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 product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
The product will be manufactured at Lupin's facility in Goa, India.
OrderPoint was designed as an advanced DTR solution from its first release in 2016.
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
GlobalData’s ‘Pharmaceutical Intelligence Center’ observes that India is still in the nascent stage of developing these potential therapies as currently only four cell/gene therapy molecules are being developed in the country.
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
The study concluded that elevated levels of two proteins help predict how a person will recover from a traumatic brain injury (TBI), providing important information to determine appropriate care
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
The estimated capex is to the tune of Rs. 140 crore to be funded through debt and internal accrual
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