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 MOU provides for assistance in the form of efficient working Capital Management, development and commercialisation of new products, logistic supply chain management support etc.
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
Themis Medicare’s VIRALEX is an effective and safe drug for management of mild to moderate COVID and other acute viral respiratory infections.
The icare4u program features a dedicated website, with comprehensive information about the diseases, videos with medical experts, and a social media community for patients and caregivers on Facebook and YouTube
Viralex (Inosine Pranobex) is an immunomodulatory agent with broad-spectrum antiviral properties
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
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