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Sai Life Sciences, Hyderabad-based Contract Research, Development & Manufacturing Organisation (CRO-CDMO), has announced the opening of a new High-Potency API (HPAPI) manufacturing facility at its cGMP API Manufacturing campus in Bidar, Karnataka. The addition of this new facility expands the company's expertise across HPAPI development and manufacturing, providing its customers with a streamlined pathway for new chemical entity (NCE) development.
The new 16000 sq. ft. HPAPI block, located in the Bidar Manufacturing Campus of the company, is designed and validated to handle high potent molecules less than 1 μg/m3 containment; it has inbuilt warehouse to store key starting materials (KSMs), intermediates and finished goods; it has dedicated sampling / dispensing area with isolators with three independent streams to handle commercial scale batches.
Earlier in 2022, the company had opened its HPAPI Development facility at its Hyderabad R&D campus. Now, with the addition of the new HPAPI production facility in Bidar, the company is capable of handling of all aspects of the project life cycle spanning process development, analytical development, particle engineering, warehousing, pilot, scale up, sampling, QC, powder processing, effluent treatment, packing, transportation and stability services.
Over the past couple of years, the company has undergone an intense phase of transformation as part of its Sai Nxt initiative, executing investments of over $120 million in its capacity and operations, expanding into new geographies, growing its scientific talent base, and raising the overall bar for quality, compliance and performance.
