CDER Center for Clinical Trial Innovation (C3TI)

CGMP/Finished Pharmaceuticals/Adulterated

Record Date: 9/19/2025
Entity Name: Sun Pharmaceuticals Medicare Ltd.
FEI Number: 3002957541
Record Type: 483
Country: India
Establishment Type: Sterile Drug Manufacturer

FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner.

This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.

This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:

CGMP/Finished Pharmaceuticals/Adulterated