USFDA’s final product approvals see a dip for Indian players

Indian pharmaceutical firms are witnessing a dip in the rate of final product approvals from the US drug regulator in the H1CY2018. From 126 last year, final approvals received till date this year are around 101.

Why is this important

  • Indian pharma companies received final approvals for 304 abbreviated new drug applications (ANDAs) out of the total 846 given globally. This accounted for ~36% of the overall approvals.
  • Though the Indian count has slipped, the overall USFDA approvals have increased globally during the first half of 2018.

usfda approvals

  • Cadila Healthcare has received 8 final approvals in July alone. Cadila Healthcare’s US subsidiary, too, received final approvals for over 16 products during H1FY2018
  • Sun Pharmaceuticals received its first product approval after 5 years for the Halol site in July.
  • Aurobindo Pharma received around 22 approvals between January and June 2018.
  • Lupin got 8 final approvals between January and June 2018.
  • Dr. Reddy’s Laboratories got 7 final approvals between January and June 2018.


The rate of product approvals from the USFDA has improved in the past few years and it approved 46 novel medicines in 2017 which was a 21-year high. However, the Indian pharmaceutical companies file for generic medicines that have expired patent. While there is pricing pressure in the generic drug markets, higher drug approvals for Indian players can help them mitigate it and see higher turnover.

Cadila Healthcare Ltd. (CMP: Rs.363, Mkt Cap: Rs. 37,315 crores, FY2020 P/E:16.7)

Sun Pharmaceuticals Ltd. (CMP: Rs.567, Mkt Cap: Rs. 1,36,050 crores, FY2020 P/E: 23.8)

Aurobindo Pharma Ltd. (CMP: Rs.594 , Mkt Cap: Rs. 34,835 crores, FY2020 P/E: 11.7)

Lupin Ltd. (CMP: Rs. 815, Mkt Cap: Rs. 36,868 crores, FY2020 P/E:18.4)

Dr. Reddy Laboratories Ltd. (CMP: Rs. 2070, Mkt Cap: Rs. 34,332 crores, FY2020 P/E:16.2)

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