Shilpa Medicare Jadcherla facility clears TGA, Australia GMP inspection
Karnataka: Shilpa Medicare has recently informed through a BSE filing that the Company’s finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana state has successfully closed-out a GMP Inspection from TGA, Australia, as per communication received on 17 th October 2023.
The facility is involved in the 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 said.
Read also: Shilpa Medicare gets Health Canada GMP approval for Jadcherla facility
Shilpa Medicare Limited started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of API and Formulation globally in different regulated markets.
Read also: Shilpa Pharma Lifesciences Unit II Raichur facility clears PMDA Japan GMP inspection
