Page 21 - Lupin

Market Ahead, February 3: Top factors that could guide markets this week

On the corporate earnings front, Bharti Airtel, Lupin, Sun Pharma, and Mahindra & Mahindra are among the major companies scheduled to declare their October-December results this week

USFDA classifies inspection of Lupin unit as 'Official Action Indicated'

Official Action Indicated means 'objectionable conditions were found and regulatory administrative sanctions by FDA are indicated' during inspections

Lupin dips 2% as USFDA classifies Tarapur unit as Official Action Indicated

The company, however, said it does not believe that this inspection classification will have an impact on disruption of supplies or the existing revenues from operations of this facility.

Nifty view & two stocks that Sameet Chavan of Angel Broking is bullish on

Stock calls and Outlook on Nifty by Mr. Sameet Chavan, Chief Analyst- Technical & Derivatives, Angel Broking Ltd.

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

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

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.

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

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

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

Active pharmaceutical ingredients focus helps drug firms offset slowdown

Besides captive consumption, the company also supplies APIs to external customers across international markets

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'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