TGA Australia concludes GMP inspection at Shilpa Medicare’s Telangana facility

17 Oct 2023 Evaluate

The Therapeutic Goods Administration (TGA), Australia has successfully closed-out a GMP inspection at Shilpa Medicare’s finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana. The facility is involved in manufacturing, packaging, labelling, testing and release of finished dosage forms (sterile injections and non-sterile oral solids) for the treatment of various forms of cancer and adjuvant therapy.

This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years. The successful closure of this inspection will allow the company to register and market its products in Australia and other rest of world markets which recognize Australian GMP. The company remains committed to maintain the GMP status and quality standards as per the expectations and standards of Global Regulatory Authorities.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.

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