Pharmaceutical Firms

Big pharma: Here's why India's drug industry needs a major overhaul

The latest drug recalls just add to a long line of scandals that have tainted the pharma sector of India

Nifty Pharma index hits 2-year low; Cipla, Divis, Laurus Labs at 52-wk lows

Analysts said the pace of US FDA inspections has again picked-up in the last few months post Covid, and they have seen increased incidents with 483 observations and adverse outcomes

Natco launches additional strengths of generic version of Revlimid in US

Natco Pharma Ltd on Friday said it has launched additional strengths for its generic lenalidomide capsules used in the treatment of multiple myeloma, in the US. The company has launched 2.5 mg, and 20 mg strengths of the generic version of Revlimid (lenalidomide capsules) through its marketing partner Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd, Natco Pharma said in a regulatory filing. "With this launch the companies (have) made available all the strengths of lenalidomide in the US market," it added. Lenalidomide capsules are a prescription medicine used in adults for the treatment of multiple myeloma, the filing said.

Natco Pharma's Q3 consolidated net profit dips 22% yoy at Rs 62 cr

Natco Pharma on Thursday said its consolidated net profit declined by 22 per cent to Rs 62 crore for the third quarter ended December 31, 2022. The Hyderabad-based drug firm had reported a net profit of Rs 80 crore in the October-December quarter of last fiscal. Total income of the company stood at Rs 513 crore in the period under review as compared with Rs 591 crore in the year-ago period that had a one-time licensing revenue. The company's board, which met on Thursday, approved an interim dividend of Rs 1.25 per share for the quarter ended December 31, 2022. Shares of the company ended 0.38 per cent down at Rs 529.10 apiece on the BSE.

Piramal Pharma reports consolidated net loss of Rs 90 crore in Q3

Piramal Pharma on Thursday reported a net loss of Rs 90 crore on a consolidated basis for the third quarter ended December 31, 2022. The Mumbai-based company had reported a net profit of Rs 163 crore in the October-December quarter of last fiscal. Revenue from operations stood at Rs 1,716 crore for the third quarter, while the same was at Rs 1,539 crore in the year-ago period. The company said the third quarter results were not comparable to the same period last year as the NCLT in August 12, 2022 approved the composite scheme of demerger of the pharma business from Piramal Enterprises Ltd (PEL) into Piramal Pharma Ltd. The NCLT also approved amalgamation of Piramal Pharma's wholly-owned subsidiaries Hemmo Pharmaceuticals and Convergence Chemical into itself with an appointed date of April 1, 2022. Accordingly, the financial statements of Piramal Pharma have been prepared giving effect to the scheme from April 1, 2022. "Based on our recent increase in customer engagements and ...

Lupin recalls 5,720 skin treatment tubes in US due to manufacturing issue

Drug maker Lupin is recalling 5,720 tubes of a cream used in the treatment of various skin conditions, such as dermatitis, eczema and psoriasis, from the US market due to a manufacturing issue, according to the US Food and Drug Administration. As per the latest Enforcement Report by the US health regulator, Lupin Pharmaceuticals Inc, a US-based arm of the Mumbai-based drug maker, is recalling Clobetasol propionate Cream, a steroid to reduce inflammation, redness and itchiness of the skin and prevent further irritation of the skin. The affected lot has been manufactured at the company's Pithampur plant in Madhya Pradesh and marketed in the US market by Baltimore-based Lupin Pharmaceuticals Inc. The USFDA noted that the company is recalling the affected lot due to "Subpotent Drug: Low assay result observed during long-term stability testing". The company initiated the Class III nationwide (US) recall of the affected lot on January 23 this year. As per the USFDA, a class III recall i

Chennai-based pharma firm recalls eye drops from US after 55 adverse cases

A Chennai-based company has recalled its eye drops from the US market after a US govt agency has informed the company that several adverse events had taken place

Business initiative that has a heart: Lupin eyes Lyfe beyond the pill

Its digital health initiative for cardiac patients is part of its strategy to diversify into healthcare services

US industry seeks R&D policy for India's pharma sector ahead of Budget 2023

Ahead of the Union Budget 2023-24, the US pharma industry has said that India should come out with a research and development policy for its pharmaceutical sector. Union Finance Minister Nirmala Sitharaman is scheduled to table the Union Budget for the financial year 2023-24 before parliament on February 1. It is time that the government of India comes out with a research and development policy for the pharmaceutical sector, Karun Rishi, president of USA-India Chamber of Commerce (USAIC) told PTI. Based out of Boston, the USAIC for the last 16 years has been organising the India-US health care summit which is attended by the who's who of the pharma sector from both India and the United States. In the BioPharma sector, the budget should aim to move up the value chain driven by research and development. Right policy push can provide India the fuel to become the R&D hub of the world, Rishi said in response to a question. For national security and stabilising the global supply chain,

Macleods Pharma recalls 10,000 bottles of anti-bacterial medication in US

Macleods Pharmaceuticals is recalling around 10,000 bottles of generic antibiotic medication in the US market due to a labelling error, according to the US health regulator. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Macleods Pharma Inc, a US-based unit of the company, is recalling 10,052 bottles of Levofloxacin tablets, which are used to treat different types of bacterial infections. The company is recalling the affected lot due to"mismatching of the embossing on the tablets with the embossing mentioned in the package insert in the distributed bottles." Macleods manufactured the affected lot in its Baddi-based manufacturing plant in Himachal Pradesh. The company initiated the Class III recall in the US and Puerto Rico on January 5. As per the USFDA, a Class III recall is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. The US generic drug market was estimate

Budget wishlist: Pharma, healthcare industries seek simplified regulations

Fortis Healthcare MD & CEO Ashutosh Raghuvanshi said increased policy support is required to encourage, facilitate medical value travel to India

Lupin gets USFDA tentative nod for generic drugs to treat HIV infection

Pharmaceutical firm Lupin on Monday said it has received tentative approval from the US health regulator to market its generic version of Dolutegravir and Rilpivirine tablets used in treatment of HIV infection. The tentative approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, Lupin said in a regulatory filing. The Dolutegravir and Rilpivirine tablets, 50 mg/25 mg had estimated annual sales of USD 666 million in the US, the company said citing IQVIA MAT September 2022 data.

Drug firm Gland Pharma to fully acquire Europe-based Cenexi Group

Drug firm Gland Pharma on Friday said it has inked a pact with FPCI Sino French Midcap Fund to acquire 100 per cent stake in Europe-based Cenexi Group. Gland Pharma International PTE, a Singapore-based wholly owned subsidiary of the company, has entered into a share purchase agreement with FPCI Sino French Midcap Fund to fully acquire stake in Cenexi pursuant to the terms of the put option agreement inked in November last year. On November 29, 2022, the Hyderabad-based drug contract development and manufacturing company (CDMO) had entered into a put option agreement to acquire Cenexi Group for up to EUR 120 million (around Rs 1,015 crore), marking its foray into the international markets. Under the put option, an entity gets the right not obligation to sell a specified amount or stake at a predetermined price. Founded in 2004, Cenexi, along with its subsidiaries, is engaged primarily in the business of contract development and manufacturing organisation (CDMO) of pharmaceutical ...

Granules forges strategic partnership with Greenko ZeroC for Kakinada plant

Under the collaboration, Greenko ZeroC will be supplying carbon free energy and enable green hydrogen along with its various chemical derivatives

Govt inquires pharma firms' stock, adequacy of Covid management drugs

Union Health Minister Mansukh Mandaviya on Thursday asked pharma companies to ensure adequate stocks and availability of all drugs, including those for Covid management, in the supply chain up to the retail level amid rise in coronavirus cases in some countries. He reviewed the status, adequacy of COVID-19 management drugs and production capacities with representatives of pharma companies through a virtual conference here so that India is equipped to effectively handle any situation. This review meeting was taken in view of the spike in COVID-19 cases in some countries including China, an official statement said. Through a presentation, the minister was briefed regarding the evolving global scenario. Mandaviya appreciated the pharma companies for their invaluable contribution during the pandemic in the country, the statement said. "India's pharmaceutical industry is robust, resilient and responsive. It is due to their strength that we could not only meet our down demand during the

WHO stands by action of issuing alert against Maiden Pharma cough syrup

Asserts that testing done in labs in Ghana and Switzerland confirmed excess levels of contaminated syrups that are "dangerous and should not be in any medicine, ever"

Maiden Pharma's cough syrups are safe, WHO jumped the gun: DCGI

'Irreparable damage' to Indian pharma's global image, drug regulator writes to WHO

Fosun's sale of Gland Pharma to become India's biggest pharma deal: Report

With the acquisition, Gland pharma may also get access to global companies like AstraZeneca, Sanofi, Mylan, and Organon

Drug regulators, pharma firms step up action on fake and substandard drugs

Detection of spurious and substandard drugs was up by 47% from 2020 to 2021, according to an ASPA Report

Pharma logs 17% growth in Nov; anti-infective therapy drives market demand

Key antibiotic brands like Augmentin (GSK) and Clavam (Alkem) clocked 25 per cent and 29 percent growth, respectively, in November, the data showed