News | December 12, 2025
Granules Life Sciences facility receives EIR from USFDA
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The company will respond to the US FDA within the stipulated timelines
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The FDA aims to make a decision by April 8, 2026
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
The new centre brings advanced corneal procedures pioneered in India
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets
Roche says its new assay “resolves this challenge by delivering accurate and specific results
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
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
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