Page 10 - Lupin

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

Stocks to Watch on Aug 4: SBI, Zomato, Paytm, Airtel, M&M, Vedanta, GAIL

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

Lupin gets $25 mn from AbbVie for meeting key product development milestone

Drug firm Lupin on Thursday said it has received USD 25 million (around Rs 205 crore) from AbbVie Inc for meeting a key development milestone for a product to treat hematological cancers. The company has achieved a key milestone for its novel MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program that is partnered with AbbVie Inc towards treatment across a range of hematological cancers, the Mumbai-based drug maker said in a statement. As part of the agreement, Lupin has received USD 25 million from AbbVie for initiation of Phase 1 clinical studies successfully, it added. The drug maker had earlier received USD 30 million from AbbVie for achievement of other milestones in the programme. "This achievement is further validation of our ability to successfully develop novel treatments for unmet needs. We look forward to continued successful development of this important treatment for patients with difficult-to-treat cancers," Lupin Managing Directo

Lupin likely to demerge its active pharmaceutical ingredients business

As such the API business contributes around 7 percent to Lupin's overall turnover

Stocks to Watch: Lupin, Vi, Tech M, Bharti Airtel, Aditya Birla Capital

Stocks to Watch on June 27, 2023: Lupin: As per reports, Lupin is considering a restructuring move to unlock value by demerging its API (active pharmaceutical ingredients) business

Spiriva approval gives earnings visibility to Lupin; valuations expensive

Lupin's shares declined 4.5 per cent in Thursday's intra-day trade

Lupin hits 52-wk high; rallies 7% on US FDA nod for key respiratory drug

Lupin has received US FDA nod for Tiotropium Bromide Inhalation Powder in the strength of 18 mcg per capsule. The drug is a generic equivalent of Spiriva HandiHaler, used for pulmonary patients

Lupin signs MoU with Maharashtra govt to combat rising prevalence of CVD

Collaboration to enhance healthcare services, ensure timely diagnosis, and improve accessibility of healthcare services

Pharma major Lupin gets establishment inspection report from USFDA

Lupin Limited received an inspection classification of "No Action Indicated" (NAI) after the inspection, which was conducted between March 6 to March 10

Pharma major Lupin receives approval from US FDA for diazepam rectal gel

Diazepam Rectal Gel had estimated annual sales of $34 million in the US

Lupin extends gain, hits 52-wk high post Q4 results; surges 20% in 1 month

Analysts believe the stock is factoring margin recovery and certain niche launches in the US.

Sensex climbs 179 pts in fag-end, Nifty tops 18,300; auto, bank stocks lead

CLOSING BELL: The fag-end rally was powered by IndusInd Bank, Bajaj Finance, Tata Motors, Reliance Industries, HDFC Bank, Maruti Suzuki, and Bajaj Finserv