The inspection concluded with one minor observation in Form 483
Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
The companies aim to expand treatment options for millions living with metabolic disorders
LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure
The product will be marketed by Dr. Reddy's Laboratories Inc.
The company will respond to the US FDA within the stipulated timelines
India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines
India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines
The partnership also allows both companies to explore CR-001 and SKB105 as monotherapies and in combination
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