Shilpa Medicare gets USFDA nod for Tenofovir Alafenamide Tablets
New Delhi: Shilpa Medicare has recently announced that the Company has received U.S Food and Drug Administration (USFDA) tentative approval for its Abbreviated New Drug Application (ANDA), Tenofovir Alafenamide Tablets, 25 mg on 15 Sep 2022.
The ANDA was filed as 'First to File' submission on NCE -1 date.
Tenofovir Alafenamide Tablets, 25 mg is a generic equivalent of reference listed drug (RLD) Vemlidy tablets, of Gilead Sciences Inc. used in the treatment of chronic hepatitis B virus infection as recommended in the label approved by FDA.
Hepatitis B is a viral infection that causes inflammation of the liver. Chronic HBV infection occurs when the virus remains in a person's body. People living with chronic HBV can spread the virus to others, even if they do not feel or look sick themselves. Over time, chronic HBV can cause scarring of the liver, liver failure, liver cancer, or even death.
According to IQVIA MAT Q2 2022 data, the US market for Tenofovir Alafenamide Tablets, 25 mg is approximately US$ 498.14 Million.
Read also: Shilpa Biologicals gets NoC to conduct trials of biosimilar Aflibercept
Shilpa Medicare Limited 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. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
Read also: Shilpa Biologics, Mylab ink pact to enter vaccine, therapeutics segment
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