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Suven Life Sciences today said it has received the US health regulator’s approval for its active pharmaceutical ingredients (API) manufacturing facility at Pashamylaram in Andhra Pradesh.
“USFDA has classified Suven facility at Pashamylaram as acceptable for manufacture and supply of API and intermediates,” the Hyderabad-based company said in a filing to BSE.
The approval has been given after renewal inspection of the facility by the United States Food and Drug Administration under current good manufacturing practice.
“So far, Suven has filed 16 drug master files and one abbreviated new drug application from this facility,” Suven added.
Shares of Suven Life Sciences were being quoted at Rs 23.65 in late afternoon trade on BSE today, up 15.37 per cent from their previous close.
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