Sanofi secures two breakthrough nods in China for rare blood disorders
Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia
Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
The plant can reach an annual capacity of 300 crore tablets and 90 crore capsules
The inspection concluded with one minor observation in Form 483
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
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