Alembic Pharmaceuticals receives EIR for API - I and API - II facility located at Panelav

The inspection was carried out between May 26, 2025 and May 31, 2025

Briefs: Alembic Pharmaceuticals and Tyche Industries

Alembic receives EIR from USFDA for facility at Panelav

FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US

Sun Pharma's Halol plant gets OAI classification from US FDA inspection

Alembic gets FDA final approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe

FDA grants Fast Track Designation for Teva’s Emrusolmin

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity

FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia

ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life

Sai Life Sciences completes Phase II of production block 11 at Bidar

With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL

Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra

The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion