Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility
Inspection included drug device combinations covering our recent filing in nasal sprays domain
Inspection included drug device combinations covering our recent filing in nasal sprays domain
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
This inspection was conducted following the warning letter issued by the USFDA
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The facility has been classified as Voluntary Action Indicated
The company received one observation in the Form-483
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