Page 22 - Lupin
Exposure to US market causing constant FDA scrutiny for big drug firms
Dr Reddy's was in the news for falling short of expectations during routine audits conducted by the US drug regulator
 "Exposure to US market causing constant FDA scrutiny for big drug firms")
Lupin launches generic drug in US for treatment, prevention of hypokalemia
The company had earlier received approval for the product from the United States Food and Drug Administration
 "Lupin launches generic drug in US for treatment, prevention of hypokalemia")
Nifty outlook and stock pick by Angel Broking: Buy Persistent, Lupin
Stock calls and Outlook on Nifty by Mr. Sameet Chavan, Chief Analyst- Technical & Derivatives, Angel Broking Ltd.
 "Nifty outlook and stock pick by Angel Broking: Buy Persistent, Lupin")
Anti-tuberculosis drug market continues to shrink for private firms
Lupin, the largest player in India's anti-TB market, too admitted that in anti-TB segment, the focus on branded business has declined in the past few years
 "Anti-tuberculosis drug market continues to shrink for private firms")
Uncertainty over US biz growth keeps Street cautious on Lupin stock
A strong product pipeline and growth in India and emerging markets are positives, but regulatory hurdles, delayed drug approvals in the US could hurt prospects
 "Uncertainty over US biz growth keeps Street cautious on Lupin stock")
We are growing our biosimilars capacity six-fold: Lupin MD Nilesh D Gupta
We were into APIs in the US and we started finished products, said Nilesh D Gupta
 "We are growing our biosimilars capacity six-fold: Lupin MD Nilesh D Gupta")
Active pharmaceutical ingredients focus helps drug firms offset slowdown
Besides captive consumption, the company also supplies APIs to external customers across international markets
 "Active pharmaceutical ingredients focus helps drug firms offset slowdown")
Lupin recalls more than 18,000 bottles of antibiotic drug in US market
The drug, cefdinir for oral suspension, has been manufactured by Lupin's Mandideep manufacturing facility in central India
 "Lupin recalls more than 18,000 bottles of antibiotic drug in US market")
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 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
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