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Business News/ Industry / Manufacturing/  Divi’s Laboratories gets five observations from USFDA
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Divi’s Laboratories gets five observations from USFDA

USFDA issued a Form 483 with five observations to Divi's Laboratories for its active pharmaceutical ingredient plant in Visakhapatnam

Shares of Divi’s rose 0.91% to close at Rs1163.60 on BSE.Premium
Shares of Divi’s rose 0.91% to close at Rs1163.60 on BSE.

Hyderabad: Drug maker Divi’s Laboratories Ltd on Wednesday said it got five observations from the US Food and Drug Administration (USFDA) for its active pharmaceutical ingredient plant called Unit-II in Visakhapatnam.

USFDA inspected the plant from 29 November to 6 December, the company said in a statement to stock exchanges on Wednesday.

“We have been issued a Form 483 with five observations and these shall be responded within the time permitted," Divi’s said.

The company did not disclose the nature of those observations.

Divi’s Unit-II plant at Visakhapatnam is located at Chippada village, about 35 km north of the port city.

Divi’s is engaged in the manufacturing of generic active pharmaceutical ingredients or the key raw materials that go into manufacture of formulation drugs, custom synthesis of active ingredients for innovator companies, other speciality chemicals and nutraceuticals.

The US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly. If the company fails to meet the regulator’s expectations, a warning letter may be issued.

Shares of Divi’s rose 0.91% to close at Rs1163.60 on BSE, while the benchmark Sensex declined 0.59% to 26,236.87 points.

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Published: 08 Dec 2016, 01:12 AM IST
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