In February 2018, YL Biologics had announced completion of the global phase III study of their biosimilar Etanercept
'Official Action Indicated' means approvals of pending applications or supplements from this site maybe withheld
The company has slipped to being the seventh-largest pharma company in terms of market cap
The product is being recalled by Baltimore-based Lupin Pharmaceuticals Inc, a subsidiary of the company
Govt had in September 2018 banned 344 FDC drugs, including Lupin's combo for diabetics, citing lack of therapeutic justification
While the actual Dec quarter revenue was much more than estimates, the same was due to higher licensing income
The product is a generic version of AbbVie Inc's Synthroid tablets in the same strengths
The drug is manufactured by Novel Laboratories Inc for Baltimore-based Lupin Pharmaceuticals, Inc
The pharma major acquired a portfolio of central nervous drug system drugs, including NaMuscla, through its acquisition of German drug maker Temmler Pharma in 2015
Growth depends on key regulatory approvals
The drug maker will earn over $1 billion in fee, milestone payments, royalties from US firm
A total fine of 315 million Euros have been upheld on six companies.
Chronic therapies refer to drugs for ailments which are chronic in nature such as diabetes, hypertension, etc
The stock dropped 4.13 per cent to end at Rs 852.20 on the BSE. Intra-day, it declined 4.49 per cent to Rs 849
Most neighbouring countries recognise the Brazilian drug regulator's approvals
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