Page 22 - Lupin

Lupin's Goa plant may face regulatory action, says USFDA after inspection

Lupin said in a regulatory filing that the US health regulator had made two observations following the inspection and had classified the inspection as Official Action Indicated

Lupin slips 5% as USFDA classifies Goa facility's inspection as OAI

The USFDA stated that Goa facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed.

Lupin's Q4 disappoints on soft India sales, higher tax and interest costs

Analysts remain neutral on the stock given limited growth visibility in US, regulatory and lawsuit overhangs

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 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'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, 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

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

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

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 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: Street waits for progress on new launches, resolution of plants

Growth depends on key regulatory approvals

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.