Lupin Ltd has secured Good Manufacturing Practice (GMP) certification from Australia’s Therapeutic Goods Administration (TGA) for its Dabhasa facility in Gujarat, marking a significant milestone in its global regulatory footprint.
Key Highlights:
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The certification follows a successful onsite inspection by TGA, validating compliance with international manufacturing standards.
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The Dabhasa site specializes in Active Pharmaceutical Ingredients (APIs) and contract development, and is part of Lupin Manufacturing Solutions.
Strategic Significance:
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The GMP approval enhances Lupin’s ability to supply therapeutic goods to Australia and other regulated markets.
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It complements recent regulatory wins, including a clean inspection from the US FDA and an Establishment Inspection Report (EIR) with No Action Indicated status.
Operational Impact:
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The certification is expected to accelerate Lupin’s export pipeline and reinforce its reputation for quality and reliability.
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It also supports the company’s broader strategy to expand its presence in AsiaPacific and Europe.
Sources: Lupin.com, Indian Pharma Post, TGA Australia, Business Standard.