wanbury, one of India’s fastest growing pharmaceutical companies amongst the ‘Top 50 Companies’ in India (as per ORG-IMS), has a strong presence in API global market and domestic branded Formulation.
