The CHMP's positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU), the Mumbai-based firm added
Japanese subsidiaries of Lupin produce treatments in therapeutic areas, including psychiatry and neurology
Shares of Lupin were today trading at Rs 903 per scrip on BSE, down 0.07 per cent from its previous close
North America sales fall by a quarter, indicating intense pricing pressures
The unit was inspected by United Kingdom's Medicines and Healthcare products Regulatory Agency in March 2018 and there were no critical or major observations cited
The two drugs, Gibtulio Met and Ajaduo, will be co-marketed simultaneously by Boehringer Ingelheim and Lupin across India under different brand names
In past one month, Lupin has outperformed the market by surging 23% as compared to 1.4% rise in the S&P BSE Sensex.
Lupin's Japan story assumes significance as it held on to the highly regulated market, when most of its Indian peers quit
Under the terms of the agreement, Lupin will receive an up-front payment of $15 million and potential commercial milestones together with an equal share in net profits of the product.
Etanercept is used in treatment of auto immune diseases such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis and ankylosing spondylitis
Lupin's product is the generic equivalent of Novartis Pharmaceuticals Corp's Methergine
But the going is still tricky
At 10:41 am; the stock was trading 3% higher at Rs 808 after rallied 7% to Rs 843 on the NSE in intra-day trade
The stock was up 3% to Rs 798, extending its Monday's 5% surge on the BSE
US Food and Drug Administration's warning letters to two Lupin plants in Goa and Indore in November was the main reason for the decline in the stock price
The stock hit 52-week low of Rs 782, down 2.5% in intra-day trade, extending its previous day's 6% decline on BSE
Gross profit margins fell to a 16-quarter low, pulling down earnings by 65% y-o-y
The stock moved higher by nearly 2% to Rs 852, extending its past three days 3.5% gain on the BSE
While the company can continue to supply existing products to the US market, fresh approvals will be delayed.
The stock tanked 15% to Rs 880 on the BSE, trading at its lowest level since January 1, 2014.