Page 32 - Pharma Sector

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

Health ministry body IPC issues alert against reactions of mefenamic acid

The Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert advising healthcare professionals and patients to monitor adverse reactions of painkiller Meftal, commonly used for menstrual cramps and rheumatoid arthritis. The mefenamic acid painkiller is prescribed in the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhoea, mild to moderate pain, inflammation, fever and dental pain. The commission, in its alert, stated that a preliminary analysis of adverse drug reactions from the Pharmacovigilance Programme of India (PvPI) database revealed drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome. "Healthcare professionals, patients/consumers are advised to closely monitor the possibility of the above adverse drug reaction (ADR) associated with the use of the suspected drug," according to the alert, issued on November 30. If such reaction is encountered, the alert advised, people should report the matter to the national coordination centre of

Mefenamic acid can have adverse reactions; govt issues drug safety alert

The Indian Pharmacopoeia Commission (IPC) states that painkiller Meftal can cause adverse reactions, including drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome

Telangana CM orders stringent action against drug supply, abuse in state

The CM held a review meeting on the narcotic drug menace at the Dr BR Ambedkar Telangana Secretariat on Monday

Sun Pharma revises upwards price to fully acquire Taro to $43 per share

Sun Pharmaceutical Industries on Tuesday said it has revised upwards the price at which it proposed to fully acquire Israel-based Taro Pharmaceutical Industries to USD 43 per share in cash. In May this year, the company announced a non-binding indication of interest to acquire all of the outstanding ordinary shares of Taro for a purchase price of USD 38 per ordinary share in cash through a reverse triangular merger. Subsequently, the company was engaged in multiple rounds of price negotiations with a special committee of the Board of Directors of Taro regarding the proposal. Such negotiations resulted in the company communicating to the special committee updated terms pursuant to which the company has proposed to acquire all of the outstanding shares of Taro's ordinary shares for a purchase price of USD 43 per share in cash, Sun Pharmaceutical Industries said in a regulatory filing. Further, the company said that on December 10, the special committee confirmed that it agreed in ...

Reports claiming non-procurement of contraceptives misleading: Govt

The Union Health Ministry Tuesday termed "misleading" reports claiming that India's family planning programme is likely to get severely affected due to the country's central procurement agency's failure in procuring contraceptives. "Such reports are ill-informed and provides misleading information," the ministry said in a statement. The Central Medical Services Society (CMSS), an autonomous body and a Central Procurement Agency under Union Ministry of Health, procures condoms for National Family Planning Programme and National AIDS Control Programme. "The CMSS procured 5.88 crores pieces of condoms for Family Planning Programme in May, 2023 and the present stock position of condoms is sufficient to meet the requirement of the Family Planning Programme," the ministry said. Currently, National Aids Control Organization (NACO) is receiving supplies of 75 per cent free condoms from M/s HLL Lifecare Ltd. and is preparing to place remaining 25 per cent quantities for 2023-24 with CMSS on

War-wracked Myanmar now world's top opium producer, says UN agency

Myanmar, already wracked by a brutal civil war, has regained the unenviable title of the world's biggest opium producer, according to a UN agency report released on Tuesday. The Southeast Asian country's opium output has topped that of Afghanistan, where the ruling Taliban imposed a ban on its production, the United Nations Office on Drugs and Crime said in its Southeast Asia Opium Survey 2023." The Taliban's ban has led to a 95 per cent drop in the cultivation of opium poppies, UNODC said last month. Opium, the base from which morphine and heroin are produced, is harvested from poppy flowers. From 2022 to 2023, Myanmar saw the estimated amount of land used to grow the illicit crop increase 18 per cent to 47,100 hectares (116,400 acres), the new UNODC report said. Although the area under cultivation has not returned to historic peaks of nearly 58,000 ha (143,300 acres) cultivated in 2013, after three consecutive years of increases, poppy cultivation in Myanmar is expanding and ...

China's children battling pneumonia shows dangers of drug resistance

An outbreak of walking pneumonia, normally a mild infection, struck millions of children in the second half of 2023, creating Covid flashbacks and raising fears about another novel pathogen