US FDA issues 17 observations for Biocon Biologics sites
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
The Centre aims at promoting innovation among the scientific community to improve healthcare solutions around the globe
99% of Pristyn Doctors are using EMR facility on its doctor app
The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest
Phase 1 has already been executed with the construction of temporary OPD, guest house and boundary wall and Phase 2 of the execution is being fast tracked
The company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner
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 will be manufactured at Lupin's facility in Goa, India.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
The estimated capex is to the tune of Rs. 140 crore to be funded through debt and internal accrual
Subscribe To Our Newsletter & Stay Updated