Page 9 - Lupin

Lupin gets EIR Status from US FDA for Nagpur Unit-1 manufacturing facility

The EIR was issued following the facility's inspection conducted in July 2023

Lupin inks pact to acquire five legacy brands from Menarini Group

Lupin has secured the rights to five brands - Piclin, Menoctyl, Sucramal O, Pyridium and Distaclor

Lupin acquires five legacy brands from Meranini to solidify its portfolio

Lupin has already been marketing these brands in India since July 2021 under an agreement with A Menarini India Private Limited but will now have the full trademark ownership of the five brands

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Stocks to watch on Tuesday, September 12, 2023: From L&T raising its share buyback price, Bajaj Finance planning to enter new car loans segment, Power Grid to trade ex-bonus and more.

Lupin to sell generic respiratory drugs on Mark Cuban's online pharmacy

The partnership with Cuban-backed Cost Plus Drugs is expected to bolster Lupin's U.S. business, which already accounts for nearly 33% of its 2023 revenue

J&J, Lupin cut prices for tuberculosis drug in lower-income countries

(Reuters) - Johnson & Johnson and Indian drugmaker Lupin will supply their versions of the tuberculosis drug bedaquiline at a significantly cheaper price in low- and middle-income countries, a global anti-tuberculosis group said on Wednesday.

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Lupin gets USFDA nod to market generic lung disease treatment capsule

Pharma major Lupin Ltd on Tuesday said it received approval from the US health regulator to market its generic Pirfenidone capsules used for the treatment of lung disease known as idiopathic pulmonary fibrosis. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Pirfenidone capsules of 267 mg strength, Lupin said in a regulatory filing. The drug is the generic equivalent of Esbriet Capsules, 267 mg of Hoffmann La Roche Inc. This product will be manufactured at Lupin's Pithampur facility in India, it added. Pirfenidone capsules had estimated annual sales of USD 95 million in the US, Lupin said citing IQVIA MAT June 2023 data.

Lupin receives USFDA approval for generic blood pressure lowering drug

Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Metoprolol Succinate extended-release tablets used for lowering blood pressure. The approval by the US Food and Drug Administration (USFDA) for the abbreviated new drug application is for Metoprolol Succinate extended-release tablets of strengths 25 mg, 50 mg, 100 mg, and 200 mg, Lupin said in a regulatory filing. These are generic equivalent of Toprol-XL Tablets of Sequel Therapeutics, LLC. This product will be manufactured at Lupin's Pithampur facility in India, the company said. Metoprolol Succinate extended-release tablets had an estimated annual sales of USD 305 million in the US, the company said citing IQVIA MAT June 2023 data.

Pharma major Lupin gets USFDA approval for its generic antibiotic

Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator to market its generic antibiotic Doxycycline Hyclate delayed-release tablets used to treat bacterial infections. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Doxycycline Hyclate delayed-release tablets of strengths 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, Lupin said in a regulatory filing. This product will be manufactured at Lupin's Pithampur facility in India, it added. Doxycycline Hyclate Delayed-Release tablets had estimated annual sales of USD 9 million in the US, the company said citing IQVIA MAT June 2023 data.

Lupin hits 2-year high on strong Q1 results; zooms 66% since April

With clearance of Pithampur Unit-2, the company expects to add product approvals for the US region

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Stocks to Watch today, August 4: 2023: Food aggregator platform Zomato turned profitable for the first time ever in Q1FY24

Lupin gets USFDA approval to market generic skin treatment medication

Lupin on Wednesday said its American subsidiary has received an approval from the US health regulator to market a generic product used for treatment of skin issues. New Jersey-based Novel Laboratories Inc has received the approval from the US Food and Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, Lupin said in a statement. The product is the generic version of Hill Dermaceuticals Inc's Derma-Smoothe/FS Topical Oil. Lupin said the product will be manufactured at its Somerset facility in the US. As per the IQVIA MAT March 2023 data, Fluocinolone Acetonide Topical Oil had estimated annual sales of USD 9 million in the US. Lupin shares were trading 0.67 per cent down at Rs 981.65 apiece on the BSE.

Lupin announces USFDA warning letter resolution for Goa, Pithampur plants

Drug maker Lupin on Thursday said it has resolved manufacturing issues raised by the US health regulator regarding its Goa and Pithampur-based manufacturing facilities. The company has received a correspondence from the US Food and Drug Administration (USFDA) that it (Lupin) has now addressed the concerns raised in the warning letter for its facilities in Goa and Pithampur Unit-2, the drug firm said in a statement. This comes after the satisfactory evaluation of the corrective actions taken by the company in response to the Warning Letter issues by the USFDA on November 6, 2017, it added. "We are pleased to be informed by the USFDA that we have addressed the concerns through our corrective actions related to the November 2017 warning letter. We are committed to being compliant with good manufacturing practices, and to uphold global quality standards and ensuring the quality of our products," Lupin MD Nilesh Gupta said. A warning letter is issued when the US health regulator finds t

Lupin's subsidiary, Generic Health gets Tiotropium 18 micrograms approval

The company has received the approval from Therapeutic Goods Administration (TGA)

In-home cardio care: Lupin Digital, American College of Cardiology tie up

The aim is to give patients and healthcare providers tools to manage heart diseases at home and reduce rehospitalisation

Lupin gets thumbs up from USFDA to market generic medication in US

Drug firm Lupin on Friday said its unit has received approval from the US health regulator to market a medication to treat various disorders like schizophrenia. The company's Somerset-based wholly-owned subsidiary Lupin Inc has received approval from the US Food and Drug Administration (USFDA) for Chlorpromazine Hydrochloride tablets, Lupin said in a statement. The Mumbai-based drug maker's product is the generic version of Upsher-Smith Laboratories, LLC's product. As per IQVIA MAT data, Chlorpromazine Hydrochloride Tablets had an estimated annual sale of USD 45 million in the US.

Lupin gets USFDA establishment inspection report for Pithampur facility

Drug firm Lupin on Tuesday said it has received an Establishment Inspection Report from the US health regulator for its Pithampur Unit-2 manufacturing facility. The Establishment Inspection Report (EIR) was issued after the last inspection of the facility, which manufactures oral solids and ophthalmic dosage forms, conducted from March 21-29, 2023, the Mumbai-based drug maker said in a statement. The US Food and Drug Administration (FDA) issues an EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted scrutiny. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). According to the the USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. "This is a significant milestone as we build back our reputation of being best-in-class in quality and compliance. We look forward to ne

Lupin gets USFDA approval for generic version of Cyanocobalamin nasal spray

Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator for its generic version of Cyanocobalamin nasal spray. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Cyanocobalamin nasal spray of strength 500 mcg/spray (one spray per device), Lupin said in a statement. Cyanocobalamin nasal spray is used to maintain normal vitamin B12 blood levels in patients with pernicious anaemia. "This product will be manufactured at Lupin's Somerset facility in the US," the company added. Cyanocobalamin nasal spray had estimated annual sales of USD 69 million in the US, Lupin said, citing IQVIA MAT March 2023 data.

Lupin receives US regulator's approval for Cyanocobalamin nasal spray

The nasal spray manufactured by Lupin is a generic version of Nascobal nasal spray