Latest news with #Doxylamine
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
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Business Standard
05-05-2025
- Health
- Business Standard
Akums secures patent for dual-action nausea drug for pregnant women
Akums Drugs & Pharmaceuticals has received a patent for its extended-release combination formulation of Doxylamine and Pyridoxine, developed to manage nausea and vomiting in pregnancy (NVP). The formulation, using the company's proprietary 'tablet-in-tablet' technology, has been approved by the Drug Controller General of India (DCGI). NVP affects up to 80 per cent of pregnant women, with around 20 per cent experiencing symptoms throughout their pregnancy. The condition can impact nutrition, daily activity, and overall well-being. Akums' patented formulation combines immediate and sustained drug release in a single tablet, aimed at providing extended symptom relief and reducing dosing frequency. The outer layer of the tablet is designed for rapid onset, while the inner core provides a longer therapeutic effect. This dual-action mechanism is intended to improve dosing convenience and adherence. Commenting on the approval, Sanjeev Jain, Managing Director, Akums, said: 'This new formulation for managing nausea and vomiting during pregnancy ensures access to safe and effective care during a critical phase of life. With this, we are making life a little easier for expectant mothers and helping healthcare move closer to where it should be — accessible, reliable, and full of care.' The formulation has undergone a bioequivalence study. While subject numbers remain confidential as per regulatory norms, the data submitted was deemed sufficient for DCGI approval. Akums says the combination is positioned to address a treatment gap in pregnancy care by offering longer-lasting symptom control. Akums is a contract development and manufacturing organisation (CDMO) with 12 manufacturing units, four R&D centres, and more than 16,000 employees. It reports over 4,100 commercialised formulations and 220 products under development. The company's product pipeline spans multiple dosage forms and therapeutic categories. This development adds to Akums' existing portfolio of drug delivery innovations aimed at both domestic and export pharmaceutical markets.
