Mumbai based Lupin produces and develops a wide range of branded & generic formulations, biotechnology products and APIs globally
Company's US arm Lupin Pharmaceuticals Inc is initiating the recall
Anti-bacterial injection Ceftriaxone are being recalled due to violation of current good manufacturing norms
Lupin further said that the company shall commence promoting the products in the US shortly
Overall, between Lupin and Gavis combined, over 160 products filings are pending for approval with USFDA
Earlier, both the plants had received adverse observations from the US drug regulator
In March, Lupin received nine adverse observations from US drug regulator at its Goa plant and the company expects resolution in the next 3-6 months
The stock dipped almost 8% to Rs 1,525 on the BSE in early morning trade on the BSE.
Interview with CEO, Lupin
Total revenue grew 34% to Rs 4,091 cr
Diabetics products boost US growth; India, Japan, others add to Street beating performance
Company's CFO said launch of Methergine oral tablets will have a positive impact on Lupin's US revenues
The company has re-introduced Methergine Oral tablets 0.2mg for the management of PPH
The drug, Methergine, is the only FDA approved oral uterotonic and Lupin has created of a specialised sales force to drive product sales
The product is generic version of Warner Chilcott's Femhrt tablets in the same strengths, Lupin said
The US arm has launched Zolpidem Sublingual Tablets, 1.75mg & 3.5mg used for treatment of insomnia
Reacting to the news, stock of Lupin was trading at Rs 1,465.30 on BSE, up 0.27% from the previous close
Stocks fell for a second day in volatile trading, as drugmakers countered advances in automakers before the expiry of the monthly derivatives series on Thursday
Audit was conducted at Mandideep location; observations received are minor in nature and will not lead to disruption of product supply
At 10:43 AM, the Nifty Pharma index was down 4% as compared to a marginal 0.14% decline in the Nifty 50 index