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Product Alert – Vonoprazan Fumarate

Product Alert – Vonoprazan Fumarate

Dr. Reddy's Offerings:

  • USDMF filed in februray 2024
  • Offers crystalline innovator form.

Our API adheres to ICH M7 guidelines for genotoxic impurity (GTI) profiles, and we are actively evaluating strategies for nitrosamine impurities. We have also employed a robust process to achieve the consistent polymorph (innovator form) and morphology to ensure the desired in-vivo performance.

Our cGMP API manufacturing facility has undergone a thorough inspection by international regulatory authorities, and we have reliable suppliers for key starting materials to ensure timely deliveries and adherence to strict specifications. Moreover, we are equipped to provide sufficient capacity to supply development quantities within a short lead time of 90-120 days.

To learn more about our API offerings, please read the product alert on Vonoprazan API by filling out the contact form below.

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Email us: api@drreddys.com | +91 40 49002222

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.