Whitepapers

Tech Sheet - Dr. Reddy’s Gemcitabine API offerings

Gemcitabine Hydrochloride is an analog of the antimetabolite nucleoside deoxycytidine with antineoplastic activity. Gemcitabine is converted intracellularly to the active metabolites difluorodeoxycytidine di-and triphosphate (dFdCDP and dFdCTP)

The timelines of USFDA approval of Gemcitabine Hydrochloride across indications are as follows:

1. U.S. Food and Drug Administration (USFDA) approved Gemcitabine Hydrochloride to treat non-small cell lung cancer in 1998 and for treating metastatic cancer in 2004.
2. The U.S. Food and Drug Administration (USFDA) has approved Gemzar® (Gemcitabine Hydrochloride), in combination with Taxol® (paclitaxel), providing a new option in first-line therapy for women battling metastatic breast cancer in 2004. In addition to the United States, Gemzar has been approved for metastatic breast cancer in 32 countries today.
3. Gemzar is approved in more than 90 countries and is the worldwide standard of care for pancreatic cancer and non-small cell lung, bladder, and breast cancers in many parts of the world.

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