Tag
USFDA
4 articles
OneSource USFDA Inspection Concludes with One Observation
OneSource Specialty Pharma discloses completion of a routine USFDA cGMP inspection at its Bengaluru sterile facility.
The inspection, conducted from June 22-30, 2026, concluded with a single observati
Ajanta Pharma Paithan Facility Receives USFDA VAI Classification
Ajanta Pharma received a Voluntary Action Indicated (VAI) classification from the USFDA for its Paithan manufacturing facility.
The USFDA inspection was conducted from April 13 to April 21, 2026, and
Alembic Pharmaceuticals Receives USFDA Approval for Dapsone Gel
Alembic Pharmaceuticals received final USFDA approval for Dapsone Gel, 5%, a generic equivalent to Aczone Gel for acne vulgaris treatment.
The approval marks the company's 244th ANDA approval from USF
Dr. Reddy's USFDA Inspection: 7 Observations at Bachupally
USFDA issued Form 483 with seven observations after Pre-License Inspection at Dr. Reddy's Bachupally biologics facility.
Inspection conducted from June 16 to June 25, 2026, requiring response within s