Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
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
Shilpa's Paracetamol oral thin films are patent protected and are first of this kind in the world
The GMP certificate is valid for three years until April 2024.
Targeted production of the dual vector Sputnik V for the first 12 months is 50 million doses from the date of start of commercial production
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