Lupin

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.

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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.

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

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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.

Lupin bags gets approval from USFDA to market generic product in America

Drug maker Lupin on Thursday said it has received approval from the US health regulator to market a generic medication, used before a surgery to decrease the volume of secretions from mouth, lungs and stomach, in the American market. The company has received approval from the US Food and Drug Administration (USFDA) for Glycopyrrolate Injection, a generic equivalent of Hikma Pharmaceuticals' Robinul Injection, the Mumbai-based drug maker said in a statement. The product marks the first approval from the company's new injectable facility in Nagpur, it added. "We are committed to building a strong injectable business as part of our growth strategy," Lupin CEO Vinita Gupta said. With the approval of the product from the Nagpur facility, the company can now fast-track its injectable portfolio rollout and build on R&D capabilities in complex products, she added. The approval for Glycopyrrolate clears the path for more internally manufactured injectable products, Gupta stated. As per ..

Lupin recalls 5,720 skin treatment tubes in US due to manufacturing issue

Drug maker Lupin is recalling 5,720 tubes of a cream used in the treatment of various skin conditions, such as dermatitis, eczema and psoriasis, from 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 maker, is recalling Clobetasol propionate Cream, a steroid to reduce inflammation, redness and itchiness of the skin and prevent further irritation of the skin. The affected lot has been manufactured at the company's Pithampur plant in Madhya Pradesh and marketed in the US market by Baltimore-based Lupin Pharmaceuticals Inc. The USFDA noted that the company is recalling the affected lot due to "Subpotent Drug: Low assay result observed during long-term stability testing". The company initiated the Class III nationwide (US) recall of the affected lot on January 23 this year. As per the USFDA, a class III recall i

Business initiative that has a heart: Lupin eyes Lyfe beyond the pill

Its digital health initiative for cardiac patients is part of its strategy to diversify into healthcare services

Lupin Digital launches Lyfe, a 24x7 monitoring ecosystem for heart patients

Company aims to onboard one million patients the platform, which aims to help them improve heart health through doctor-connected online and offline modules

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.