News | August 23, 2021
Zydus gets USFDA approval for arthritis drug
Zydus was the first to file an ANDA for Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength
Zydus was the first to file an ANDA for Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength
XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor
India’s dependency on China for pharma intermediates can change if there is a proper coordination between educational institutes, research institutes and pharma manufacturers
CDSCO to fast-track trials and approval for COVID19 vaccine
Osimertinib works by slowing or stopping the growth of cancer cells and binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors
It is expected that the drug substance would be available from August 2021 which will be supplied back to Bharat Biotech for producing COVAXIN
Financial support is being provided as a grant from the Government of India
Baricitinib was issued a restricted emergency use approval by the Central Drugs Standard Control Organization (CDSCO)
Baricitinib is an oral medication that was earlier registered in India for the treatment of moderate to severe active rheumatoid arthritis in adult patients.
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