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Shilpa Medicare gets USFDA nod for Gemcitabine to treat types of cancer


Shilpa Medicare gets USFDA nod for Gemcitabine to treat types of cancer

The company has received US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA), Gemcitabine for injection USP in the strengths of 200 mg/vial and 1 g/vial, Shilpa Medicare said in a BSE filing.

New Delhi: Shilpa Medicare on Monday said it has received approval from the US health regulator for Gemcitabine for injection, used for the treatment of various types of cancers. The approved product is a generic equivalent of reference listed drug Gemzar.

The company has received US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA), Gemcitabine for injection USP in the strengths of 200 mg/vial and 1 g/vial, Shilpa Medicare said in a BSE filing.

Read Also: Shilpa Medicare gets tentative USFDA nod for Dimethyl Fumarate delayed release capsules

Gemcitabine for injection USP is used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and pancreatic cancer.

Quoting IQVIA MAT data for December 2018, Shilpa Medicare said, the US market for Gemcitabine for injection USP, 200 mg/vial and 1 g/vlal is approximately USD 11.7 million.
Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989.
 

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