Page 2 - Lupin

Lupin gets US FDA nod for generic medicine to treat heart ailments

Pharmaceuticals firm Lupin Ltd on Tuesday said it has received approval from the US health regulator for its generic version of Prasugrel tablets. The medicine is indicated to prevent other serious heart and blood vessel problems in patients with recent heart attacks, strokes and blood clots in stents. The approval by the US Food and Drug Administration (US FDA) for the Abbreviated New Drug Application (ANDA) of Prasugrel tablets of strengths 5 mg and 10 mg, the company said in a regulatory filing. These are the generic equivalent of Effient tablets, 5 mg and 10 mg of Cosette Pharmaceuticals, Inc. "The product will be manufactured at Lupin's facility in Goa, India," it added. Prasugrel Tablets 5 mg and 10 mg had estimated annual sales of USD 18 million in the US, Lupin said citing IQVIA MAT September 2022 data.

Lupin launches fixed-dose triple drug combination to manage asthma

Pharmaceuticals firm Lupin Ltd on Thursday said it has launched a fixed-dose triple drug combination of Indacaterol, Glycopyrronium and Mometasone for managing asthma. The product launched under the brand name DIFIZMA is being offered as a dry powder inhalation, the company said in a regulatory filing. "DIFIZMA is the only FDC (fixed-dose combination) that has been approved by the Drug Controller General of India (DCGI) for the treatment of inadequately controlled asthma," it said. The product will help in the management of inadequately controlled asthma by improving lung function, providing better symptom control and reducing exacerbations. The drug will be available in one strength with a fixed-dose to be taken once daily, the company added. Lupin India Region Formulations President Rajeev Sibal claimed that DIFIZMA is a first-of-its-kind novel combination product available in India. It is aimed at catering to the unmet need of patients with inadequately controlled asthma and al

Sensex slumps 981 pts, Nifty ends near 17,800; PSU index crashes 6%

Market at close: The pain was even more severe in the broader market space where the BSE MidCap and SmallCap indices fell 3 and 4 per cent, respectively

Pharma stocks upbeat amid Covid-19 scare; Divi's, Lupin can gain up to 10%

Technically, the Nifty Pharma index needs to immediate hurdle at 13,500, for further upside to 14,250.

Stocks to Watch: Aban Holdings, Landmark Cars, RIL, Lupin, Gail, JK Cement

Stocks to Watch Aban Holdings and Landmak Cars will be debuting on the stock exchanges on Friday. Both these stocks are likely to witness a tepid start to trade.

Lupin set to gain market share in US flu season; shares up 6% in 2 sessions

The stock has underperformed peers and the benchmark over the past year

Lupin Pharma's US-based arm recalls blood pressure tablets in US market

Pharmaceuticals firm Lupin Ltd on Thursday said its US-based arm is recalling four lots of Quinapril tablets used to treat high blood pressure due to the presence of a nitrosamine impurity. Lupin Pharmaceuticals Inc, the company's wholly-owned arm, is recalling the said tablets due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the acceptable daily intake (ADI) level, Lupin Ltd said in a regulatory filing. "To date, Lupin has received no reports of illness that appear to relate to this issue," it said, adding it discontinued marketing of Quinapril tablets in September 2022. Quinapril tablets of strengths 20mg and 40mg packaged in separate 90 count bottles were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets, it added. The filing further said Lupin Pharmaceuticals Inc is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and throug

Stocks to watch: Glenmark Pharma, NTPC, V-Guard Inds, Lupin, YES Bank, NDTV

Stocks to watch today: Jaiprakash Associates has called a board meeting on Monday, December 12, to mull over sale of their Nilgrie cement unit in Madhya Pradesh

Lupin to enter cardio-vascular therapeutics space in 10 cities by Feb

Move will mark firm's digital healthcare foray 18 months after announcement; firm also plans to enter mental and respiratory illness segments, cover 28-30 cities by CY 2023-end

After the anti-diabetic market, India's cardiac market in for a shake-up

After the anti-diabetic market, India's cardiac market in for a shake-up

Stocks to Watch: HCL Tech, Lupin, Fusion Micro Fin, Five-Star, NBCC, PNB

Stocks to Watch Today: Newly listed Fusion Micro Finance and Five-Star Business are likely to be in focus on the back of strong Q2 performance reported by the companies.

Stocks to Watch: PNB, Tube Investments, Indian Oil, Laurus Labs, SBI, Lupin

Stocks to Watch: Punjab National Bank (PNB) on Thursday said it received the government's approval to divest its entire stake (15.22 per cent) in UTI Asset Management Company

World in turmoil, domestic pharma firms target India for healthy growth

Share of India revenue in home-grown firms' consolidated turnover rising over the years

Stocks to Watch: Reliance, Nykaa, NDTV, Kaynes Technology, PFC, JK Paper

Stocks to Watch: Kaynes Technology will make its debut today. The issue price is fixed at Rs 587 per share

Mehul Kothari expects Ashok Leyland to break its all-time high; Check why

According to the technical analyst from Anand Rathi, Ashok Leyland can potentially break its all-time high at Rs 169.45, while he is also bullish on Lupin.

Lupin posts net profit of Rs 130 cr in Q2, revenue rises to Rs 4,145 cr

Drug maker Lupin on Wednesday said its consolidated net profit stood at Rs 130 crore for the second quarter ended September 30, 2022. The Mumbai-based company had reported a net loss of Rs 2,098 crore in the July-September period of the previous fiscal. Total revenue from operations rose to Rs 4,145 crore for the period under review as compared to Rs 4,091 crore in the year-ago period, Lupin Ltd said in a regulatory filing. The company said it paid Rs 1,878 crore towards litigation and settlement related expenses last year with respect to antitrust class action filed in the US in connection with the drug Glumetza. "We have performed in line with our expectations during the quarter, and are on the path of steady growth in sales and profitability. Our sales growth sequentially was robust as our US business bounced back. "Our India business delivered continued growth in line with the market, excluding the impact of loss of exclusivity and certain sales in the diabetes and cardiovascu

Drug firm Lupin gets USFDA nod to market generic antibiotic medicine in US

Drug firm Lupin on Tuesday said it has received approval from the US health regulator to market Doxycycline Capsules used to treat bacterial infections in the American market. The drug firm has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Doxycycline Capsules, 40 mg, a generic equivalent of Galderma Laboratories' Oracea capsules, Lupin Ltd said in a statement. As per IQVIA MAT September 2022 data, Doxycycline capsules had estimated annual sales of USD 215 million in the US market.

Lupin gets US drug regulator's nod for generic oral contraceptive pill

Drug maker Lupin on Friday said it has received approval from the US health regulator to market Drospirenone tablets, used to prevent pregnancy, in the American market. The company has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA), Drospirenone Tablets in 4 mg strength, the Mumbai-based drug maker said in a statement. The company's product is the generic equivalent of Exeltis USA Inc's Slynd tablets, it added. As per IQVIA MAT September 2022 data, Drospirenone tablets had estimated annual sales of USD 141 million in the US market.

Sensex recoups 350pts from day's low, ends flat; Nifty holds 18K; SBI up 2%

CLOSING BELL: IT, Power stocks logged significant losses, even as select financial stocks gained.

USFDA issues warning letter to Lupin for Maharashtra-based API plant

The US health regulator has pulled up drug maker Lupin for manufacturing lapses, including failure to establish adequate written procedures for cleaning equipment, at its Maharashtra-based plant. In a warning letter, the US Food and Drug Administration (USFDA) has pointed out various lapses at the Tarapur (Thane) plant which produces active pharmaceutical ingredients (API). "This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API)," the US health regulator said. It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated..." The USFDA inspected the manufacturing facility from March 22 to April 4, 2022. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. In the warning letter the health regulator pointed out the company