Lupin gets EIR for Mandideep facility from USFDA

Lupin Limited has received an establishment inspection report (EIR) after closure of USFDA inspection of its Mandideep Unit II facility, classifying the inspection as voluntary action indicated.

The inspection at the facility was carried out by USFDA between November 26 and December 4, 2018. Lupin’s Mandideep facility (Madhya Pradesh) is its important cardiovascular API manufacturing facility.

This week, the company had received another EIR from USFDA for its Nagpur facility. The inspection for the facility was carried out by USFDA between January 6 and January 10, 2020. Nagpur facility is Lupin’s largest and the most-advanced oral solid dosage facility.

Last week, the company had successfully launched Mycophenolic Acid delayed-release tablets USP, 180 mg and 360 mg. Mycophenolic Acid delayed-release tablets USP, 180 mg and 360 mg, is the generic equivalent of Myfortic delayed-release tablets, 180 mg and 360 mg of Novartis Pharmaceuticals Corporation.

Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in US, India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

On Wednesday, the stock of Lupin opened gap up 2.3 per cent at Rs 845 from its previous close of Rs 825.95 on BSE.