Investing in Advanced API Technology for High-Quality and Scalable Pharmaceutical Solutions

Microsin is thrilled to announce the successful validation of Alpha Lipoic Acid production on our newly established manufacturing line. This milestone reinforces our position as a leading API manufacturer, enhancing our capacity to deliver high-quality active pharmaceutical ingredients to global markets.

Advanced Manufacturing Line: Key Investment for Growth

Our new manufacturing line, representing an investment of over €2 million, showcases our commitment to innovation and scalable production. The facility is equipped with cutting-edge technology, including three reactors for diverse synthesis capabilities, three process filters to ensure top-tier product purification, a centrifuge and Frewitt mill for precision processing, and a 1300L Syntegon fluid bed drier for high-volume drying efficiency.

This upgrade included expanding our cleanroom area and installing a modern HVAC system, meeting stringent regulatory and environmental standards. These enhancements enable Microsin to achieve a production capacity exceeding 500 MT of APIs per year and batch sizes of up to 600 kg.

Following a detailed inspection by the Romanian National Agency for Medicines and Medical Devices, the new line received certification, extending the validity of our GMP certificate for three years. This validation reinforces our long-term strategy of improving pharmaceutical manufacturing efficiency while maintaining the highest levels of quality assurance.

Alpha Lipoic Acid Process Validation: Delivering Quality and Consistency

The process validation for Alpha Lipoic Acid began on November 19th, 2024, following the strict guidelines of validation plan VAL-ALA-03. Over three batches, we successfully achieved a target batch size of 540 kg for all runs, full compliance with European Pharmacopoeia standards, and high yield rates with consistent, pharma-grade quality.

This achievement confirms our ability to produce cost-effective APIs without compromising on quality, positioning Microsin as a trusted partner for pharmaceutical companies worldwide. Moreover, it highlights our dedication to process optimization, ensuring both efficiency and sustainability in large-scale API production.

Future Plans: Scaling Innovation Across More APIs

Microsin is committed to leveraging the capabilities of our new production line for a diverse range of APIs. In December 2024, we plan to validate the manufacturing processes for Lithium Orotate Monohydrate with a batch size of 350 kg and Metoprolol Tartrate with a batch size of 250 kg.

These expansions demonstrate our dedication to providing innovative solutions for API production and meeting the growing demands of the global pharmaceutical industry. Additionally, we are exploring future process improvements that will further enhance manufacturing speed and cost efficiency while maintaining compliance with evolving regulatory standards.

Why This Investment Matters

The new manufacturing line represents more than just additional capacity—it underscores Microsin’s focus on efficiency through optimized processes for cost-effective production, sustainability by adopting energy-efficient equipment and reducing environmental impact, scalability with the ability to produce large batch sizes and support diverse APIs, and reliability by strengthening our ability to meet increased demand with high-quality pharmaceutical ingredients.

This investment solidifies our long-term vision of developing an advanced, sustainable, and globally competitive production infrastructure. By integrating cutting-edge technology and maintaining compliance with the highest quality standards, Microsin continues to build its reputation as a leader in API manufacturing.

As we move forward, we remain committed to research and innovation, identifying new opportunities to expand our portfolio and deliver the highest-quality pharmaceutical solutions to our global partners.ring.

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