As we conclude another remarkable year at Macsen Labs, we review a period characterized by expansion and new initiatives. Below is a retrospective analysis of the significant advancements and accomplishments that influenced our organization throughout the financial year 2023-24.
Innovative Breakthroughs and Product Launches –
New APIs Launched:
This year, Macsen continued to pioneer in the fields of pharmaceuticals and chemistry. We successfully launched several new products, including-
- Deferiprone: Used as an Iron Chelator in Thalassemia
- Nicorandil: Used as a vasodilator to treat Angina
- Viloxazine Hydrochloride: Used to treat Attention-deficit/hyperactivity disorder (ADHD)
These products have been recognized as game-changers in their respective applications. Our commitment to using cutting-edge technology has not only advanced our product offerings but also reinforced our position as industry leaders.
Additional products undertaken for research and development in the pipeline are Levomefolate Calcium, Ciclopirox Olamine, and Amylmetacresol.
Positive progress in development of high-quality and high-purity Prussian White for sodium-ion batteries:
India’s efforts to promote a sustainable economy have led to substantial expansion in the Energy Storage Systems (ESS) sector. To contribute to the renewable energy space, we started the research and development of new-age battery cathode materials. Our ability to synthesize battery cathode materials is enhanced by our manufacturing and research capabilities with a goal to produce high-quality cathode materials that meet the ever-evolving demands of the energy storage industry.
Our R&D team has successfully synthesized Prussian White, the reduced and sodiated form of Prussian Blue. We have developed an air-stable & crystalline form of Prussian White with high sodium content, having electrochemical properties and energy storage capacity similar to Lithium Iron Phosphate (LFP). Based on this success, we have decided to launch our own Battery Research Lab for in-house fabrication of R&D scale sodium-ion batteries and their electrochemical testing.
Integrating Artificial Intelligence across company departments:
Staying at the forefront of technological advancements, Macsen Labs has taken a significant leap forward by integrating Artificial Intelligence (AI) across various departments. This strategic enhancement is set to revolutionize our operational efficiency and data analysis.
Latest Developments in Regulatory Certifications –
USDMFs filing:
We completed the filing of DMFs with USFDA for two of our APIs, Fluorescein Sodium USP, a dye used as a diagnostic agent for fluorescence medical imaging & ophthalmic procedures, and Selenious Acid USP, a drug used for Selenium deficiency.
This underscores our commitment to upholding the highest standards in the production of pharmaceutical products and strengthens our position as a reliable and trustworthy API manufacturer.
Audits Conducted:
Our API manufacturing facility ‘Macsen Drugs’, which is WHO-GMP certified and US-FDA registered, obtained GMP certification from the Therapeutic Goods Administration (TGA) of Australia. With this, we are now also recognized as a PIC/S audited facility.
The GMP certification by TGA Australia is a confirmation that showcases our adherence to stringent quality control measures, rigorous documentation, and comprehensive process validation.
Expansion and Growth (Scale Up projects & Infrastructure) –
Validation batches completed of ICG:
During this period, the validation batches for Indocyanine Green have been completed in our API manufacturing facility, Macsen Drugs. Our DMF is under compilation and will be filed in May 2024.
Pilot Plant Functional:
In a significant stride forward, we also made our pilot plant fully operational. This key development is pivotal as it bridges the gap between laboratory-scale experiments and full-scale production, enabling us to scale up processes that have been successfully validated at the lab scale in the R&D. The functional pilot plant allows for rigorous testing and optimization of production techniques under real-world conditions, ensuring that our innovations are both efficient and economically viable before moving to plant scale operations.
Commissioning of Block-4:
2023-24 was a milestone year in terms of expansion. We enhanced our operational capabilities by opening a new block in our facility Macsen Drugs, located at RIICO Industrial Area, Gudli, Udaipur, Rajasthan, 313024, India. The block is equipped with state-of-the-art technology to increase our production capacity and streamline our processes. Our newly developed products, Deferiprone, Nicorandil, and Viloxazine, will be commercialized here.
Custom Synthesis Vertical Launched –
During the financial year 2023-24, Macsen Labs proudly launched its custom synthesis vertical, marking a significant expansion of our services. We have successfully onboarded a diverse group of customers and several projects have been initiated, demonstrating robust progress and promising outcomes. To support these endeavors, we utilized our existing state-of-the-art equipment, including LC-MS/MS, GC-MS/MS, ICP-OES, FTIR, and HPLC, ensuring top-tier research and development capabilities. In addition, we strengthened our analytical capabilities by acquiring an additional LC-MS and ICPMS system and have also upgraded our R&D capabilities by integrating software such as Reaxys (Elsevier). We look forward to serving more innovative projects in the coming years by offering our custom chemical synthesis services.
Community Engagement and CSR Activities –
Macsen is committed to giving back to the community. In continuation to our mission and values, we got an opportunity to be a part of a project of re-developing a government school in Odwadiya, Udaipur, Rajasthan. Under this project, we inaugurated the “N.K. Agrawal Memorial School Block” and built 14 new classrooms along with the renovation of the old school building.
As we step into the new fiscal year, we are excited about the opportunities that lie ahead. Our focus will remain on innovation and growth. Plans are already underway to launch new products and further expand into new markets.
We are grateful to our dedicated employees, loyal customers, and all our stakeholders for their continued support. Here’s to reaching new heights together in 2024-25!