1. Addressing points raised by USFDA: Vista Pharma

Addressing points raised by USFDA: Vista Pharma

Vista Pharmaceuticals today said it is addressing all the issues raised by the US health regulator in a warning letter to the company for its Nalgonda facility in Telangana.

By: | New Delhi | Updated: July 13, 2017 7:05 PM
Vista Pharmaceuticals, Telangana, United States Food and Drug Administration, Nalgonda USFDA has issued a warning letter in response to the company’s detailed reply submitted on October 2016, Vista Pharmaceuticals said in a filing to BSE. (Reuters)

Vista Pharmaceuticals today said it is addressing all the issues raised by the US health regulator in a warning letter to the company for its Nalgonda facility in Telangana. The Hyderabad-based company has been issued a warning
letter by the United States Food and Drug Administration (USFDA) over significant violations of good manufacturing norms at its Nalgonda plant.

USFDA has issued a warning letter in response to the company’s detailed reply submitted on October 2016, Vista
Pharmaceuticals said in a filing to BSE. “We wish to inform all stakeholders that all the points mentioned in the letter are being addressed and we shall respond with complete details of our remedial actions to USFDA before the stipulated date,” it added.

On account of this, there is no disruption of our operations and “no revenue loss is envisaged”, the company
said. Shares of Vista Pharmaceuticals today closed at Rs 31.15 per scrip on BSE, down 4.89 per cent from its previous
close.

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