Regulatory

Dr Reddy’s has an unmatched global regulatory expertise focused on international markets. Our top-class quality and industry-leading compliance are designed to ensure our products meet stringent requirements globally.

Our Regulatory Affairs (RA) team is one of the strongest in the industry. We have a dedicated team of more than 50 experts in regulatory affairs. Our team of regulatory experts understands the complex issues associated with regulatory agencies and assists in the approval of each complex API by analyzing the latest regulatory trends, quality requirements through active monitoring and proactive assessment of potential risks.

• 

  50+

  Experts  
  Dedicated Team

• 

  08

  State-of-the-art  
  Manufacturing facilities

• 

  1909

  Total DMF(Drug Master Files) 
  across global markets

• 

  1572

  Active DMFs

Dr. Reddy's global regulatory team is well-versed with submissions across all regulatory markets to support local & worldwide market access strategies. Our regulatory team is accompanied by a broad network of law firms across geographies specialized in the pharmaceutical sector. We have more than 1800+ Drug Master Files (DMF) across the global markets like the United States, Europe, Russia, Saudi Arabia, Israel, China, Japan, and Brazil.

We understand the local market with broad market research & delivers high-quality regional specific DMFs to meet the regulatory requirements. Dr. Reddy's API business thrives on the deep technical strengths set up over the last 40+ years in consistently delivering high-quality APIs and manufacturing complex APIs. We follow best practices to improve our DMFs to match with the latest FDA regulatory standards. In addition, our expert Regulatory affairs & Quality teams follow the highest global standards of quality and regulatory compliance.