Mankind Pharma acquires Bharat Serums from Advent International for ₹13,630 crore. Learn More
Ensuring global standards and quality, embedding excellence and innovation in every step of our safety assurance process.
Mankind fosters a robust quality culture, exceeding regulatory standards through a harmonized approach. Committed to continuous improvement, we ensure safe, efficacious products by maintaining comprehensive quality assurance from material sourcing to manufacturing to customer touchpoints.
Guided by Global Standards
ICH
International Council for Harmonisation (ICH)
FDA
US Food and Drug Administration (USFDA)
edqm
European Pharmacopeia (EP)
CDSCO
Central Drugs Standard Control Organisation (CDSCO)
National Sanitary Vigilance Agency (Brazil)
National Sanitary Vigilance Agency (Brazil)
Pharmaceutical Inspection Co-operation Scheme
Pharmaceutical Inspection Co-operation Scheme
European Medicines Agency
European Medicines Agency
Intellectual Property (IP) Laws
Quality by
Excellence (QbX)
Programme
At Mankind, the pursuit of quality is an unceasing journey towards a mature establishment and evolving milestones. The QbX Programme exemplifies this commitment. The key focus areas of the QbX programme are:
  • Regulatory Compliances
  • Increasing People Competencies
  • Developing Lean Laboratory Concepts
  • Process Enhancement
  • Documentation Simplification
  • Productivity Enhancement
Compliance &
Regulatory
Our commitment to quality is enforced through stringent adherence to international and national regulatory standards. Mankind Pharma is dedicated to ensuring that all our processes and products meet the rigorous safety, quality, and efficacy standards.
1
Complies with the Drug and Cosmetic Act 1940, 21 CFR Part 210 and 211 for the US, EudraLex for Europe, PIC/S guidelines, ANVISA for Brazil and Schedule-M.
2
Empower & Encourage people to follow quality checks from raw materials to final product release, ensuring every dose meets quality and safety standards.
3
Conduct regular audits of manufacturing sites by internal and corporate teams, with periodic management reviews to ensure high standards and continuous improvement.
Successfully completed 23 international regulatory inspections, affirming our global standards.
Enhancing quality
through our people
At Mankind Pharma, our commitment to quality is reinforced through our people-focused initiatives. These programs are designed to enhance our team's capabilities and engagement in maintaining the highest standards
Our comprehensive Quality
Policy Document