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As we close 2025 and welcome 2026, we are proud to share a groundbreaking achievement. On December 30, 2025, we successfully submitted the U.S. Drug Master File (USDMF) for the Continuous Manufacturing Process established and validated for the Atorvastatin Calcium Trihydrate (Form-I) API, to the U.S. FDA.
This is a significant achievement in our journey toward advanced pharmaceutical manufacturing. Our team successfully implemented continuous processing across multiple unit operations including multi-step reactions, crystallization, filtration, and drying all integrated seamlessly into a robust and efficient workflow. This breakthrough not only enhances process efficiency and product quality but also reinforces our commitment to operational excellence, sustainability, and patient safety. By leveraging cutting-edge technology and collaborative expertise, we’ve set a new benchmark for delivering high-quality products with reduced cycle times and improved consistency.
This milestone underscores our dedication to innovation, quality, and regulatory excellence. The transition to continuous manufacturing represents a transformative step forward, delivering greater efficiency, consistency, and sustainability in pharmaceutical production. We extend our deepest gratitude to every team member for their relentless commitment, collaboration, and precision throughout development, execution, and documentation. Your efforts have been pivotal in achieving this success.
Together, let’s build on this momentum as we advance toward regulatory approval and unlock new opportunities in the future. For queries, please contact us at [email protected]
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