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“This is to inform you that one of the Company’s API Manufacturing site situated at Block No. 588, Savli-Karachiya Road, At & Post: Gothada, Tal. Savli, Dist: Vadodara, Gujarat has received approval from Therapeutic Goods Administration (TGA), Australia,” Bajaj Healthcare said in a regulatory filing.
This site, already approved by the USFDA and EU, is now eligible to supply APIs directly to Australia and New Zealand, as well as to global drug product manufacturers targeting these markets. This approval, valid for 24 months, boosts the company’s standing as a global supplier of APIs.
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“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,” Bajaj Healthcare said.
Bajaj Healthcare hopes this development will open the doors to more contract manufacturing opportunities, bolstering its position in the international market. Shares of Bajaj Healthcare Ltd ended at ₹432.05, up by ₹51.00, or 13.38% on the BSE.
Also Read: Bajaj Healthcare signs development and supply agreement for an API with a European entity
