Page 2 - Pharma Companies

Cough syrup deaths: Probe into Coldrif manufacturer exposes TNFDA lapses

The investigation against the Kanchipuram-based manufacturer of Coldrif cough syrup, linked to the deaths of children in Madhya Pradesh, has brought to light lapses by the Tamil Nadu Food and Drug Administration in enforcing basic regulatory norms, CDSCO sources said. Licensed in 2011 by the Tamil Nadu Food and Drug Administration (TNFDA), Sresan Pharma continued operations unchecked for over a decade despite its dismal infrastructure and multiple violations of national drug safety rules, they said. A recent inspection by the Central Drugs Standard Control Organisation (CDSCO) exposed the unit's appalling conditions and total non-compliance with Good Manufacturing Practices (GMP), the sources said. "The CDSCO has not been involved in any of the audits at Sresan Pharma. Since the CDSCO was not involved and the state FDA did not inform the CDSCO about this company in any way, this company was not part of any of the CDSCO databases," a source said. TNFDA officials could not be reached

AstraZeneca to strike landmark drug price deal with Trump administration

The deal is expected to be announced at the White House on Friday, said the people, who spoke on condition of anonymity because the plans are not yet public

Lupin gets USFDA nod for generic cancer drug Lenalidomide capsules

Lupin has received USFDA approval for generic Lenalidomide capsules in six strengths, adding to competition in the US oncology market for Bristol-Myers Squibb's Revlimid

Mankind joins hands with OpenAI to institutionalise AI in operations

"GPT-powered dashboards will be used to provide real-time, data-driven insights across R&D, supply chain and commercial operations," a company executive told Business Standard

India's bulk drug makers start preparing for Ozempic patent expiry

From local giants Dr Reddy's Laboratories Ltd. to suppliers like Macleods Pharmaceuticals Ltd., Indian firms are preparing to make bulk drugs

NPPA asks pharma, medtech firms to cut prices after GST rate reduction

NPPA directs pharma and medical device makers to revise MRPs after GST cut to 5 per cent, while making relabelling of old stock voluntary subject to compliance

Biocon inaugurates first manufacturing facility in New Jersey's Cranbury

Biocon Ltd on Thursday said it has inaugurated its first manufacturing facility in the US, located in Cranbury, New Jersey. The company's wholly-owned subsidiary, Biocon Generics Inc. (BGI), operates the plant. Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc in 2023 and has since invested over USD 30 million to establish a plant with an annual production capacity of 2 billion tablets. A few products have already been commercialised from the site, with several more in the pipeline, the Bengaluru-based firm said in a statement. This investment helps Biocon diversify its manufacturing base, strengthen its supply chain and accelerate the expansion of its global footprint, it added. "Biocon's first USFDA-approved formulations facility in New Jersey marks a new chapter in our journey of global expansion," Kiran Mazumdar-Shaw, Chairperson of Biocon Group, said. The facility reflects the company's long-term commitment to deeper engagement with healthcare provide

Glenmark starts multi-nation Phase 3 clinical trials for lung cancer drug

Glenmark Pharmaceuticals on Friday said it has initiated a multi-country Phase 3 clinical trial for Envafolimab, a novel drug for third-stage non-small cell lung cancer. The company said it has received approval from the Drugs Controller General of India to begin patient enrolment and dosing in the country. In parallel, the drug firm has submitted a clinical trial application in Russia and is preparing to open additional clinical trial sites in Brazil and Mexico, Glenmark said in a statement. The randomised, multi-centre, Phase 3 trial will assess the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with third-stage non-small cell lung cancer (NSCLC). Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC comprising around 80-85 per cent of cases. "By advancing this trial across multiple geographies, we are reinforcing our commitment to transforming the standard of care in Stage III NSCLC and addressing one of the grea

Ethical marketing code: Cost of compliance may rise for drug, device firms

UCPMPD 2024 boosts transparency and ethics, but smaller firms may struggle with higher costs and reporting demands

Akums Drugs announces JV to set up manufacturing facility in Zambia

Akums will hold 51% in its joint venture with the Zambian government to set up a pharma manufacturing facility, marking its first overseas plant and Africa expansion

Aurobindo Pharma expects China plant to break even at Ebitda level in FY26

Aurobindo Pharma expects its China facility to break even in the third quarter of the current financial year, according to its CFO Santhanam Subramanian. The Hyderabad-based drug maker commenced operations at the facility in the last week of November 2024 and is now ramping up production. "This facility with an initial capacity of 2 billion units plus is ramping up as expected and will begin contributing to revenue in the coming quarters and is expected to break even at the EBITDA (earnings before interest, taxes, depreciation, and amortisation) level by Q3 FY26," Subramanian said in an analyst call. He noted that around USD 145 million has been invested in the facility, which commenced production and invoicing in Q4 FY25 and Q1 FY26, respectively. Elaborating on other investments, Subramanian said the company has invested about USD 70 million in two US facilities, with production expected to start in the current fiscal year. Elaborating further, he noted that the company plans to

Ozempic maker's plight shows why managing markets matter for pharma giants

Novo's shares plunged amid rising competition, missed expectations, and governance issues, exposing the risks of neglecting market sentiment in high-growth pharma bets

Trump demands pharma companies slash US prices in blow to industry

In the letters, sent to Eli Lilly & Co., Novo Nordisk A/S, Pfizer Inc. and others, Trump insisted companies immediately lower what they charge Medicaid for existing drugs

Sun Pharma Q1 net profit falls 20% Y-o-Y; revenue rises 9%

Litigation, drug discontinuation weigh on earnings; US market remains sluggish even as India sales and Leqselvi launch boost specialty push

Pharma Inc hopes for fair deal as Donald Trump announces 25% tariffs

Trump on Wednesday called India's tariffs on US exports among the highest in the world, with the most strenuous non-monetary trade barriers of any country, in a post on Truth Social

JB Pharma Q1 profit up 14%, revenue up 9% on domestic segment gains

Domestic, CDMO and API businesses drive growth for JB Pharma in Q1FY26 as Razel crosses Rs 100 crore and ophthalmology portfolio sees 19 per cent expansion

Dr Reddy Laboratories Q1 profit up 2%, posts best ever quarterly revenue

Dr Reddy's reported Rs 1,417 crore net profit in Q1 FY26, driven by new launches and price hikes; firm outlines global semaglutide strategy and GLP-1 product pipeline

Sun Pharma launches Leqselvi in US after patent settlement with Incyte Corp

Sun Pharma will pay Incyte an upfront fee and royalties to market Leqselvi in the US for alopecia areata until patent expiry in FY26 following a litigation settlement

GMP, NSQ compliance: MSME pharmaceutical companies seek financial aid

Pharma MSMEs seek Rs 50 crore handholding and extension for GMP compliance under revised Schedule M, citing challenges in adhering to regulatory and quality standards

HC-ordered expert panel for weight loss drug may be set up by mid-July

A Delhi HC directive to examine unregulated use of weight loss drugs may lead to a CDSCO expert panel by mid-July, possibly led by DCGI with pharma and govt representation