Whitepapers

Tech sheet: Dr. Reddy's Olaparib API Offerings

Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostases, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib is indicated:

1. As monotherapy in patients with deleterious or suspected deleterious germline.
2. BRCA (breast cancer gene) mutated (as detected by an FDA-approved test) or advanced ovarian cancer after three or more prior lines of chemotherapy.

Lynparza® is the leading PARP (poly (ADP-ribose) polymerase inhibitor approved in over 64 countries to treat ovarian cancer and in 40 countries for breast cancer. Below are the timelines of FDA approvals of Olaparib across indications.

Dr. Reddy’s is among the earliest generic API manufacturers globally to file the USDMF for Olaparib API. In addition to the USDMF, considering the requirement of country-specific regulatory filings, we plan to diversify our drug master files (DMFs) with regulatory filling across various countries

To know more about our API offerings, please read the technical sheet on Olaparib by filling the contact from below.