Page 12 - Lupin

Lupin recalls over 16,000 bottles of generic tuberculosis drug in US

Drug maker Lupin is recalling 16,056 bottles of Rifampin Capsules, used in the treatment of all forms of tuberculosis, in the US market due to a manufacturing issue, according to the US Food and Drug Administration. As per the latest Enforcement Report by the US health regulator, Lupin Pharmaceuticals Inc, a US-based arm of the Mumbai-based drug major, is recalling the affected lot due to "Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study." The affected lot has been produced at Lupin's Aurangabad plant and marketed in the US by Baltimore-based Lupin Pharmaceuticals. The company initiated Class II nationwide (US) recall of the affected lot on December 12 last year. As per the US Food and Drug Administration (USFDA), a class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability

Lupin launches combination drug for patients with heart failure conditions

The company said it has introduced Sacubitril and Valsartan under two brand names, Valentas and Arnipin, in strengths of 200 mg, 100 mg, and 50 mg, in India

Lupin gets USFDA tentative nod for generic drugs to treat HIV infection

Pharmaceutical firm Lupin on Monday said it has received tentative approval from the US health regulator to market its generic version of Dolutegravir and Rilpivirine tablets used in treatment of HIV infection. The tentative approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, Lupin said in a regulatory filing. The Dolutegravir and Rilpivirine tablets, 50 mg/25 mg had estimated annual sales of USD 666 million in the US, the company said citing IQVIA MAT September 2022 data.

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.