FDA’s clearance to Sun Pharma’s Gujrat plant,India.

FDA’s clearance to Sun Pharma’s Gujrat plant,India.

Overview

  • Post By : Khushboo Sharma
  • Source: Microbioz India
  • Date: 13 June, 2018

Sun Pharma’s Halol plant in Gujarat, India has finally got some relief from the US FDA after receiving satisfactory report from the Food and drug administration. Since 2014 the plant faces many issues with the manufacturing standards and the pressure was piled up after receiving a warning letter for this plant I Gujarat in 2015.

Not, it is becoming possible for the India’s largest drug manufacturer to relaunch their products in the US market from the Halol plant and regain their financial growth once again.

The inspection of the facility was done between February 2-23 in which the inspection team gave a remark of “VAI- Voluntary action indicated” to the Sun pharma’s Halol plant in Gujarat, which affected the financial growth of the Sun pharma organization as its very crucial for its future export plans to the US..

The inspection of the facility was done between February 2-23 in which the inspection team gave a remark of “VAI- Voluntary action indicated” to the Sun pharma’s Halol plant in Gujarat, which affected the financial growth of the Sun pharma organization as its very crucial for its future export plans to the US. As the plant use to contribute around 15 percent of the overall revenues of the Sun pharma and over 20 percent of its US earnings. There was a re-inspection held in 2016 but that was not so satisfactory for the FDA to give a clearance to the plant.

Whereas sun pharma’s other unit Karkhadi was also smacked with a warning letter issued by the FDA in year 2014.

All this have created a great financial trouble to sun’s as last month the sun pharma reported in their fourth-quarter and full-year 2018 report that in full year 2019 the revenue won’t meet analysts’ expectations die to the poor sales of generic and the rising competition in the U.S. market, which accounts to be around 35 percent of its total profits.

About Author

Khushboo Sharma

Khushboo Sharma

Actively working as an Editorial member of Microbioz India