Page 31 - Pharma Sector

Bayer AG to hold off breakup plans despite investor pressure: Report

CEO Bill Anderson, at the helm since June last year, said in November he is weighing options to break apart the diversified company in a staggered fashion but would not rule out keeping all businesses

Lupin gets USFDA nod to market generic hyperuricemia treatment drug

Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic Febuxostat tablets, indicated for the chronic management of hyperuricemia in adult patients with gout. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Febuxostat tablets of strengths 40 mg and 80 mg, a generic equivalent of Uloric tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc, Lupin said in a regulatory filing. The product will be manufactured at the company's Pithampur facility in India, it added. The company said Febuxostat tablets of strengths 40 mg and 80 mg are indicated for the chronic management of hyperuricemia (elevated serum uric acid level) in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol; who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat tablets had estimated annual sales of U

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.

Price push: Domestic pharma market grew by 6.8% in 2023, shows data

With an 8 percent growth in the anti-infectives category, it is not surprising that GlaxoSmithKline Pharmaceuticals (GSK) Augmentin is the top selling brand in 2023, second year in a row

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

Cipla forges strategic partnership for global cell therapy advancements

The collaborative effort is aimed at developing and commercialising novel Cell therapy products for critical unmet medical needs in the US, Japan, and the EU

Implementing revised Schedule M rules uphill task for small pharma

Analysts also feel this move will help improve quality of Indian drugs

'Textiles, pharma powered industrial revolution in Gujarat in past 20 yrs'

A land of vibrant cultural heritage and traditions, Gujarat has undergone industrial evolution in the last two decades riding on the success of key sectors like textile, pharmaceuticals, diamond and fisheries, officials have said. Gujarat has become a global powerhouse in the textile, apparel and garment sectors by contributing over 60 per cent of India's denim fabric, spurred by the state's textile policy launched in 2012. Since then, the size of its textile exports has grown 2.3 times, they said. The growth in textile manufacturing has positioned Gujarat as a driving force in the country's economic growth, officials said ahead of the state's big-ticket Gujarat Vibrant Global Summit, which will be held next week. To take advantage of our future, we will have to invest in the local supply chain. This is the way to build a developed India, and this is the way to fulfil the dream of a developed India to fulfil the dream of a $5 trillion economy, Prime Minister Narendra Modi had said

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'

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

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

India launches a single-window portal for medical devices management

The Drugs Controller General of India said that the National Single Window System (NSWS) has been established as a 'genuine single-window system which acts as a one-stop shop for all approvals'

BDR Pharmaceuticals launches prostate cancer drug in oral solution form

BDR stated since BDENZA is in liquid form, they can't quantify how lower it is compared to its counterparts in the market as they are present in solid form (tablet/capsule)

Higher domestic demand, exports to put pharma SMEs in pink of health

This augurs well for small and medium enterprises (SMEs), which have a 35-40 per cent share in industry revenue

Govt expanding meeting requirement of medical professionals: Mandaviya

The government is following a holistic approach to health by not only upgrading and expanding infrastructure but also creating more institutions to meet the requirement of medical professionals, Union Health Minister Mansukh Mandaviya said on Friday. Addressing a gathering after laying the foundation stones for two critical care blocks and a BSL-3 laboratory in Vijayawada in Andhra Pradesh, he also stressed the need for collective efforts between the Centre and states to meet the healthcare needs of people. He assured the central government's support to states in their healthcare endeavours. Mandaviya also inaugurated seven integrated public health laboratories in different districts of Andhra Pradesh. The BSL laboratory, the seven integrated public health laboratories and the two critical care blocks, once operational, will play a pivotal role in providing quality medical services to the people of the state, he said. The event was attended by Andhra Pradesh Health Minister Vidadal

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

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.