Regulatory Affairs: Global Expertise, Proven Compliance

Dr. Reddy’s offers unmatched regulatory expertise across international markets, ensuring our APIs meet the most stringent global standards. Our Regulatory Affairs (RA) team, with over 50 specialists, actively monitors evolving guidelines and proactively manages risk to support smooth approvals for complex APIs.

Global Reach & Proven Track Record

  • DMFs filed across the U.S., Europe, Russia, Canada, China, Japan, Brazil, and more
  • Expertise in DMF, CMC, IND, and NDA filings
  • Strong partnerships with specialized law firms across geographies
  • Facilities regularly audited by USFDA, EMA, WHO GMP, PMDA, KFDA, ANVISA, Health Canada, and others

Our regulatory strength ensures faster market access and reliable compliance for our global partners.

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50+

Experts Dedicated Team

8

State-of-the-art Manufacturing facilities

2177

Total DMF(Drug Master Files) across global markets

1736

Active DMFs

Our Global Network

  • USA370
  • Canada122
  • Europe (ASMF)193
  • Europe (CEP Filed)131
  • Australia100
  • New Zealand64
  • Brazil186
  • China115
  • Israel35
  • Japan58
  • Korea119
  • Russia57
  • Saudi Arabia88
  • Taiwan58
  • RoW481
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* As of November 2026

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.

Regulatory Filing Updates

  • 2026

    Ruxolitinib Base

    Korea

  • 2026

    Fluoxetine Hydrochloride

    Brazil DMF

  • 2026

    Abemaciclib

    EU

  • 2026

    Ribociclib Maleate

    USA

  • 2026

    Dapagliflozin Propanediol

    EU

  • 2026

    Ribociclib Maleate

    Brazil DMF

  • 2026

    Eslicarbazepine acetate

    Brazil DMF

  • 2026

    Finasteride form-I

    Brazil DMF

  • 2026

    Canagliflozin Hemihydrate

    EU