Page 8 - Lupin

Drug firm Lupin introduces smoking cessation generic product in US market

Drug firm Lupin on Wednesday said it has launched a product, used as an aid to smoking cessation treatment, in the US market. The company has launched Varenicline tablets in strengths of 0.5 mg and 1 mg, after having received approval from the US Food and Drug Administration (USFDA), the Mumbai-based drug maker said in a regulatory filing. The company's product is the generic equivalent of PF Prism CV's Chantix tablets, it added. It is indicated for use as an aid to smoking cessation treatment. As per the IQVIA data, Varenicline tablets had estimated annual sales of USD 412 million in the US. Shares of the company were trading 0.75 per cent up at Rs 1,406.50 apiece on the BSE.

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Stocks to Watch on January 10, 2024: The company reported 15 per cent YoY decline in Q3 consolidated revenue to Rs 231.7 crore. Net profit slumped 59 per cent to Rs 34.5 crore

Lupin gets USFDA approval to market generic medication to treat diabetes

Drug firm Lupin on Thursday said it has received approval from the US health regulator to market a generic medication to treat diabetes. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Dapagliflozin and Saxagliptin tablets, the Mumbai-based drug maker said in a regulatory filing. The company's product is a generic equivalent of AstraZeneca AB's Qtern tablets, it added. This generic product will be manufactured at its Pithampur facility, the company said. Dapagliflozin and Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As per IQVIA data, Dapagliflozin and Saxagliptin tablets had estimated annual sales of USD 5 million in the US market.

US pipeline to keep pharma major Lupin's revenues on healthy trajectory

The stock of pharma major Lupin is up 14 per cent over the last eight trading sessions and is trading at Rs 1,406 a share. The gains are on expectations that margins will improve

USFDA nod to Lupin for generic Loteprednol Etabonate ophthalmic suspension

Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Loteprednol Etabonate ophthalmic suspension indicated for temporary relief of seasonal allergic conjunctivitis. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Loteprednol Etabonate ophthalmic suspension, 0.2 per cent, Lupin said in a regulatory filing. It is a generic equivalent to the reference listed drug (RLD) Alrex ophthalmic suspension, 0.2 per cent of Bausch & Lomb Inc. The product will be manufactured at Lupin's Pithampur facility in India, the company added. Loteprednol Etabonate ophthalmic suspension, 0.2 per cent, is indicated for the temporary relief of signs and symptoms of seasonal allergic conjunctivitis. It had estimated annual sales of USD 29.1 million in the US market, Lupin said citing IQVIA MAT October 2023 data.

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Lupin expands global portfolio with acquisition of assets from Sanofi

The deal involves the acquisition of a portfolio of accretive established products in Europe and Canada

Lupin to acquire products in Europe, Canada from Sanofi for Rs 91 cr

Home-grown pharma major Lupin Ltd on Friday said it acquired a portfolio of established products in Europe and Canada from Sanofi for a purchase consideration of EUR 10 million (Rs 91 crore). Lupin Atlantis Holdings SA, Switzerland, a wholly-owned subsidiary of the company, has signed an asset purchase agreement with Sanofi, a French multinational pharmaceutical and healthcare company, for the purpose, Lupin said in a regulatory filing. The purchase consideration is EUR 10 million (Rs 91 crore) plus sales milestones up to EUR 8 million (Rs 72.8 crore), contingent upon future sales, it added. Under the agreement, Lupin will acquire brands AARANE in Germany and NALCROM in Canada and the Netherlands. The turnover of the said brands in these markets for the year ended March 31, 2023 was about USD 6.494 million (Rs 53.7 crore), the company said. "The proposed transaction is of strategic interest by bringing accretive assets in the respiratory field to help structure the company's new ..

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Sun Pharma, Lupin recall drugs in US market over manufacturing issues: FDA

Leading drugmakers Sun Pharma and Lupin are recalling products in the US market over manufacturing issues, as per the US Food and Drug Administration (USFDA). Mumbai-based Sun Pharmaceutical Industries is recalling 96,192 bottles of Liothyronine Sodium Tablets in the US that are used to treat an underactive thyroid, according to the latest enforcement report issued by the American health regulator. Princeton-based Sun Pharmaceutical Industries Inc, a unit of the company, is recalling the affected lot that was produced at the drugmaker's Dadra-based facility. The company is recalling the lot due to "failed impurities/degradation specifications", the USFDA stated. The company commenced the voluntary nationwide Class II recall on December 4, this year. USFDA stated that Mumbai-based Lupin is also recalling an unspecified number of penicillamine tablets in the US. The medication is used to treat rheumatoid arthritis and Wilson's disease. Baltimore-based Lupin Pharmaceuticals Inc, a u

Lupin Ltd receives USFDA approval for smoking cessation drug Chantix

The product will be manufactured at Lupin's Pithampur facility in India, the company said in a regulatory filing

Lupin announces launch of world's first FDC drug for chronic lung disease

Lupin Vilfuro-G is the only FDC that uniquely combines Vilanterol, Fluticasone Furoate, and Glycopyrronium Bromide for the long-term management and treatment of moderate to severe COPD

Lupin ties up with Amman Pharma for commercialisation of biosimilar product

Drug firm Lupin on Friday said it has tied up with Amman Pharma to market a biosimilar product in the Middle East region. The company has inked a licensing pact for the commercialisation and marketing of Ranibizumab, a biosimilar of Lucentis, in various countries including Saudi Arabia, UAE, Iraq and Lebanon. Ranibizumab is indicated for the treatment of patients with neovascular age-related macular degeneration, macular edema following retinal vein occlusion (RVO) and diabetic macular edema, among others. Shares of the company on Friday ended 2.04 per cent down at Rs 1,180.20 apiece on the BSE.

Lupin, Amman Pharma collaborates for exclusive marketing of Ranibizumab

Lupin Limited has partnered with pharmaceutical manufacturer Amman Pharmaceuticals Industries for exclusive marketing and commercialisation of Ranibizumab in the West Asian region

Lupin's net profit jumps nearly four-fold on strong US growth, stock up

US sales cross $200 million for the first time in two years, beat analyst expectations

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Stocks to watch on Thursday, November 09, 2023: Adani Ports Sri Lankan JV to get $553 mn funding from the US DFC. Patanjali, Phoenix Mills and Brigade Enterprises to react to strong jump in Q2 profit.

Lupin introduces generic version of Zemuron Injection in United States

The newly introduced Rocuronium Bromide Injection is available in two formulations

Lupin receives approval from the US FDA for its Selexipag for injection

In 2022, sales of the Selexipag Franchise in the US stood at $ 1.1 billion. The sales for January 1 to September 30, 2023, stood at $978 million

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Lupin receives tentative approval from US FDA for apalutamide tablets

Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and Active Pharmaceutical Ingredients (APIs) in over 100 markets