Shilpa Medicare's Unit III, Advanced Analytical Characterization Laboratory clears US FDA remote record review
Drug Approval

Shilpa Medicare's Unit III, Advanced Analytical Characterization Laboratory clears US FDA remote record review

The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing

  • By IPP Bureau | July 31, 2022

The US FDA has concluded Remote Record Review of Shilpa Medicare Limited ('SML' or 'the Company'), Unit III, Advanced Analytical Characterization Laboratory situated at Dabaspet, Bengaluru, Karnataka without any objectionable conditions or observations. The review was conducted during 15th to 18th Nov 2021.

The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing, Nitrosamine testing, Elemental Impurity testing, Extractable & Leachable testing, Glass Delamination testing etc.

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