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Title : REGULATORY REQUIREMENTS FOR PARENTERAL PRODUCT IN US, AUSTRALIA AND MALAYSIA WITH SPECIAL EMPHASIS ON STABILITY AND LABELLING REQUIREMENTS
Authors : Bhargava Nupur, Shah Darshil, Maheshwari Dilip
Abstract : The drug Regulatory Requirement in US, Australia, and Malaysia countries is on the way of continuous improvement. Regulatory Requirement includes Regulatory framework, Administrative Requirements, Stability Requirements, Process Validation Requirements and Labelling Requirements. Regulation of Parenteral drug is becoming stricter day by day as its demand is increasing day by day. This article describes a comparative evaluation on Regulation of Parenteral product and it also provides brief overview of ICH CTD And ASEAN CTD. This article will be helpful to the industry to plan a better strategy for Parenteral drug Registration within short time.

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