Regulatory Affairs: Global Expertise, Proven Compliance
Dr Reddy’s has an unmatched global 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
- USA356
- Canada121
- Europe (ASMF)183
- Europe (CEP Filed)126
- Australia100
- New Zealand63
- Brazil174
- China115
- Israel35
- Japan57
- Korea115
- Russia56
- Saudi Arabia83
- Taiwan51
- RoW417
* As of dec 2025
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
- 2025
Atorvastatin Calcium Trihydrate [Form-I]
USA
- 2025
Nilotinib Premix (HPMC AS)
USA
- 2025
Abemaciclib
Canada DMF
- 2025
Sumatriptan Succinate
Japan DMF
- 2025
Tafamidis Meglumine
Canada DMF
- 2025
Rivaroxaban (Process-II)
USA
- 2025
Naratriptan Hydrochloride
Russia DMF
- 2025
Lomustine
Russia DMF
- 2025
Fondaparinux Sodium
Saudi Arabia
- 2025
Fondaparinux Sodium
EU