50+

Experts Dedicated Team

08

State-of-the-art Manufacturing facilities

1971

Total DMF(Drug Master Files) across global markets

1629

Active DMFs

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.

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.

Geography Filings

  • USA 351
  • Canada 118
  • Europe (ASMF) 176
  • Europe (CEP Filed) 123
  • Australia 96
  • New Zealand 63
  • Brazil 169
  • China 115
  • Israel 35
  • Japan 55
  • Korea 114
  • Russia 52
  • Saudi Arabia 74
  • Taiwan 50
  • RoW 380
Geography Map

Regulatory Filing Updates

2025

Montelukast Sodium Japan Filing

2025

Ruxolitinib HemifumarateCanada

2025

ApixabanTaiwan

2025

Palbociclib Canada

2025

Deucravacitinib USA

2025

Finerenone USA

Disclaimer

No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.