13 Chemistry, Manufacturing, and Controls (CMC) The CMC business of Sai Life Sciences offers customers comprehensive capabilities from process development through to scale-up and early phase supplies. Over the last two decades, the company has consistently delivered a diverse set of NCE development programs for its customers with a track record of bringing value based on quality, pricing and responsiveness. Today, Sai Life Sciences works with 17 of the top 20 global pharmaceutical companies, in addition to several biotechs, small & mid pharma companies across USA, EU, UK, and Japan. It has 31 commercial products and 11 Phase III products in its portfolio. The CMC vertical of Sai Life Sciences has over 1700 employees across its sites in Manchester, Hyderabad and Bidar. • Process R&D Lab, Manchester: Set-up at Alderley Park in June 2020, the lab assists customers in developing routes and processes for their small molecule drug substances. The site has a team of 70+ scientists and complementing facilities including a fully equipped analytical laboratory, GMP Scale-up facilities, 21CFR Part 11 Compliant software and robust model for early phase tech transfer to India sites. • Research & Technology Centre, Hyderabad: The 450-member scientific team in Hyderabad has comprehensive capabilities spanning Process R&D, Analytical R&D, Process Safety, Quality Control, Process Engineering & Scale-up and Pilot facilities. It has advanced capabilities and technologies including Bio Catalysis, Flow Chemistry, Chemo Catalysis, Continuous Extraction, Continuous Distillation, Lyophilization, Amidites and HPAPI capabilities. • Manufacturing site, Bidar: The 450 KL capacity manufacturing site supplies APIs and advanced Intermediates for highly regulated markets including USA, EU and Japan. The site has undergone multiple successful audits by the USFDA, PMDA (Japan) in addition to over 600 audits by large pharma companies. The site operates at a containment level of 1 μg/m3, has 11 clean rooms of ISO – 8, dedicated blocks for amidites and HPAPIs (0.1 μg/m3) capability, in addition to capabilities including lyophilization at pilot & commercial scale, high pressure reactions, chromatography at commercial scale and cryo reactions at 2.5 KL, 4 KL & 5 KL scale. Delivering complex chemical synthesis from development to commercial scale
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