Page 15 - Pharmaceutical Firms

USFDA finds new manufacturing lapses at pharma co Eli Lilly's plant: Report

Lilly said in a statement to Reuters that the inspection followed a company request to the FDA to make a change to its manufacture of migraine treatment Emgality

Sun Pharma to acquire remaining stake in Israeli firm Taro for Rs 2,892 cr

Merger would pave the way for Sun to consolidate its position in the US market, say analysts

Sun Pharma to buy remaining stake in Israeli unit Taro for about $348 mn

The Indian drugmaker, which currently owns about 78.5 per cent stake in Taro, had offered to buy its remaining stake for $38 per share in May

PLI payout for FY24 may lag behind govt's estimate of over Rs 11,000 crore

Ministries asked to ensure scheme is 'aggressively' monitored

Aster considering to pay 70-80% of $903 mn Gulf demerger money as dividends

The company said on Monday it plans to use the proceeds to pay shareholders between 110 rupees and 120 rupees per share as dividends

Lupin receives USFDA approval to market generic hypertension drug

Drug maker Lupin on Sunday said it has received approval from the US health regulator to market a generic hypertension drug in America. The company has received approval from the US Food and Drug Administration (USFDA) for Propranolol Hydrochloride extended-release capsules in multiple strengths, Lupin Ltd said in a regulatory filing. The company's product is the generic version of ANI Pharmaceuticals' Inderal LA extended-release capsules, it added. The product will be manufactured at the company's Pithampur-based manufacturing plant, the drug firm stated. Propranolol Hydrochloride extended-release capsules USP are indicated in the management of hypertension. They may be used alone or in combination with other antihypertensive agents, particularly a thiazide diuretic. As per IQVIA MAT November 2023 data, Propranolol Hydrochloride extended-release capsules had estimated annual sales of USD 71 million in the US.

Supriya Lifesciences targets Brazil, eyes Rs 200 crore sales in 2-3 years

This ambition follows the company's recent approval from Anvisa (Brazilian health regulatory agency), which has facilitated its entry into the Brazilian market

Uttar Pradesh to invest Rs 8,000 crore in 1,400-acre bulk drug park

The UP government has already signed 236 memorandum of understanding (MoU) worth Rs 11,000 crore with different companies and consortiums to set up their manufacturing plants

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.

Health Ministry revises pharma manufacturing rules under Schedule M

New GMP guidelines set to elevate drug quality and industry compliance

Government orders new drug-making standards after overseas deaths

The health ministry said in August that inspections of 162 drug factories since December 2022 found an 'absence of testing of incoming raw materials'

Indian-American medical biller held for stealing more than $1 million

A 61-year-old Indian-origin medical biller has been arrested for stealing more than USD 1 million from doctors who provided medical care to injured workers in New York, according to the Attorney General's Office here. Amrish Patel and his two companies -- Medlink Services and Medlink Partners -- were charged on Wednesday with 27 felony counts for the thefts they allegedly committed from January 2012 through January 2019, New York Attorney General Letitia James announced. Patel and the companies were charged with one count of insurance fraud in the first degree, one count of grand larceny in the first degree, one count of grand larceny in the second degree, one count of grand larceny in the third degree, one count of scheme to defraud in the first degree, 11 counts of falsifying business records in the first degree and 11 counts of workers' compensation fraud. He was released with electronic monitoring and a USD 100,000 bond, according to the New York Attorney General's Office. Pate

Leading domestic pharma Companies to see 9-11% revenue growth in FY24

Revenue of 25 leading domestic pharmaceutical companies is expected to grow 9-11 per cent in the current fiscal year, as per Icra. The projected revenue growth in 2023-24 will be primarily supported by 11-13 per cent expansion in the US market and 7-9 per cent growth in the domestic market, while revenues from the European market and emerging markets are expected to rise 11-13 per cent and 13-15 per cent, respectively, the rating agency said in a statement. "Icra expects the revenues of a sample set of 25 Indian pharmaceutical companies (which account for 60 per cent of the overall revenues of the Indian pharmaceutical industry) to expand by 9-11 per cent in FY24, post a year-on-year growth of 10 per cent in FY23," it noted. Icra said it foresees research and development expenses for its sample set of companies to stabilise at 6.5-7 per cent of their revenues as they will optimise spending, focusing more on complex molecules and specialty products against plain vanilla generics. Th

ICRA predicts 9-11% growth in FY24 fuelled by new launches, US rebound

ICRA anticipates expansion in revenues for its sample set of 25 companies, which represent approximately 60 per cent of the overall revenues of the Indian pharmaceutical industry

Glenmark cuts diabetes drug cost by 70% with first Indian biosimilar launch

Drug, marketed under the brand name Lirafit, is priced at approximately Rs 100 for a standard daily dose of 1.2 mg

Alembic Pharmaceuticals clinches eight USFDA approvals in Q3 FY24

The same day, Alembic Pharma's share price rose to 3.55 per cent, ending the day's trade at Rs 792 apiece on the BSE

Pharma lobby bats for drug approvals in India to align with global markets

Launching a new drug in India takes up to four years longer than in markets such as the United States and the European Union, said the pharma lobby

Aurobindo Pharma gets USFDA approval for generic antifungal injection

Aurobindo Pharma Ltd on Wednesday said its wholly-owned arm Eugia Pharma Specialities Ltd has received final approval from the US health regulator to manufacture and market generic Posaconazole injection used to prevent serious fungal infections. The approval by the US Food & Drug Administration (USFDA) is for Posaconazole injection of 300 mg/16.7 mL (18 mg/mL), single-dose vial, Aurobindo Pharma said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Noxafil Injection, 300 mg/16.7 mL (18 mg/mL), of Merck Sharp & Dohme LLC (Merck), it added. "The product is expected to be launched in December 2023," the company said. Posaconazole injection, 300 mg/16.7 mL (18 mg/mL), single-dose vial is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised due to certain conditions, it added. The approved ...

Zydus Lifesciences arm gets Rs 284.58 cr income tax demand notice

Zydus Lifesciences on Tuesday said its arm Zydus Healthcare Ltd has been served an income tax notice demand of Rs 284.58 crore for for the assessment year 2023-2024. Zydus Healthcare Ltd (ZHL), a wholly-owned subsidiary, has received an intimation under section 143(1) of the Income Tax Act, 1961 (IT Act), determining demand of Rs 284.58 crore, Zydus Lifesciences said in a regulatory filing. The intimation is for the assessment year 2023-2024 from the CPC, Income Tax Department, it added. The demand is determined due to "apparent mistakes while processing its return of income", it said. "The company strongly believes that once the rectification will be made, the entire demand will be deleted," Zydus Lifesciences said. ZHL has already disagreed with demand on the e-filing portal of the Income Tax Department. It is also going to file Rectification Application under section 154 of the IT Act, before the CPC as well as before the Jurisdictional Assessing Officer against the said ...

CRISIL analysis: Moderation in input prices to ease pressure on margins

Apart from creating a presence in generics, larger players are also developing specialty products, biosimilars, and complex generics, which will be key medium-term growth drivers for the industry