News | December 19, 2022
Shilpa Medicare introduces cancer drug Capecitabine 1000 MG dispersible tablet
The product is backed by required scientific proof and comparative bioequivalence studies
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 facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties
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
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