Drug Approval | September 22, 2022
Shilpa Medicare receives tentative approval for Tenofovir Alafenamide Tablets
The ANDA was filed as 'First to File' submission on NCE-1 date.
The ANDA was filed as 'First to File' submission on NCE-1 date.
The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets
The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing
The GMP facility is equipped with state of art machinery for the needs of Global commercial requirements
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
Aflibercept is the second biosimilar product that has entered the clinical trial phase after biosimilar Adalimumab
Prucalopride medicine in the form of Orally Disintegrating Strips are most convenient dosage form for geriatric patients
Equity raise to finance growth and investments in the biological space
ZyCoV-D is the first DNA plasmid vaccine in the world for human use, developed indigenously by the company against the Covid-19 virus
The powder is approved for the treatment of adjunct therapy in moderate to severe Covid-19 patients
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