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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.

  • Experts Dedicated Team

    50+

    Experts  
    Dedicated Team

  • State-of-the-art manufacturing facilities

    08

    State-of-the-art  
    Manufacturing facilities

  • DMF(Drug Master Files) across global markets

    1865

    DMF(Drug Master Files) 
    across global markets

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
  • USA337
  • Canada111
  • Europe (ASMF)173
  • Europe (CEP Filed)118
  • Australia91
  • New Zealand63
  • Brazil154
  • China114
  • Israel34
  • Japan52
  • Korea107
  • Russia51
  • Saudi Arabia70
  • Taiwan45
  • RoW345
Regulatory Filings Map
* As of May 2024

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

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.

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