Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI

Lupin receives EIR from USFDA for Nagpur injectable facility

The EIR was issued following an inspection of the facility from September 8 to September 16, 2025

Zydus receives EIR for the injectable facility located at Jarod

This inspection was conducted following the warning letter issued by the USFDA

Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI

This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States

Glenmark Pharma gets VAI from FDA for Monroe facility

The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site

Solara’s Mangalore facility clears FDA inspection with VAI status

Granules India’s facility secures FDA EIR with 'VAI’

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025

Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1

The facility has been classified as Voluntary Action Indicated

NATCO Pharma API unit in Mekaguda receives EIR from USFDA

The company received one observation in the Form-483

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms