Grounded in Values, Strengthened by Systems.
Quality is a foundational principle that shapes how we operate, how we scale and how we build long-term credibility with customers and regulators. As the business expands across geographies, products and modalities, consistency in quality systems remains central to our approach.
We operate with a clear philosophy of “one quality standard for all markets”, applying the same rigour, discipline and compliance standards across products, facilities and customer engagements, whether the destination is the US, India, Africa or any other market. This values-led approach reflects our belief that quality should not vary by geography, economics or regulatory category.
Global Compliance Track Record
Our manufacturing network continues to meet the expectations of leading global regulators, supported by a strong track record of inspections and certifications. The regulatory inspection record since inception includes 21 inspections by USFDA, 15 by WHO-Geneva, 10 by ANVISA, 8 by PMDA, and 18 by European agencies, along with inspections by other agencies, taking the total number of site-wise inspections to 115, excluding audits by the Indian drug regulator. In addition, the network undergoes more than 100 customer audits each year, with customer expectations increasingly extending to digital-readiness and system maturity.
Quality Systems at Scale
Our quality framework is designed to operate across development, manufacturing and technical operations through a common set of standards, systems and oversight mechanisms. A single SOP structure is applied across sites to support consistent GMP practices and aligned execution across a multi-site, multi-product network. Audit-driven changes, once adopted, are implemented across sites to reinforce standardisation and reduce variability.
At the same time, phase-specific quality requirements for early-stage molecules provide greater flexibility where appropriate, helping balance speed, control and cost competitiveness without compromising the underlying quality framework.
Digitisation and Quality Infrastructure
The Quality framework is being strengthened through a series of digital initiatives. Electronic Lab Notebooks have been in use across analytical, process and formulation R&D for over a decade. Other digitisation priorities include automated method-validation workflows, wider electronic data capture in manufacturing, expanded SAP usage in warehouses and QR-code-based controls to reduce manual errors. LIMS has recently gone live at one unit and is planned for rollout across additional sites over the coming year.
Oversight and Continuous Strengthening
Oversight is supported not only through site-level QA structures, but also through a dedicated Development QA and Compliance (DQA) function that operates with a broader cross-site lens. This function conducts internal and regulator-style audits, performs random compliance verifications and reviews day-to-day activities independent of routine site operations. Its observations feed into awareness campaigns, cross-site comparisons and targeted closure of compliance gaps, supporting continuous improvement across the network.
Execution Discipline and Reliability
Quality performance is reflected not only in inspection outcomes, but also in the discipline and consistency of routine execution across sites and functions. Operational improvements continue to support this discipline. For example, tighter QC turnaround targets have shortened release timelines for recovered solvents to within 24 hours, helping reduce solvent storage and consumption. Such improvements reflect a wider emphasis on strengthening responsiveness, reducing process inefficiencies and embedding quality into day-to-day operations rather than treating it as a checkpoint at the point of inspection.
Our Quality Performance
1,400+
Quality audits and inspections conducted by global customers and regulatory authorities since inception
54
Inspections successfully cleared across major regulators including US FDA, WHO, EMA and PMDA
132
Quality audits completed during FY 2025-26 across regulatory and customer audits
Zero
Product recalls over the last five years