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Glenmark Pharma's Baddi unit gets 7 observations from US FDA

Our Bureau, Mumbai
Tuesday, November 28, 2017, 16:30 Hrs  [IST]

Glenmark Pharmaceutical, a Rs.8,950 crore plus pharma major from Mumbai, has received another blow from US FDA. Glenmark's Baddi unit, which contribute around 10 per cent of its sales for US sales, underwent an US FDA audit from November 6, 2017 to November 11, 2017 and US FDA issued seven observations through the form 483.

Due to this development, Glenmark scrip declined by Rs.19.40 today and closed at Rs.571.80 on BSE. The scrip recently touched to its yearly lowest level at 565 on November 16 2017. The scrip touched to its yearly highest level at Rs.973 on February 7, 2017.

As at the end of first half, the company was marketing 126 generic products in US market. It has 61 applications pending in various stages of the approval process with the US FDA, of which 28 are Paragraph IV applications. During the second quarter, it received eight final approvals taking the tally to 13 final approvals for the first half of this financial year. It filed three ANDA applications with US FDA and plans to file an additional seven applications in the forthcoming quarter. It also filed 2 US DMFs and 1 EU CEP and completed several other regulatory filings in other key markets including Brazil and South Korea.

 

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