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.
Especialistas em Equipe Dedicada
Instalações de Fabricação de Última Geração
Total DMF (Arquivos Mestres de Medicamentos) nos mercados globais
DMFs ativos
Our Global Network
- EUA367
- Canadá121
- Europa (ASMF)185
- Europa (outorgado pela CEP)130
- Austrália100
- Nova Zelândia63
- Brasil175
- China115
- Israel35
- Japão58
- Coreia118
- Rússia57
- Arábia Saudita85
- Taiwan55
- RoW436
* As of April 2026
Entendemos o mercado local com ampla pesquisa de mercado e fornecemos DMFs específicos regionais de alta qualidade para atender às exigências regulatórias. O negócio de Princípios Ativos Farmacológicos (Active Pharmaceutical Ingredient, também abreviados como API) do Dr. Reddy prospera com os profundos pontos fortes técnicos estabelecidos nos últimos 40+ anos no fornecimento consistente de APIs de alta qualidade e na fabricação de APIs complexas. Seguimos as melhores práticas para melhorar nossos DMFs de acordo com as mais recentes normas regulamentárias da FDA. Além disso, nossas equipes especializadas em Assuntos Regulamentários e Qualidade seguem os mais altos padrões globais de qualidade e conformidade regulatória.
Regulatory Filing Updates
- 2025
Atorvastatin Calcium Trihydrate [Form-I]
USA
- 2025
Nilotinib Premix (HPMC AS)
USA
- 2025
Abemaciclib
Canada
- 2025
Sumatriptan Succinate
Japan
- 2025
Tafamidis Meglumine
Canada
- 2025
Rivaroxaban (Process-II)
USA
- 2025
Naratriptan Hydrochloride
Russia
- 2025
Lomustine
Russia
- 2025
Tizanidine Hydrochloride
CEP DMF Filed
- 2025
Fondaparinux Sodium
Saudi Arabia
- 2025
Fondaparinux Sodium
EU
Aviso legal
No information on this website, 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, in certain cases, at Dr. Reddy's sole discretion, and subject to local legal requirement, the research quantities of such products may be offered for the purpose of regulatory submissions under Section 107A of the Indian Patent Act (Bolar exemption), wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the product or service including, patent scenario in their respective markets and will be responsible for all patent related liabilities Dr. Reddy's disclaims all warranties, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose and non-infringement.