Lupin: Pithampur Unit III secures EIR from USFDA

The pharma company was issued an Establishment Inspection Report (EIR) for its Pithampur Unit-3 plant located near Indore, Madhya Pradesh, the company announced on Tuesday.

The inspection of the Pithampur Unit-3 was held between October 8 to 18, 2018. The plant engages in the manufacture of Metered Dose Inhalers (MDIs), Dry Powder Inhalers (DPIs) and topical formulations for the regulated markets including the US, the UK, EU, Japan and Australia. The clearance from USFDA will help the company launch important MDIs and DPIs in these markets.

Earlier last week, Lupin's US-based subsidiary had recalled 3,200 bottles of Testosterone Topical Solution in the US, following issues with the container. Also, on Monday, the company received USFDA approval to market its generic Tadalafil Tablets for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH).

On Tuesday, at 11:23 hours, the stock of Lupin Limited was trading at Rs. 779.70 per share, up by Rs. 13.50 or 1.76 per cent on NSE. The stock opened at Rs. 767.00 and hit an intraday high of Rs. 783.65 and a low of Rs. 759.05 per share.