Page 12 - Lupin
Lupin gets four observations from USFDA for pharmacovigilance inspection
Drug firm Lupin Tuesday said it has received four observations in the establishment inspection report (EIR) given by the US health regulator following the closure of pharmacovigilance inspection. "The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin's marketed products worldwide. The inspection closed with four observations," the company said in a regulatory filing. Lupin has received the EIR from the United States Food and Drug Administration (USFDA) for the post-marketing adverse drug experience (PADE) inspection, indicating successful closure of the inspection, the filing added. The inspection was conducted at its global pharmacovigilance group DSRM (Drug Safety & Risk Management) based out of Mumbai between January 14-18, 2019, Lupin said. The USFDA issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection following the closure of the inspection. Shares of Lupin Ltd were trading
 "Lupin gets four observations from USFDA for pharmacovigilance inspection")
Lupin gets govt nod for more time to complete project in Indore SEZ
The company is setting up its pharma unit in Indore SEZ to manufacture pharmaceutical formulations metered dose inhalers and dry powder inhalers
 "Lupin gets govt nod for more time to complete project in Indore SEZ")
Lupin's Pithampur facility may face regulatory action, says USFDA
The Mumbai-based drug maker, however, said it does not believe that the classification would have an impact on disruption of supplies or the existing revenues from operations of this facility
Lupin gets USFDA nod to market gel that treats low testosterone in men
The company's product is a generic version of AbbVie Inc's AndroGel 1.62 per cent, it added.
Lupin recalls over 12,000 cartons of birth control pills from US
The product was manufactured by Lupin Ltd at its Pithampur facility in Madhya Pradesh
 "Lupin recalls over 12,000 cartons of birth control pills from US")
Lupin, YL Biologics get nod to market rheumatoid arthritis drug in Japan
In February 2018, YL Biologics had announced completion of the global phase III study of their biosimilar Etanercept
 "Lupin, YL Biologics get nod to market rheumatoid arthritis drug in Japan")
USFDA classifies Lupin's Somerset facility as 'Official Action Indicated'
'Official Action Indicated' means approvals of pending applications or supplements from this site maybe withheld
 "USFDA classifies Lupin's Somerset facility as 'Official Action Indicated'")
Latest FDA action is a 'sentimentally negative outcome' for Lupin
The company has slipped to being the seventh-largest pharma company in terms of market cap
 "Latest FDA action is a 'sentimentally negative outcome' for Lupin")
Lupin recalls 43,860 ophthalmic solution bottles in US over impurities
The product is being recalled by Baltimore-based Lupin Pharmaceuticals Inc, a subsidiary of the company
Delhi HC sets aside govt ban on Lupin FDC, refers matter back to Drug Board
Govt had in September 2018 banned 344 FDC drugs, including Lupin's combo for diabetics, citing lack of therapeutic justification
Lupin registers tepid growth in India revenues, US sales remain subdued
While the actual Dec quarter revenue was much more than estimates, the same was due to higher licensing income
 "Lupin registers tepid growth in India revenues, US sales remain subdued")
Lupin gets USFDA approval to market hypothyroidism treatment drug
The product is a generic version of AbbVie Inc's Synthroid tablets in the same strengths
Lupin recalls over 23,000 bottles of antibiotic drug for being sub-potent
The drug is manufactured by Novel Laboratories Inc for Baltimore-based Lupin Pharmaceuticals, Inc
Lupin plans expansion, eyes Europe growth via acquisitions and launches
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
 "Lupin plans expansion, eyes Europe growth via acquisitions and launches")
Lupin: Street waits for progress on new launches, resolution of plants
Growth depends on key regulatory approvals
 "Lupin: Street waits for progress on new launches, resolution of plants")
Lupin ties up with US-based AbbVie for cancer drug, to earn $ 1 billion
The drug maker will earn over $1 billion in fee, milestone payments, royalties from US firm
European court upholds fine against drugmakers Lupin and Unichem
A total fine of 315 million Euros have been upheld on six companies.
 "European court upholds fine against drugmakers Lupin and Unichem")
Lupin plans expansion, eyes product purchase in chronic and acute therapy
Chronic therapies refer to drugs for ailments which are chronic in nature such as diabetes, hypertension, etc
Lupin shares fall over 4% after company's Q2 net profit dropped 41.5%
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
Lupin to develop Brazil as Latin American manufacturing, export hub
Most neighbouring countries recognise the Brazilian drug regulator's approvals
 "Lupin to develop Brazil as Latin American manufacturing, export hub")
