Latest news with #Dapagliflozin
Fashion Value Chain
08-08-2025
- Business
- Fashion Value Chain
Akums Reports Q1 FY26 with 19% YoY Adj EBITDA Growth; Achieves 1,000 DCGI Approvals
Akums Drugs and Pharmaceuticals Ltd., India's largest contract development and manufacturing organization (CDMO), has announced its consolidated financial results for the quarter ended June 30, 2025. This quarter continued to display strong performance with healthy growth in Adj EBITDA and Adj PAT. In Q1 FY26, Akums reported total income of Rs. 1,051 crore, with healthy Adj EBITDA of Rs. 156 crore reflecting a robust 19.1% year-on-year (YoY) growth. The margins improved to 14.8% from 12.7% last year a 208 bps improvement. During this quarter, the company achieved a key milestone of reaching 1,000 Drug Controller General of India (DCGI) approvals, with 27 fresh approvals in this quarter. The DCGI approvals assist the company in enhancing its product mix, building a differentiated and research-driven portfolio. Additionally, the company also received a patent for its extended-release combination formulation of Doxylamine and Pyridoxine developed using the company's tablet in tablet technology. As part of Akums' strategic vision to establish itself as a leading global CDMO, the company received its first EU dossier approval for Rivaroxaban. It also filed its first dossier of Dapagliflozin combination in Switzerland. Both of these new products hold significant market potential. The commercialization of the EU contract also continues to be on track and the company will commence commercial supplies from April 2027. Akums received 100 mn Euros as part consideration for the EU contract in Q1 this year, consequently the company is at a cash surplus of Rs. 1,518 cr. The strong liquidity position provides a robust foundation for Akums to strategically scale up its business operations through both organic growth initiatives and inorganic opportunities. Segmental Performance Overview Akums' flagship business, CDMO, contributed ~79% to the group turnover with an EBITDA of 14.7% in Q1 FY 26. The company's domestic branded formulation business segment reported ~3% YoY growth while international branded formulation business grew by ~2% YoY. Trade generics and API segment continue to be in operational loss this quarter, though, through the management efforts, the losses are gradually reducing. Commenting on the results, Mr. Sanjeev Jain, Managing Director, said, 'This date marks just over one year since we got listed. We continue to work towards strengthening the organization with a focus on long term growth. Our commitment to becoming a global CDMO player remains steadfast. The recent filings along with the planned global approvals of other facilities are setting up us in that endeavor.' Mr. Sandeep Jain, Managing Director, added, 'We continue to deliver strong performance despite the industry headwinds of decreasing API prices and muted volume growth. With a sustained focus on R&D, we have been able to deliver robust growth. Achieving 1,000 DCGI approvals is a key milestone that stands out Akums from its peers, allowing Akums to offer margin accretive differentiated offerings. We remain focused on strengthening our CDMO leadership, scaling high-value capabilities, and driving operational excellence. Backed by a strong pipeline and prudent capital allocation, we are well-positioned to deliver sustainable and profitable growth in the years ahead.' Extract of Consolidated financial results Particulars (Rs Cr) Q1 FY 26 Q4 FY 25 Q1 FY 25 Revenue 1,024 1,056 1,019 Other income 27 18 7 Total income 1,051 1,073 1,026 Cost of goods sold 582 639 596 Employee Cost 176 184 176 Other Expenses 137 139 123 Adj EBITDA 156 111 131 Adj EBITDA Margin 14.8% 10.4% 12.7% Adj PAT 65 44 57 Adj PAT Margin 6.2% 4.1% 5.6% Definitions Adjusted EBITDA has been calculated as the sum of profit/ (loss) for the quarter, tax expenses, finance costs, depreciation and amortization expense, fair value changes to financial instruments, and exceptional items. Adjusted PAT is calculated as the profit for the quarter plus fair value changes to financial instruments less tax deferred tax created on brought forward losses. CDMO: Contract Development and Manufacturing Operations API: Active Pharmaceutical Ingredients
Medscape
05-08-2025
- Health
- Medscape
Dapagliflozin Delivers Post-MI, Regardless of BMI and A1c
TOPLINE: Dapagliflozin, an SGLT2 inhibitor, reduced the incidence of new-onset type 2 diabetes (T2D) following myocardial infarction (MI), regardless of baseline BMI or A1c levels, with a substantial reduction in heart failure symptoms seen in those with prediabetes and obesity. METHODOLOGY: Researchers performed a subanalysis of the DAPA-MI trial to assess whether cardiometabolic benefits of dapagliflozin after MI varied by baseline glycaemic status or BMI. They included patients who experienced acute MI within the last 7-10 days with impaired left ventricular systolic function and had no prior history of T2D or chronic heart failure. Patients were randomly assigned to receive either dapagliflozin (n = 1725; mean age, 62.9 years; 19% women) or placebo (n = 1700; mean age, 62.8 years; 20% women). In this subanalysis, patients were categorised as those having normal glycaemic levels (A1c levels < 5.7%) or having prediabetes (A1c levels, 5.7% to < 6.5%); BMI categories were < 25, 25 to < 30, and ≥ 30. Key outcomes included new-onset T2D and the occurrence of heart failure symptoms classified on the basis of the New York Heart Association (NYHA) class, assessed over a median follow-up duration of 11.6 months. TAKEAWAY: Patients who received dapagliflozin had a lower risk for new-onset T2D, irrespective of their baseline glycaemic status or BMI, than those who received placebo. Patients on dapagliflozin vs placebo showed a reduction in NYHA class III-IV symptoms, with a more pronounced effect seen in those with prediabetes than in those with normal A1c levels (P interaction = .009). Patients with both prediabetes and BMI ≥ 30 showed a 71% reduction in the occurrence of NYHA class III-IV symptoms with dapagliflozin (P = .005), corresponding to a 1-year absolute risk reduction of 10%. Dapagliflozin was similarly effective in achieving 5% or more weight loss across all A1c levels and BMI categories; rates of cardiovascular events were comparable between dapagliflozin and placebo groups. IN PRACTICE: "The findings of the present subanalyses support having a low threshold for commencing SGLT2 inhibition following acute MI in those with evidence of dysglycemia and/or obesity," the researchers wrote. SOURCE: This study was led by Robert F. Storey, MD, DM, University of Sheffield, Sheffield, England. It was published online on July 29, 2025, in the Journal of the American Heart Association. LIMITATIONS: The definition of the subgroups in a post hoc manner may have introduced bias. All assessments were performed only during active treatment; thus, glycometabolic effects after stopping medication remained uncertain. The follow-up period was relatively short, event rates were low, and CIs for hazard ratios were wide. DISCLOSURES: The DAPA-MI trial received funding from AstraZeneca. Several authors reported receiving research grants, personal fees, and consulting honoraria and having other financial ties with various institutes and pharmaceutical and healthcare companies including AstraZeneca. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
&w=3840&q=100)
Business Standard
23-06-2025
- Business
- Business Standard
Kashmik Formulation targets ₹100 crore revenue in FY26, eyes IPO
With a growing emphasis on affordable medicines and export-led growth, Ahmedabad-based Kashmik Formulation is targeting revenue of Rs 100 crore for FY26 — more than double its FY25 topline of Rs 40 crore. The company is planning to boost production capacity and invest in automation as it eyes new markets and future growth. Kashmik Formulation is also considering an initial public offering (IPO) within the next two to three years to scale its market presence and support future growth. While aiming to be a major player, it does not expect to become a top 20 or top 10 Indian contract manufacturer in the immediate term, considering it part of a longer-term plan. Founded in 2017, the company operates at full capacity with a daily output of 10 million tablets. Kashmik is now investing Rs 20 crore to ramp up capacity by 50 per cent to 15 million tablets per day. The company currently produces around 250 million units a month and is expanding its ground and first-floor production facilities to meet the rising demand. 'Our current clients include Cipla and Dr. Lal Pathlabs. At this point, our contract manufacturing capacity is fully utilised, but once the new capacity comes online, we will look to onboard more clients,' said Nilesh Patel, managing director. Branded generics account for nearly 70 per cent of Kashmik's revenue, with contract manufacturing contributing 20–30 per cent. The company is also stepping up its export focus, aiming to increase the share of exports from the current 20 per cent to 50 per cent over the next few years. Kashmik is in the process of registering its products in semi-regulated markets such as Africa, Myanmar, and Latin America. 'We're not targeting regulated markets yet, but we're actively working to expand in semi-regulated geographies. Registration is underway, and that will be a key driver for our export ambitions,' said Patel. To improve operational efficiency, Kashmik is also investing Rs 4–5 crore in packaging automation and AI-driven solutions. While the company is not yet investing heavily in research collaborations, it has plans to set up a new research and development centre in Jammu. A foray into injectables is also on the cards, with a new facility planned within the next 3–5 years. On the pricing front, Kashmik has launched Dapagliflozin, an anti-diabetic drug under its DAPNEC brand, which the company claims is priced approximately 400 per cent lower than competing brands. 'It's a highly competitive space, but we're targeting volume growth through affordability,' said Patel. Like many Indian pharma companies, Kashmik faces challenges in active pharmaceutical ingredient (API) sourcing, especially due to heavy dependence on China. 'Cost remains a major barrier to diversifying away from Chinese APIs. Any disruption in supply from China could hit production significantly,' Patel added. Despite headwinds, the company is optimistic about its growth trajectory.
New Indian Express
06-06-2025
- New Indian Express
Illegally stocked drugs worth Rs 5.21 lakh seized
HYDERABAD: The Drugs Control Administration (DCA) raided the residence of a habitual offender in Moosarambagh, Malakpet, and seized spurious drugs worth Rs 5.21 lakh. The accused, Puvvada Lakshmana, is a repeat offender previously involved in multiple spurious drug cases across the state. He had illegally stocked a large quantity of drugs at his home. During the raid, four varieties of suspected spurious medicines were seized, including antidiabetics, antihypertensives, and abortion kits. Acting on a tip-off, DCA officials raided the premises on Wednesday and recovered drugs such as Tazloc-CT 6.25 (Telmisartan and Chlorthalidone tablets), Dapacose-10 (Dapagliflozin tablets 10 mg), Dapacose-5 (Dapagliflozin tablets 5 mg), and Clear-Kit (combipack of Mifepristone and Misoprostol tablets). Samples have been sent for analysis. Officials confirmed that further investigation is underway, and legal action will be taken against all those involved.
