The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22
Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions
18-year veteran Saharsh will position the CDMO as a premier global API process development and commercial manufacturing specialist
The Taipei facility boasts 10 GMP API production lines, with a total reactor volume exceeding 350,000 liters
One task, one interaction, one pair, experts advocate
On segmental performance, API revenues were largely stable at Rs. 454.3 crore for Q3 FY26, down 1% YoY
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
Plant 1 continues to serve as a core manufacturing hub for oral solid dosage forms
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