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.
Experts Dedicated Team
State-of-the-art Manufacturing facilities
Total DMF(Drug Master Files) across global markets
Active DMFs
Our Global Network
- USA367
- Canada121
- Europe (ASMF)185
- Europe (CEP Filed)130
- Australia100
- New Zealand63
- Brazil175
- China115
- Israel35
- Japan58
- Korea118
- Russia57
- Saudi Arabia85
- Taiwan55
- RoW436
* As of April 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
Empagliflozin P3
US
- 2026
Perflurohexyloctane
US
- 2026
Dapagliflozin P2
US
- 2026
Adagrasib Crystalline
US
- 2026
Finasteride Form-I
US
- 2026
Pentosan polysulfate sodium
US
- 2026
Pirtobrutinib Crystalline
US
- 2026
Tafamidis Form 4
US
- 2026
Tirzepatide
US
- 2026
Enzalutamide Premix
Brazil DMF
- 2026
Edoxaban Tosylate
Japan DMF
- 2026
Atorvastatin Calcium Trihydrate [Form-I] [AFP Process]
Europe (CEP)
