Lupin gets observation in establishment inspection report from USFDA for Tarapur facility

Shares of Lupin were trading at Rs 854.00 per scrip on the BSE, up 1.09 percent from its previous close.

Press Trust of India November 27, 2018 13:56:38 IST
Lupin gets observation in establishment inspection report from USFDA for Tarapur facility

New Delhi: Drug firm Lupin on Tuesday said it has received an observation in the establishment inspection report (EIR) given by the US health regulator for its Tarapur facility in Maharashtra.

Lupin gets observation in establishment inspection report from USFDA for Tarapur facility

Representational image. Getty

The inspection, conducted by the United States Food and Drug Administration (USFDA) between 27 August and 31 August, concluded with an inspectional observation, Lupin said in a statement.

"For Lupin, meeting and exceeding global quality and procedural standards has always been paramount. We are committed to upholding the highest levels of quality and compliance standards across all our facilities," said Lupin Managing Director Nilesh Gupta.

Founded in 1992, the Tarapur facility manufactures active pharmaceuticals ingredients, the company said.

Shares of Lupin were trading at Rs 854.00 per scrip on the BSE, up 1.09 percent from its previous close.

Updated Date:

also read

Lupin gets establishment inspection report from USFDA for its Nagpur facility
Business

Lupin gets establishment inspection report from USFDA for its Nagpur facility

Earlier in May, in a regulatory filing Lupin had said that the US health regulator had completed inspection of the Nagpur facility without making any observations.

Lupin recalls over 11,000 bottles of hypertension drug in US market
Business

Lupin recalls over 11,000 bottles of hypertension drug in US market

Lupin's US arm is recalling 11,706 bottles of Lisinopril tablets, used for treating hypertension, from the American market, USFDA said.

Lupin to enter US HIV drug market after FDA green light
Business

Lupin to enter US HIV drug market after FDA green light

The company's product is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection, it said.