This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years
This approval has come from the company's finished dosage form manufacturing facility
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
The product is backed by required scientific proof and comparative bioequivalence studies
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
Subscribe To Our Newsletter & Stay Updated
_256_275.jpg)