Page 12 - Lupin

Pharma major Lupin gets establishment inspection report from USFDA

Lupin Limited received an inspection classification of "No Action Indicated" (NAI) after the inspection, which was conducted between March 6 to March 10

Pharma major Lupin receives approval from US FDA for diazepam rectal gel

Diazepam Rectal Gel had estimated annual sales of $34 million in the US

Lupin extends gain, hits 52-wk high post Q4 results; surges 20% in 1 month

Analysts believe the stock is factoring margin recovery and certain niche launches in the US.

Sensex climbs 179 pts in fag-end, Nifty tops 18,300; auto, bank stocks lead

CLOSING BELL: The fag-end rally was powered by IndusInd Bank, Bajaj Finance, Tata Motors, Reliance Industries, HDFC Bank, Maruti Suzuki, and Bajaj Finserv

Lupin reports 12% rise in Q4 sales riding on API, US and India biz

The revenue growth came from a strong API business performance along with US and domestic market sales growth

Lupin to acquire French pharma company Medisol for around Rs 160 crore

The company has entered into a definitive agreement to acquire the entire share capital of Medisol, subject to approval from the French Ministry of Economy and Finance

Lupin Diagnostics launches regional reference laboratory in Bengaluru

After establishing a presence in Hyderabad, this launch expands footprint in South India

We can raise money in our new venture firms in future, says Lupin MD

In a digital health venture, I would love to go into areas where we have equity with doctors. Respiratory is one area where I am very interested in, says Nilesh Gupta, MD, Lupin

USFDA issues Form-483 with 10 observations to Lupin's Pithampur plant

Drug firm Lupin on Thursday said the US health regulator has issued a Form-483 with ten observations after inspecting its Pithampur Unit-2 manufacturing facility. The US Food and Drug Administration (USFDA) inspected the plant from March 21 to March 29, 2023. The inspection closed with issuance of a Form-483 with ten observations, Lupin said in a regulatory filing. "We are addressing the observations comprehensively and will work with the US FDA to resolve these issues at the earliest," it added. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility. In October 2022, the drugmaker announced that the US health .

Lupin gets tentative USFDA approval to market generic valbenazine capsules

Pharmaceuticals firm Lupin Ltd on Monday said it has received tentative approval from the US health regulator to market its generic valbenazine capsules used to treat involuntary movements of the face, tongue or other body parts. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of valbenazine capsules of strengths 40 mg, 60 mg and 80 mg, the company said in a regulatory filing. These are the generic equivalent of Ingrezza capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc, it added. Valbenazine capsules had estimated annual sales of USD 1,235 million in the US, the company said, citing IQVIA MAT December 2022 data.

Stocks to watch: Tata Steel, BEL, Paytm, Zydus Life, Crompton Greaves, NBCC

Stocks to watch: From Tata Steel to Bharat Electronics, here are few stocks likely to see action in Monday's trading session

Stocks to Watch: RVNL, BEL, HAL, Campus Activewear, Vedanta, PNB, IT cos

Stocks to Watch: IT stocks may remain in focus as Accenture reported a revenue of $15.81 bn in Q2, beating its guidance of $15.2-15.75 bn. The giant also announced it will lay off 19,000 employees

Stocks to Watch: Tata Motors, IOC, Hind Zinc, Sonata Software, Bandhan Bank

Stocks to Watch: Tata Motors will increase prices of its commercial vehicles (CV) range by 5 per cent starting April 1, in what would be its fourth such price hike this fiscal year

Lupin gets approval for generic medicine for schizophrenia, depression

Pharmaceuticals firm Lupin Ltd on Tuesday said it has received approval from the US health regulator for its generic Brexpiprazole tablets used to treat the symptoms of schizophrenia and depression. The approval granted by the US Food and Drug Administration (US FDA) is for the abbreviated new drug application for Brexpiprazole tablets of strengths 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, the company said in a regulatory filing. These are generic equivalent of Rexulti tablets of Otsuka Pharmaceutical Company Ltd, it added. "This product would be manufactured at Lupin's Pithampur facility in India," the company said. Lupin said Brexpiprazole tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, had an estimated annual sales of USD 1,575 million in the US, citing IQVIA MAT December 2022 data.

Sensex sheds 338 pts, Nifty ends near 17,050; IT, Adani Group stocks tumble

Stock market live updates: As of 7:45 am, the SGX Nifty stood at 17,208 levels, up 28-odd points

Stocks to watch: Lupin, GAIL, PNB Housing, Shriram Finance, Axita Cotton

Stocks to watch today: From Lupin to Gail (India), here are stocks to watch out in Tuesday's trading session

Sensex crashes 928 pts, ends below 60K; Nifty near 17,550 amid global rout

CLOSING BELL: The market cap of Adani Group companies fell below Rs 8-trillion-mark in Wednesday's intra-day trade, down from Rs 25 trillion recorded before the release of the Hindenburg report

Lupin Pharma launches Lurasidone Hydrochloride Tablets in US

The generic equivalent of Latuda tablets has been launched in the US markets

Brokerages downgrade Lupin post weak Q3; see up to 17% downside

Lupin shares fell 7.5 per cent to Rs 681 apiece on the BSE in the intra-day trade

Drug marker Lupin reports 72% decline in Q3 net profit to Rs 153 cr

Drug maker Lupin has reported 72 per cent decline in consolidated net profit at Rs 153 crore for the third quarter ended December 31, 2022. The company had reported a net profit of Rs 545 crore for October-December period last fiscal. Total revenue from operations however increased to Rs 4,322 crore as compared with Rs 4,161 crore in the year-ago period, the company said in a statement. "Sales in the US have improved on the back of new product launches and the brand acquisition we made during the quarter. Excluding the impact of genericization on our diabetes portfolio, the India business has performed in line with the market," Lupin's Managing Director Nilesh Gupta stated. With the recent sales force expansion and new product launches, the company expects to be back to above-market growth, he added. Shares of the company were trading 3.74 per cent down at Rs 745.10 apiece on the BSE.