Granules Jeedimetla plant gets EIR from USFDA

Granules Jeedimetla plant gets EIR from USFDA

Granules India has received an Establishment Inspection Report (EIR) from USFDA.

The Dollar Business Bureau

Granules India Ltd. on Monday announced that its Jeedimetla plant in Telangana has got an establishment inspection report (EIR) from the US health regulator, United States Food and Drug Administration (USFDA).

"The company has received the Establishment Inspection Report from United States Food and Drug Administration for the inspection conducted at its Jeedimetla facility in December 2015," Granules said in a statement.

Earlier, the USFDA had acknowledged receipts of responses that the company sent on January 7 and March 28 this year on the observations issued by the FDA for the facility. Acting on those responses, the USFDA had closed the matter and announced the EIR for the Jeedimetla facility.

On Monday, the shares of Jeedimetla were trading at around Rs.135.75 per scrip, up 5.52% from the last close of Rs.128.65.

Granules India had declared, in a regulatory filing in December 2015, that the US health regulator had completed the inspection at Jeedimetla in Telangana and at Vizag in Andhra Pradesh.

Granules Jeedimetla plant manufactures active pharmaceutical ingredient (API) of anti-diabetic drug metformin, anti-pain methocarbamol and expectorant drug guaifenesin.

The company boasts of its manufacturing footprints in India and China, while serving customers across more than 60 countries.

 

The Dollar Business Bureau - May 31, 2016 12:00 IST