Page 29 - Pharma Sector

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

Emcure Pharmaceuticals refiles IPO papers to Sebi, trims issue size

The company had first submitted draft papers for its IPO in August 2021

Aurobindo Pharma gets 'Voluntary Action Indicated' classing from US FDA

The classification follows an inspection conducted by the FDA from September 13 to September 19, 2023

Up & down the job rollercoaster: Highs for aviation & pharma, lows for IT

The game flipped in the second half of 2022, and in 2023, it has decisively turned in the favour of employers - more talent is now chasing fewer active IT jobs

JB Pharma, Novartis ink Rs 1,089 cr deal for select ophthalmology brands

JB Chemicals & Pharmaceuticals Ltd (JB Pharma)on Tuesday said it has inked a trade mark licence agreement along with promotion and distribution pact with Novartis for select ophthalmology brands entailing a total sum of Rs 1,089 crore. The board of directors at its meeting held on December 19, 2023 approved the execution of a trade mark licence agreement with Novartis Innovative Therapies AG, which is perpetual in nature for the Indian market, for a portfolio of select ophthalmology brands which will be effective in January 2027, JB Pharma said in a regulatory filing. The board also approved the promotion and distribution agreement with Novartis Healthcare Pvt Ltd for the same portfolio of select ophthalmology brands for the Indian market for a period of three years starting December 2023, it added. On the financial details of the agreements, JB Pharma said it will pay USD 116 million (Rs 964 crore), excluding applicable taxes, stamp duty and working capital, for the trade marks ..

Zydus Noveltech dissolved for not generating 'meaningful revenue'

It had nil operating revenue and a net worth of Rs 10 crore as of March 31, 2023

Zydus gets USFDA's approval for antiviral drug used in HIV treatment

Zydus Lifesciences on Friday said it has received approval from the US health regulator to market a generic antiviral medication used in the treatment of HIV-1 infection. The company has received final approval from the US Food and Drug Administration (USFDA) for Darunavir Tablets, the company said in a statement. Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body. It is indicated for the treatment of HIV-1 infection in adult patients. It is also indicated for the treatment of HIV-1 infection in pediatric patients three years of age and older. It must be co-administered with Ritonavir and with other antiretroviral agents. Zydus said the product will be manufactured at the group's formulation manufacturing facility in SEZ, Ahmedabad, Gujarat. As per IQVIA MAT data, Darunavir tablets (75 mg, 150 mg, 600 mg, and 800 mg) had annual sales of USD 275 million in the US. Shares of the company were trading

Loss of patents: Indian pharma companies gain, shows PharmaTrac data

While MNCs posted a 5 per cent five-year compound annual growth rate (CAGR) in the chronic segment, Indian pharma companies have recorded a 9 per cent 5-year CAGR