White Paper

A closer look on how Dr. Reddy's met the stringent regulatory requirement of genotoxic impurities in Ranolazine

Genotoxic impurities (GTIs) have recently challenged the pharmaceutical industry by virtue of their presence at a level of parts per million (ppm) in drug products, especially in high dosage molecules like Ranolazine, which has a prescribed maximum daily dosage (MDD) of 2000 mg.

In this whitepaper, we talk about steps taken by Dr. Reddy's during the product development phase to address this challenge by designing the process in such a way that all these PGIs / GTI’s are within the control in the manufacturing approach followed by Dr. Reddy’s for Ranolazine.

Read our latest whitepaper on this topic by filling the contact form below.

You can also explore our Ranolazine API offering by clicking on the link below:

https://api.drreddys.com/product/ranolazine

Explore other Whitepapers:

Know More

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

Download Now

Please fill the Contact form below in order to view the white paper

* I agree and accept the Privacy Policy and Terms of Use of this website.

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

Disclaimer

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.

Let’s talk API sourcing live at

Tackle sourcing bottlenecks and compliance hurdles

Hall E1 Booth H28 24-26 June 2025, Shanghai

Book a Meeting