Page 28 - Pharma Sector

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.

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 ...

Trade generics growth to dent value expansion of domestic drug market

Jan Aushadhi and trade generics together constitute 20-22% of pharma market volumes

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

Aurobindo Pharma's new injectable facility get 10 observations from US FDA

"The observations are procedural and will be responded to within the stipulated time," the company stated in a regulatory filing

Lupin expands global portfolio with acquisition of assets from Sanofi

The deal involves the acquisition of a portfolio of accretive established products in Europe and Canada