News | June 03, 2026
Granules Pharmaceuticals receives USFDA EIR for Chantilly facility
This facility plays an important role in Granules’ global manufacturing and supply network
This facility plays an important role in Granules’ global manufacturing and supply network
The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026
Inspection outcome reinforces company's compliance track record and strengthens its ability to serve regulated markets including the United States
The EIR was issued following an inspection of the facility from November 10 to November 21, 2025
Transcenta will grant EirGenix a non-exclusive license to its Highly Intensified Continuous Bioprocessing (HiCB) platform
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
This inspection was conducted following the warning letter issued by the USFDA
Indian companies must make their own intermediates and support small industries: Dr. K. Nagaiah, Chief Scientist, CSIR - IICT, Hyderabad
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