The facility spans 8,050 Sq.Mt. with a total built-up area of 54,000 Sq.Ft. It includes a 21,000 Sq.Ft. production area, an 11,500 Sq.Ft. warehouse another 22400 Sq.Ft developed for utilities, R&D, QA, QC, and other ancillary requirements. Key equipment in the facility includes over 45 KL of reaction volume using SS316 and GLR reactors and glass assemblies, with potential expansion up to 100 KL. It accommodates capacities ranging from 0.1 KL to 8.0 KL, (GLR & SSR) supporting high vacuum and high-temperature distillation, hydrogenation, and cryogenic reactions. Filtration equipment such as centrifuges, ANFD, pressure filters, and Nutsch filters, along with various drying equipment like tray dryers and vacuum tray dryers, enhance the facility's processing capabilities. Our robust Quality Management Systems (QMS) strictly follows the minimisation of variance levels, elimination of defects, mitigation of risk ensure top-notch quality and continuous process improvement Quality control is maintained with advanced instruments like HPLCs, GCs, UV, and IR spectroscopy. And analyses like spectral, XRD are supplemented by outsourced services. At Mansfield we strictly adhere to quality guidelines and GMP practices. The facility's utilities include a 2 Ton/ Hr steam boiler, refrigeration systems for -20°C and +5°C, a nitrogen generation system, an RO puried water generation system, and a 320 KVA diesel generator for backup electricity. The R&D department is dedicated to innovating new procedures and improving existing manufacturing processes, driving future growth and enhancing customer service. This comprehensive setup underscores the facility's capability to support extensive industrial operations and continuous development.
At Mansfield, our process development and production expertise in synthetic organic chemistry spans various APIs and intermediates. We provide high-quality APIs at competitive prices, supported by strong R&D and a deep understanding of critical processes, meeting the strictest global standards. Our capabilities include reactions such as Grignard, Hydrogenation, Chlorination, and more, ensuring precision and regulatory compliance. We continuously invest in process development, enabling quicker market access and cost-effective production for our customers.
At Mansfield, our robust Quality Management Systems (QMS) ensure top-notch quality and continuous process improvement. By adopting a Quality by Design (QbD) approach, we identify and minimize variability, eliminate defects, and mitigate risks, boosting efficiency. Being honest, having high standards, and focusing on the customer are essential for creating safe and suitable APIs and ingredients.
At Mansfield, we leverage our extensive expertise in advanced analytical techniques and processes, adhering to ICH guidelines and GMP practices. We specialize in developing advanced analytical methods and specifications that align with the synthesis and crystallization of APIs. With deep knowledge of regulatory requirements, we ensure seamless compliance with evolving industry standards. Our team offers professional support backed by years of experience navigating regulatory challenges. Additionally, we excel in powder processing, customizing physical properties to meet specific customer needs, including polymorphic forms and other bulk properties for specialized formulations.
At Mansfield Pharma, we are your trusted API partner, committed to providing the best service to ensure timely approval. Our high-quality DMFs are tailored to meet regional requirements for specific market submissions. Our expert teams offer prompt and reliable support, ensuring compliance and seamless delivery.
We adhere to the highest standards in every aspect of our work, using our experience and resources to support our customers. We are dedicated to regulatory compliance and uncompromising product delivery from development to manufacturing.
