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SAI Life Sciences Completes Phase II Expansion at Bidar, Boosting Capacity to 700 KL

SAI Life Sciences, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), has marked a significant milestone with the completion of Phase II of its Production Block 11 (PB-11) at its flagship manufacturing facility in Bidar, Karnataka, India. This strategic expansion elevates the company’s total installed reactor capacity to an impressive 700 kiloliters (KL), reinforcing its position as a trusted partner for global pharmaceutical and biotech companies.

A Major Step in Capacity Expansion

The completion of Phase II of PB-11, announced on August 28, 2025, adds approximately 91 KL to the existing 110 KL capacity from Phase I, which was inaugurated in December 2024. This brings the total capacity of PB-11 to around 200 KL, making it the largest reactor volume block at the Bidar site. With this expansion, SAI Life Sciences’ Unit IV in Bidar now boasts a total manufacturing capacity of 700 KL across 12 production blocks, designed to meet the growing demand for Active Pharmaceutical Ingredients (APIs) and advanced intermediates for highly regulated markets, including the US, EU, and Japan.

This expansion aligns with SAI Life Sciences’ commitment to scalability, reliability, and innovation, enabling the company to handle large-scale commercial products and complex projects with greater efficiency. According to Krishna Kanumuri, CEO and Managing Director of SAI Life Sciences, “Our clients are at the heart of everything we do. This expansion goes beyond additional capacity, aiming to provide confidence in our ability to deliver on increasingly sophisticated requirements.”

Global Regulatory Compliance and Advanced Capabilities

The Bidar facility is a cornerstone of SAI Life Sciences’ operations, specializing in the production of APIs and intermediates for both clinical and commercial purposes. It is equipped with state-of-the-art capabilities, including:

  • High-Potency API (HPAPI) Manufacturing: Dedicated facilities to handle highly potent molecules with containment levels below 1 μg/m³, critical for oncology drugs and other specialized therapies.

  • Advanced Technologies: Capabilities such as lyophilization, cryogenic reactions, high-pressure reactions, and commercial-scale chromatography, ensuring flexibility for diverse chemical processes.

  • Regulatory Approvals: The facility has a 100% successful track record with inspections from leading global regulatory agencies, including the USFDA, PMDA (Japan), and CDSCO (India). As of March 2025, the Bidar site has undergone over 75 customer audits in the past three years, underscoring its commitment to quality, safety, and compliance.

These approvals enhance SAI Life Sciences’ export readiness, enabling seamless supply to highly regulated markets. The facility’s adherence to global standards, such as ICH Q7 and 21 CFR Part 210/211, ensures compliance with the stringent requirements of international pharmaceutical markets.

Strengthening the Pharmaceutical Supply Chain

The expanded Unit IV facility in Bidar is designed to manufacture Registered Starting Materials (RSMs), intermediates, and APIs, catering to both clinical trials and commercial-scale production. With the completion of the 195 KL expansion project (Phase I and II combined), SAI Life Sciences is well-positioned to meet the rising global demand for high-quality pharmaceutical ingredients. The facility’s advanced automation systems, containment technologies, and quality control laboratories further enhance its ability to deliver consistent, high-quality products.

This milestone strengthens SAI Life Sciences’ role in the global pharmaceutical supply chain, supporting over 300 innovator pharma and biotech companies in accelerating the discovery, development, and commercialization of new chemical entities (NCEs). The company’s focus on sustainability, quality, and innovation ensures it remains a preferred partner for pharmaceutical development.

Looking Ahead

The completion of Phase II at Production Block 11 is a testament to SAI Life Sciences’ vision of supporting the launch of 25 new medicines by 2025. With its expanded capacity, cutting-edge technology, and unwavering commitment to quality, the Bidar facility is poised to drive pharmaceutical innovation and meet the evolving needs of its global clients.

For more information about SAI Life Sciences’ capabilities and services, visit www.sailife.com.

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