A Regulatory Strategy by Keeping the Same Batch Size for Commercial That of Exhibit Batches May Have Untold Advantages Over Traditional Approach When Filing an ANDA for an Immediate Release Tablet Dosage Form

Author(s): Harinath Reddy Gangasani * and Nataraj. K. S.

Abstract: Generic Drug Manufacturer (Applicant) submit Abbreviated New Drug Application (ANDA) to USFDA based upon an innovator Drug or an RLD (Reference Listed Drug) [1]. One of the critical documents to be included in the original ANDA is the master production batch record(s) for the largest intended production runs (i.e., commercial batch records) that is/are no more than 10 times the exhibit batch(es). Proposing any increased batch size than the exhibit batch scale in the Original ANDA may lead to unwarranted additional post approval commitments from the applicant. In this article, Author elaborates the advantages when the applicant proposes same batch sizes for exhibit and commercial scale i,e “No Scale Up” in the original ANDA submission.

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