The approval is valid for a period of 24 months.
The said site has already received approval from United States Food and Drug Administration (USFDA) and European Union.
The pharmaco stated that this recognition by TGA of site’s manufacturing and compliance capabilities would pave the path for direct supplies of API to this stringent regulated territory as well as supplies to drug product manufacturers across the globe, who are supplying their finished product in the territory of Australia and New Zealand.
Post this recognition, the company expects to attract more CDMO contracts from existing and new clients.
Bajaj Healthcare a leading manufacturer of APIs, intermediates and formulations. It has a strong presence globally in countries like Europe, USA, Australia, Africa, Middle East and South America.
The company reported standalone net profit of Rs 94.64 crore in Q2 FY25 as compared with net loss of Rs 34.60 crore in Q2 FY24. Revenue from operations jumped 31.5% YoY to Rs 133.08 crore in Q2 FY25.
The counter hit a 52-week high of Rs 452.05 in today’s intraday session.